The Effect of Structured Exercise on Chronic Venous Insufficiency: A Feasibility Trial
Phase: NA
Conditions: Chronic Venous Insufficiency
Sponsor: Shannon Hernon

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The Effect of Structured Exercise on Chronic Venous Insufficiency: A 
Feasibility Trial
May 1st, 2018
Shannon Hernon 
National University of Ireland Galway 

 
 
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ABBREVIATIONS 
 
BMI 
 
Body Mass Index 
BW 
 
Body Weight 
CVI 
 
Chronic Venous Insufficiency 
DF 
 
Dorsiflexion 
EF  
 
Ejection Fraction 
PAR-Q 
Physical Activity Readiness Questionnaire 
PF 
 
Plantar Flexion 
PPG  
Photo-plethysmography 
PT 
 
Peak Torque 
ROM  
Range of Motion 
RVF  
Residual Volume Fraction 
SFW  
Strength from Within 
VRT  
Venous Return Time 
VT1 
 
Ventilation Threshold 1 
VV 
 
Venous Volume 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. STUDY BACKGROUND 

 
 
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Chronic Venous Insufficiency (CVI) results from the disruption of normal blood 
transportation, whether the disruption occurs in the superficial or deep venous 
system, the perforating veins or any combination of these1. When the perforator 
valves become compromised, pressure in the calf muscle contraction increases and 
blood begins to flow through the compromised perforator veins into the superficial 
venous system resulting in venous hypertension or varicose veins1.  Varicose veins 
are known as common venous incompetence in the lower extremities and appear as 
dilated, elongated, or winding superficial veins2. Venous pressure in the lower legs 
results from damaged deep, superficial and or perforating veins and over time this 
can lead to changes in the skin such as hyperpigmentation, edema, and can lead to 
ulceration2. It is essential for individuals to have regular contraction of the calf 
musculature as it controls lower extremity venous return2. The calf muscle pump 
function is known as the “peripheral heart” for its crucial role in an individual’s calf 
muscle pump function4. Once there is long-term weakness in the calf musculature 
the blood flow to the lower extremity slows down and increases the risk for a deep 
venous thrombosis2. With many theories leading to the valve reflux being the main 
cause of varicose veins there has been no evidence to show that if the compromised 
primary valve initiates the process of varicose veins or if the dilatation or weakening 
of the vein walls and collagen composition is the cause. 
CVI is a highly reported chronic medical condition in the United States and the 
Western world1. In the United States alone over 2.5 million individuals are affected 
by chronic venous disease with prevalence ranging in geographical locations1,3. 
Beebe-Dimmer et al (2005) reported that over a wide variety of countries from 1942-
2003 the prevalence of varicose veins varied from 2% to 56% in men and from <1% 
to 73% in women. However, in 2017 a decrease was reported that prevalence of CVI 
varied from <1% to 40% in women and from <1% to 17% in men3. CVI impacts 
countries financial status as wound care alone in the United States allots for 3 billion 
dollars annually3. 
There are many factors that put individuals at risk for the development of chronic 
venous insufficiency, such as, advancing age, family history of venous disease, 
ligament laxity, prolonged standing, increased BMI, smoking, sedentary life style, 
lower-extremity trauma, prior venous thrombosis, the presence of an arteriovenous 
shunt, some hereditary conditions, high levels of estrogen and pregnancy1,5,6,7-20.  

 
 
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Once diagnosed, treatment for CVI is a conservative management by reducing 
symptoms and preventing progress of the disease and secondary complications21. 
Initial conservative treatments consist of leg elevation, exercise therapy and 
compression to improve oxygen transport to the skin and subcutaneous tissues, 
decrease edema, reduce inflammation, and compress any dilated veins22. It is 
recommended that individuals with CVI maintain an ideal body weight or reduce their 
weight, if overweight, and maintain an overall healthy lifestyle19. Exercise is a 
recommended form of therapy for individuals with CVI as it can help improved calf 
muscle pump function23.  
In a clinical setting CVI is diagnosed through the use of the CEAP classification. 
The CEAP scoring is made up of four clinical components, (C)clinical signs, 
(E)Etiology, (A) Anatomy and (P)Pathophysiology. Each component of the CEAP 
classification have numerical subcomponents of their own. Within the clinical settings 
there are eight subcomponents, (C0) no visible or palpable signs of venous disease, 
(C1) telangiectasia/reticular veins, (C2) varicose veins, (C3) edema, (C4) 
Pigmentation or eczema, (C5) healed venous ulcer, (C6) active venous ulcer24. In 
the etiology there are four subcomponents, (Ec) congenital, (Es) secondary, (En) 
etiology not specified24. The anatomy component of the CEAP classification is 
broken down into four subcomponents, superficial venous system (As), perforating 
veins (Ap), deep venous system (Ad) and anatomy not specified (An) 24. The 
pathophysiology component is made up of four subcomponents, venous reflux (Pr), 
venous obstruction (Po), venous reflux and obstruction (Pr,o) and reflux not specified 
(Pn) 24. 
In regards to this study a CEAP score of C2, C3 and C4 will be included within 
the inclusion criteria. The C2 clinical classification is identified as varicose veins 
which are subcutaneous dilated veins 3mm or more. Edema or C3 is common 
among individuals with chronic venous insufficiency due to the increased volume of 
fluid in the skin and subcutaneous tissues, venous edema is commonly found in the 
ankle24. C4 is divided into two categories, C4a is known as pigmentation or eczema 
where the skin will have a brown/darkening pigmentation due to the hemosiderin 
deposition a result from the discharge of red blood cells typically occurring in the 
ankle region24.  Eczema is typically located near the varicose veins and begins as an 
erythematous dermatitis and has the potential to progress as blisters24.  C4b or 

 
 
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lipodermatosclerosis (LDS) is localized chronic inflammation and fibrosis of the skin 
and subcutaneous tissue of the lower extremities24. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2. STUDY RATIONALE 
Compression leg garments have become the mainstay for conservative 
management of CVI. It was found that treatment with a 30-to 40-mmgHg 
compression stocking results in improvement in pain, swelling, skin pigmentation, 
activity and well-being if compliance of 70%-80% is acheived21. Compression 
therapy is the first line of treatment that is implemented for individuals with chronic 
venous insufficiency21.  Individuals with CVI face a number of complications, such 
as, muscular dysfunction, limited ankle range of motion(ROM) and diminished calf 

 
 
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muscle pump function23. Exercise therapy has been shown to improve calf muscle 
pump function and  symptoms and may provide additional therapeutic benefits23.  It 
has been reported that structured exercise has the ability to improve ankle joint 
range of motion, calf muscle strength and calf muscle pump function. However, the 
majority of structured exercise programmes strictly focus on the lower trunk and 
lower leg strengthening. Focusing on one aspect of the body only when participating 
in structured exercise has the potential to be harming to an individual’s kinetic chain 
and posture. A combination of upper and lower body structured exercise as well as, 
ankle join range of motion and a walking regimen has the potential to have a 
significant impact on an individual’s calf muscle pump function and avoid these 
potentially harmful side effects of lower body exercise programmes 
 
Structured Exercise and Calf Muscle Pump Function in CVI 
Padberg, Johnston and Sisto (2004) conducted a study hypothesising that 
structured exercise would improve calf muscle pump function, calf muscle strength 
and venous hemodynamic in patients with chronic venous insufficiency. All patients 
were clinically diagnosed with advanced CVI and a CEAP score of 4,5,6 all 
determined through a duplex ultrasound scanning23. Patients with an ulceration 
greater than 4 cm in diameter, painful ulceration, active local infection, recognized 
noncompliance, absence of objective evidence of a venous cause, uncompensated 
cardiorespiratory insufficiency, ABI less than 0.7, and recent venous thrombosis 
were excluded from the study23. A total of 77 patients were screened for the study, 
46 participants were excluded, there was a total of 30 trial subjects and a total of 28 
participant data was analysed23.   
Patients underwent air plethysmography (APG)  to evaluate reflux volume, 
outflow, and calf pump function as well as ankle isokinetic dynamometer. 
Investigators used a Biodex System 2 multi-joint and rehabilitation system to obtain 
data for calf torque, work, power and range of motion23. Ankle plantar flexion and 
extension were tested on the Biodex twice, one week apart at two separate speeds, 
slow (60 degrees per second) with full ankle dorsiflexion and fast (120 degrees per 
second) with full ankle plantar flexion23. All patients completed five repetitions at the 
slow speed and fifteen repetitions at the fast speed, all tests were replicated from 
Sisto et al and Holback et al23. Measurements collected were the average of all 

 
 
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contractions for peak torque, peak torque per unit of body weight, maximal repetition 
work, total work, average power, and maximal range of motion23. All patients 
underwent functional and quality of life assessment through the administration of the 
Aberdeen Varicose Vein Survey, CIVIQ, the physical function terms of the SF-36 
Health Survey, the functional independence measure, Craig Handicap and reporting 
techniques, and older American resources to test for function in daily life23. All 
questionnaires were administered at 0 (baseline) and 6-months (completion of the 
study) 23. Participants were then randomly allocated into two unblinded groups; the 
control group or the therapy (experimental) group.. 
Participants randomized into the exercise prescription group received 3-
months of supervised exercise therapy followed by 3-months of unsupervised 
exercise therapy. At baseline, 3 months and 6 months clinical examinations, APG, 
and isokinetic dynamometry were performed23. The supervised exercise programme 
consisted of lower limb and trunk stretching and strengthening, active gravity 
strengthening and resistance weights in two session each week each lasting for 
approximately one hour23. All exercise programmes and prescriptions were 
individualized by the physiotherapist. Exercise training focused on the strengthening 
of lower leg, specifically, calf musculature and progression was monitored by 
repetitions, sets and weights throughout the duration of the exercise programme. In 
each session uphill treadmill walking was incorporated in the supervised training 
programme and participants were encouraged to continue uphill walking in the final 
3-months of unsupervised exercise training. Compliance to the exercise programme 
was documented by the number of days the participants attended the supervised 
exercise sessions and in the unsupervised exercise phase the number of days of 
exercise completed or not23. Patients in the usual care control group underwent 
baseline measurements at 0 and again at 6 months. The control group was 
monitored monthly to confirm and ensure participants were using their compression 
stockings23. Upon completion of the 6-month programme participants in the control 
group had the opportunity to take on the 6-month supervised exercise therapy as 
wait-listed participants23. 
Padberg, Johnston and Sisto (2004) compared the experimental group with 
the control group and found that the ejection fraction (EF) increased significantly 
(P<.026) and the residual volume fraction (RVF) decreased significantly (P<.029)23. 

 
 
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After 6-months it was reported that there was no significant change in venous clinical 
severity score and outflow fraction or obstruction23.  When compared to the control 
group, the exercise group improved their mean peak torque per unit body weight as 
well as slow and fast peak torque23.  A univariate ANOVA was perfomed controlling 
baseline values found a difference for slow speeds (P<.053) and fast speeds 
(P<.033) 23.   However, when compared at 6-months there was no significant 
difference between the two groups for other Biodex measurements23. Between the 
two groups there were no significant differences observed in QOL, functional or 
perceived impairment23. The structured exercise group experienced improved calf 
muscle pump function and dynamic calf muscle strength after 6-months23. Calf 
muscle strength was improved at both speeds slow and fast when normalized to 
body weight23. Padberg, Johnston and Sisto (2004) stated that direct physical 
conditioning of the calf musculature may prove beneficial for patients with or without 
alternative management options for severe CVI. 
The primary limitation faced in this study was the low number recruited to the 
study, 30 instead of planned  60, which was the target number of participants. Within 
the two individual groups there were limitations of their own; there was a 
nonsignificant pattern of greater medical comorbidity and greater musculoskeletal 
complications in the experimental group23. From the research conducted it is 
suggested to have a greater sample size and a multisite study to confirm and clarify 
the effects of physical therapy on CVI, the effects on QOL, and benefit for the 
particiapants23. 
 
Effects of isokinetic on calf musculature in patients with CVI 
  
Ercan et al (2017) conducted a study observing the change of ankle joint 
range of motion, muscle strength values of plantar flexion and dorsiflexion measured 
with an isokinetic dynamometer, Visual Analog Scale (VAS) scored, EQ-5D quality of 
life scale, and venous return time in individuals clinically diagnosed with CVI after a 
12-week exercise intervention29. There was a total of 27 patients included in the 
study, 23 female and 4 male, five patients left the study due to inadequate 
compliance with the exercise programme as a result 22 patients were included in a 
statistical analysis29.   

 
 
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All patients were diagnosed with a CEAP 3 and 4 determined by the patients’ 
medical history and findings from a physical examination, Doppler ultrasonography 
and photo-plethysmography (PPG) testing29.  Patients with painful ulcer venous 
ulceration, active local infections, the patient incompatibility during the test, non-
compensatory heart and lung failure, peripheral arterial disease, diabetes, 
vasodilator treatment, orthopaedic disorders of the ankle, and any systemic disease 
were excluded29. Before and after the 12-week exercise programme all patients had 
their ankle joint range of motion assessed, quality of life and PPG testing all baseline 
measurements were employed in the same order29.  
The structured exercise programme consisted of an isokinetic exercises for 
the calf musculature for three days a week for 12-weeks29. The exercise programme 
was made up of range of motion exercises (10 reps X 3 sets), thera-band exercises 
(10 reps X 3 sets, flexion-extension-internal and external rotation), isokinetic 
exercise (three different speeds 60, 90, 120 for 10 repetitions for 3 sets), stability 
exercise on balance board (10-minutes), treadmill walking (60% HR max for 20-
minutes), intermittent pneumatic compression (JOBST for 20-minutes) 29. Ankle 
plantar flexion and dorsiflexion were tested at speeds of 60-120/s in 
concentric/concentric mode all tests were applied in a prone position at a range of 
motion of 15 dorsiflexion and 40 plantarflexion29.  
PPG measurements for all patients included in the study were conducted by a 
cardiovascular surgeon. VAS scoring was used to determine the severity of the 
patients CVI and the EQ-5D quality of life survey was used to understand the effect 
CVI has on the individuals quality of life29. Ankle joint range of motion measurements 
were measured by a metal goniometer prior to isokinetic muscle strength 
measurements29. Before participating in the muscle strength test patients underwent 
submaximal warming exercises on the cycle ergometer for 10 minutes, followed by 
stretching exercises for five minutes29. Peak torque and total work values of ankle 
plantar flexion and dorsiflexion were measured by isokinetic testing29. 
As mentioned there were 27 patients included in the study; at the end of 12-
weeks five patients were excluded due to inadequate compliance to the exercise 
programme leaving 22 patients for statistical analysis. An dependent t-test was 
performed found a significant increase (p<0.05)  in the participants venous return 
times (VRT) 29.  Ankle ROM increased significantly (p<0.05) as well as an increase in 

 
 
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peak torque (PT), PT/BW, total work done in PF and DF and a significant decrease 
in agonist/antagonist ratio through isokinetic measurement (p<0.05) 29. Ercan et al 
(2017) found that the 12-week at home exercise programme decreased participants 
VAS values and a significant increase in EQ-5D quality of life scale(p<0.05) 29. 
However, the study failed to positively impact participants calf muscle pump function 
in regards to venous reflux. After 12-weeks of structured calf muscle exercise 
participants experienced improved ankle ROM, improved muscular strength, overall 
improved QOL, improved VRT and reduction of pain29. After 12-weeks of structured 
exercise it was reported, exercise has a positive impact in the treatment of venous 
insufficiency29. 
Isokinetic testing is necessary and highly beneficial when evaluating muscle 
performance. Measurements are obtained by the machine performing kinematic 
analysis of movements and comparing both sides of the extremity through 
agonist/antagonist muscle strength and the work capacity and endurance of muscle 
movement29. Manual muscle testing does not provide accurate and reliable values, 
this form of testing only establishes the force which occurs at a certain point of 
movement. Data such as work, force, and endurance are immeasurable, it was 
reported a 23%-31% deficit was found in isokinetic knee testing in patients who 
reportedly had normal values in manual testing29. Isokinetic testing is a 
musculoskeletal performance system that has the ability to compute reliable 
quantitative data and provide the option to save the patients data to evaluate the 
disease progression or improvement29. Isokinetic testing is highly beneficial to this 
study and patient population as it assists in the evaluation of muscular strength in 
which can aid in the improvement of calf muscle pump function and ankle ROM 
which can also contribute to the improvement of calf muscle pump function in 
individuals with CVI. 
Adequate ROM is as important in healthy individuals as it is in individuals with 
CVI. With long periods of inactivity muscles tend to shorten, resulting in tightness of 
the muscle. ROM is then negative affected by these tight muscles restricting the joint 
from reaching the full range. Ercan et al (2017) stated that the slightest change in 
ROM has the potential for greater hemodynamic changes. It is reported that a 
change of 1.5 cm  in ankle rotation axis leads to 8.3% increase in extension PT30. 
There is a positive correlation between an individual with CVI and their ROM and the 

 
 
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stage of venous disease they may be experiencig31. It is recommended for 
individuals with CVI to incorporate ankle exercises into their daily lives as they can 
be highly beneficial to ROM improvement and calf muscle contracion29. 
It is important for individuals participating in a new exercise intervention that 
the exercise technician incorporates all movements that an individual will experience 
in a day, such as, bending and lifting, single leg movements, pushing, pulling and 
rotation. Both studies discussed did not incorporate an upper-body movement or 
intervention. An exercise intervention should include all the daily movements 
mentioned above it and it should also include the appropriate open-chain and close-
chain movements to ensure the body is moving and growing in unison. By 
incorporating upper and lower body exercises, aerobic exercise and range of motion 
into an exercise programme the individual will receive a well balance approach to 
exercise and maintain proper posture and  alignment within their kinetic chain.  
 The “Strength From Within” (SFW) programme incorporates upper and lower 
body exercise both assisted and non-assisted as well as open-chain and closed-
chain movements. This is a 12-week at home based structured resistance exercise 
programme which has the ability to be modified to different exercise intensities and 
individual abilities. Participants will have the choice of how many repetitions they 
complete for each exercise, if they need to be sitting or standing for certain exercises 
and when in their day they want to complete the exercises. The SFW programme 
consists of a total of twenty exercises made up of upper and lower body exercises 
both sitting and standing. Participants will be asked to complete lower body 
exercises on Monday, Wednesday and Friday and upper body exercises Tuesday, 
Thursday and Saturday and Sunday as a rest and recovery day. Incorporated with 
resistance programme are ankle ROM exercises, a warm-up and cool-down, and a 
walking protocol. This exercise intervention is a full body at home resistance and 
aerobic programme that has the potential to improve calf muscle pump function, 
venous clinical severity score, calf muscle strength, greater ankle range of motion, 
overall physical strength and quality of life. 
 
 
 
 

 
 
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3. STUDY HYPOTHESIS 
Implementation of a 12-week at home structured exercise and aerobic programme 
will produce physiological and psychological benefits in individuals with chronic 
venous insufficiency. 
 
 
 
 

 
 
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4. STUDY DESIGN 
 
Feasibility Study; Cohort Prospective 
 
 
 
 
 

 
 
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5. STUDY OBJECTIVES 
Following the terms of PICO (Population; Intervention; Comparator; Outcome) the 
primary research question for this trial is: in adult patients with chronic venous 
insufficiency can a 12-week at home structured exercise and aerobic programme 
improve calf muscle pump function, venous clinical severity score, calf muscle 
strength, greater ankle range of motion, overall physical strength and quality of life. 
 
5.1 Research Aim To determine the feasibility of a 12-week at home structured 
resistance and aerobic exercise programme.  
 
5.2 Research Objectives 
i. 
To determine if structured exercise results in improves calf muscle pump 
function and the magnitude of change in calf muscle pump function 
ii. 
To determine if structured exercise results in improved venous clinical severity 
score and, if so, the percentage of participants who achieve an improved 
score.  
iii. 
To determine if structured exercise results in increased calf muscle strength 
and the magnitude and range of same and the percentage of participants who 
achieve an improved score.   
iv. 
To determine if structured exercise results in improved ankle range of motion 
and the magnitude and range of change between time 0 and at end of study.  
v. 
To determine the response rate and completion rate of participants 
vi. 
Time needed to collect measurements 
vii. 
Time needed to instruct participants in exercises of “strength from within” 
programme and provide individualised plan for participants.  
viii. 
Time per week of phone contact. 
ix. 
Adherence to weekly exercise regimen in terms of days per weeks, duration 
per day and number and type of exercises completed per day. To determine if 
structured exercise results in increased overall physical strength 
x. 
To determine if structured exercise results in improved quality of life 
 
 
 
6. STUDY DESIGN 

 
 
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6.1 Statement of Design 
A feasibility study on the effect of a 12-week at home structured resistance and 
aerobic exercise programme in individuals with chronic venous insufficiency.  
 
6.2 Study Procedure 
There will be a total of sixty participants recruited for the study, with an 
anticipation of 40 to complete the study. Participants will complete the Physical 
Activity Readiness Questionnaire (PAR-Q) to ensure that they are able to participate 
in the structured exercise programme. If the participants’ answers “yes” to any 
question on the Physical Activity Readiness Questionnaire (PAR-Q), he/she is 
ineligible to participate. Participants will also read a participant information leaflet and 
sign an informed consent before participating in the study. Baseline demographic will 
be collected at the start of the study. Participants will complete the SF-36 Health 
Survey at session one and session 2 (week 12). Baseline testing will be conducted. 
The following measures will be employed in the study through a baseline testing and 
repeated at the end of the study period (week 12): Functional ambulatory 
measurements, physical activity measurements, isokinetic testing, duplex ultrasound 
screening. 
Upon completing baseline testing participants will have the warm-up, cool-
down, stretches, all exercise demonstrated and explained to them. Participants will 
go through each exercise with the principal investigator to ensure understanding. 
The principal investigator will then describe each section of the “Strength From 
Within” Booklet. At the end of the first session the participants will be administered 
their at home structured exercise booklet, recording booklet, resistance band, warm-
up and cool-down information sheet and their ankle range of motion information 
sheet. 
The baseline meeting and the week 12 meeting will take roughly 90 minutes 
to complete all baseline measurements, questionnaires, isokinetic testing and 
demonstrations. Isokinetic testing will take a total of 32 minutes with resting periods 
included in the time, baseline measurements including the muscle strength and 
functional ambulatory measurements will take a duration of 10.5 minutes, 
demonstration of the home structured exercise programme will take up to 20 
minutes, both questionnaires will take 5-minutes total and time left for any other 

 
 
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questions or concerns. Extra time will be given at any point during both meetings if 
needed by the participant. 
 
6.3 Selection of Participants 
Participants will be screened by Professor Sherif Sultan at his vascular clinic using 
the inclusion/exclusion criteria. 
 
6.4 Participant Recruitment 
Through the vascular clinic of Professor Sherif Sultan at Galway Clinic Hospital. 
Professor Sherif Sultan will screen the patients with the inclusion and exclusion 
criteria. Once patients are screened and eligible for recruitment and expressed 
interest in being contacted by study researcher, with their permission Professor 
Sherif Sultan will provide their contact information to the study researcher, who will 
then contact the patient to arrange meet at a time convenient to the patient. At that 
meeting, the patient will receive the PIL to read. Any questions will be answered by 
the study researcher. If the patient wishes to participant he/she will sign 2 copies of 
the consent form, which will also be signed by the study researcher. A signed copy 
of the consent form will be given to the participant along with the PIL. 
 
 6.5Inclusion Criteria 
 Adult patients with chronic venous insufficiency and a CEAP Score of 2,3,4. 
 
6.6 Exclusion Criteria 
i. 
Younger than 18 years 
ii. 
Painful Ulceration 
iii. 
Severe Cardiac Condition 
iv. 
Cardiorespiratory Disease 
v. 
Failure of Physical Activity Readiness form 
vi. 
ACSM Risk Classification: Class C or above 
vii. 
CEAP classification of 5 or 6 
viii. 
Severe mobility impairment 
ix. 
Severe imbalance 
x. 
Women who are pregnant 

 
 
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xi. 
Women who are breastfeeding 
xii. 
Those who lack capacity to consent 
xiii. 
Those for whom English is not the first language and have difficulty 
understanding written and/or spoken English  
xiv. 
Diagnosis of diabetes 
xv. 
Diagnosis of peripheral arterial disease 
xvi. 
Diagnosis of peripheral neuropathy 
 
6.7 Selection of Patients 
Patients will be recruited from vascular surgery clinic at Galway Clinic Hospital 
 
6.8 Informed Consent 
An informed consent will be provided to the patients and will be signed and obtained 
by both the investigator and the participant. Consent to participate in the trial will be 
obtain from each patient after full explanation and consideration of the trial. A copy of 
the signed consent form will be given to the participant and a copy will be kept 
secure by principal investigators. Participants will also be given a written information 
sheet about the study. It is the individuals’ right to withdraw from the trial at any point 
without reason. The informed consent will meet and withhold principals and 
requirements of the approving research ethics committee. 
 
Informed consent for patients 
Following verbal explanation of the study possible participants will be given time 
within the first meeting to consider participation. If the participant requests more time 
to consider participation then they will ask to contact the study researcher whose 
contact details are on the PIL at a time that suits them to either answer any further 
queries, agree to participate or otherwise. If they decide they do not want to 
participate then it will not be necessary to contact the study researcher unless they 
wish to do so. It is anticipated that most eligible patients who agree to meet will 
decide at the initial meeting if they wish to participate and there will be no time 
restriction at this meeting to decide to participate or otherwise. As per consent form it 
will be very clear to the eligible patient that if they decide not to participate this will 
not affect any aspect of their ongoing treatment under Professor Sherif Sultan. 

 
 
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6.9 Baseline Data 
All participants will undergo a limited medical history as well as functional ambulatory 
and physical activity measurements. All baseline measurements in the first session 
and second session will take roughly 90 minutes. This includes isokinetic testing (32 
minutes), muscle strength measurements and functional ambulatory measurements 
(10.5 minutes), demonstration of at home structured exercise programme (up to 20 
minutes) and five minutes for both questionnaires.  
The following measures will be recorded: 
1. Gender 
2. Date of birth 
3. Calf Muscle Pump Function 
4. Venous Clinical Severity Score 
5. Physical Activity Readiness Questionnaire(PAR-Q) 
6. SF-36 Short Form Health Survey 
7. Calf Torque 
8. Calf Work 
9. Calf Power 
10. Plantarflexion Range of Motion 
11. Dorsiflexion Range of Motion 
12. 6-Minute Walk Test 
13. Right Single Leg Balance 
14. Left Single Leg Balance 
15. Sit-to-Stand 
16. Step-Overs 
17. Right Single Arm Bicep Curl 
18. Left Single Arm Bicep Curl 
19. Right Single Arm Triceps Extension 
20. Left Single Arm Triceps Extension 
21. Push Press 
 
6.10 Physical Activity Readiness Questionnaire (PAR-Q) 

 
 
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All patients will complete a Physical Activity Readiness Questionnaire (PAR-Q) prior 
to participating in the trial. The PAR-Q is designed to determine if physical activity is 
safe for individuals or if they may need medical clearance from a physician. If a 
patient fails to complete or pass the PAR-Q they will be ineligible for participation in 
the trial.  
 
6.11 SF-36 Short Form Health Survey 
All patients will complete the SF-36 Short Form Health Survey at baseline and at the 
completion of the 12-week exercise programme. The SF-36 Short Form Health 
Survey is utilized to evaluate an individual’s quality of life.  
 
6.12 Venous Clinical Severity Score 
All patients will complete the Venous Clinical Severity Score at baseline and upon 
completion of the 12-week study. The Venous Clinical Severity Score will be used to 
characterized the severity of the patients’ chronic venous insufficiency and to monitor 
any progression made. 
 
 6.13 Calf Muscle Pump Function: Duplex Ultrasound Scanning 
All patients will undergo a comprehensive duplex ultrasound scanning to determine 
the nature and extent of venous reflux. The duplex ultrasound will be conducted by 
Professor Sherif Sultan during a clinical appointment. A repeat of objective 
measures will be repeated at the completion of their 12-week. 
 
6.14 Biodex Measurements-Isokinetic Testing 
All patients will undergo lower limb isokinetic (concentric/concentric) testing using a 
using a Biodex Multi-joint System33,34. All Biodex testing will be conducted based of 
evidence based clinical protocols provided by Biodex. Biodex measurements will 
consist of knee flexion/extension and ankle plantar flexion and dorsiflexion. For knee 
flexion/extension patients will undergo a bilateral isokinetic 3 speed evaluation to 
establish goals and monitor progress33. Patients will move through full range of 
motion with a percent range of 100 and will be evaluated at three speeds and three 
repetitions33. At 60/second the patient will complete 5 repetitions, at 180/ seconds 
the patient will complete 10 repetitions and at 300/second the patient will complete 

 
 
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15 repetitions33. Ankle plantar flexion and dorsiflexion will be measured with a 
bilateral isokinetic 2 speed evaluation at 5 repetitions at 60/second and 10 at 
120/second34. Testing will be administered at baseline and at the completion of the 
12-week exercise programme; data will be collected and recorded on calf torque, calf 
work, calf power, plantarflexion range of motion and dorsiflexion range of motion. 
 
6.15 Functional Ambulatory Measurements: 
 6-minute walk test: All patients will complete a 6-minute walk test on an 
even/flat 25m ground supervised by a trained exercise technician. Participants will 
be instructed to walk for 6 minutes at a moderate comfortable rate. 
 
6.16 Physical Activity Measurements 
Muscle Endurance Testing 
All patients will complete muscular endurance for all major muscles. Patients will be 
asked to complete a series of upper and lower body exercises testing their muscular 
endurance within 30 seconds. All patients will complete as many repetitions as they 
can in 30 seconds at a speed they are comfortable preforming at. Muscular 
endurance testing will be conducted at baseline and upon the completion of the 12-
week structured exercise programme. The muscular endurance testing consists of 
single leg balance on each leg, step overs, sit to stand, push press, single arm right 
bicep curl, single arm left bicep curl, and single arm right triceps extension and single 
arm left triceps extension at a moderate rate or intensity. 
 
 
 
6.17 Strength From Within Exercise Programme 
- All patients will receive the structured exercise programme, and the 
“Strength From Within Booklet”, a resistance band, a recording booklet, a walking 
information leaflet, ankle range of motion exercises, a warm-up and a cool-down. 
The Strength From Within booklet provides a descriptive linguistic and visual 
demonstration of proper technique and safety for all exercises. The at home 
resistance exercise programme consists of a total of twenty standing and sitting 
exercises divided into upper and lower body.  Patients will participate in the Strength 

 
 
21
From Within structured exercise programme for 12-weeks by choosing their own 5 
upper body exercise and 5 lower body exercise per week from the Strength From 
Within booklet.  Patients are able to have a combination of standing and sitting 
exercises to accommodate their ambulatory needs. Patients will complete lower 
body exercises on Monday, Wednesday and Friday and complete upper body 
exercises Tuesday, Thursday and Saturday; Sunday is a rest and recovery day. To 
further the individualistic aspect of the programme patients will be deciding their own 
repetitions from a range of eight to twelve, however, the exercise technician will be 
contacting the patients each week to monitor and implement repetition progression. 
Progression will be implemented if the patient is able to complete two full weeks of 
the same repetition count. Built into the exercise programme there will be a dynamic 
warm-up and static-stretching cooldown, both lasting for five minutes. Ankle range of 
motion exercises using the resistance band will be included in the exercise 
programme to be completed on Monday, Wednesday and Friday. Patients will be 
completing three sets of ten ankle dorsiflexion and plantarflexion with a resistance 
band. All exercise will be demonstrated and practiced with participants to ensure 
proper technique and safety. In combination with the Strength From Within 
programme, patients will participate in a 12-week walking protocol. Each walking 
protocol will be individualized at the first meeting following the 6-minue walk test. 
Patients’ walking progression will be determined biweekly based on the patients’ 
experience and response to the protocol. Patients will receive a walking protocol 
recording sheet to fill in the minutes walked each day and the total duration each 
week. The exercise technician will be referring to the Mayo Clinic 12-week walking 
protocol for guidance. 
Participants will be contacted each week by telephone or personal interaction. 
Regular weekly check in will be done to know the improvement and status of the 
participant and to possibly adjust the repetitions and sets to be completed that week 
accordingly. Upon completion of the study participants will be contacted 3-months 
after their completion date. Participants will be contacted be telephone and be asked 
to participate in a short questionnaire on their adherence to the exercise programme 
after their 12-weeks finished. At the 12-week meeting the study researcher will 
collect the participants recording booklet in order to evaluate and measure 
adherence/compliance to the structured exercise programme. Participants have the 

 
 
22
right to deny participation in the follow-up questionnaire, if they wish to do so 
appropriate documentation will be completed to ensure missing data is accounted 
for. If the study researcher cannot get in touch with the participant on the first attempt 
to contact the study researcher will call once more a week later. If the study 
researcher cannot get in contact with the participant after the second attempt the 
study researcher will not contact that participant again 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7. TRIAL OUTCOMES MEASURES 
 
7.1 Primary Outcome Measures 
This trial was to determine the effect of a 12-week at home structured exercise and 
aerobic programme in patients with chronic venous insufficiency. The primary 
outcome measures is the effect a 12-week at home structured exercise and aerobic 
programme has on muscle pump function, venous clinical severity score and calf 
muscle strength in an individuals with chronic venous insufficiency. 
 
7.2 Secondary Endpoints 

 
 
23
The following endpoints will be measured: 
1.  Ankle Joint Range of Motion 
2. Overall physical strength 
3. Exercise Capacity 
4. Quality of life 
 
8 TRIAL OUTCOME ASSESSMENT 
Trial outcomes will be recorded on a baseline measurement form developed by the 
supervising exercise technician. 
 
8.1 Evaluation of Other Primary and Secondary Outcomes 
Remaining primary and secondary outcomes will be determined by the blinded trail 
assessor through data collected. 
 
 
 
10 STATISTICAL APPROACH 
Graphical and numerical summaries will be provided for all response variables 
of interest. For categorical variables, test of association will be performed to test for 
any associated between factors of interests. Chi squared test (using a significance 
level of 0.05) will be used if the underlying assumption relating to the expected values 
are deemed appropriate, otherwise Fisher Exact Test will be employed. For binary 
variables, comparisons of proportion based on the Normal approximation of the 
Binomial distribution will be used as necessary. P-values will be reported for those 
comparisons of specific interest as opposed to comparing all levels of all variables. 
And post intervention scores will be compared. Baseline characteristics of the 
participants and physical activity levels will be compared from week one of the study, 
to week 12 the completion of the study. Duration of the obtaining baseline data and 
final data will be measured. An ANVOA will be performed to analyse change over time. 
The outcomes will be found by using a paired t test. Mean baseline values will be 
computed from both duplex ultrasound screening and Biodex. Treatment effects will 
be estimated by an analysis variance (ANOVA).  
 

 
 
24
11 SAMPLE SIZE 
The primary outcome for this trial is the effect a 12-week at home structured 
resistance and aerobic exercise programme has on muscle pump function, venous 
clinical severity score and calf muscle strength in an individuals with chronic venous 
insufficiency. Research suggest that participation in a structured exercise 
programme has the ability to improve calf muscle pump function and dynamic calf 
strength23,29. As a pilot study 60 participants will be recruited; with intention of 30 
participants completing the trial; previous pilot studies conducted similar to this trial 
have used similar sample size. 
 
 
 
 
 
 
 
 
References 
1. Beebe-Dimmer J, Pfeifer J, Engle J, Schottenfeld D. The Epidemiology of Chronic 
Venous Insufficiency and Varicose Veins. Annals of Epidemiology. 
2005;15(3):175-184. doi:10.1016/j.annepidem.2004.05.015. 
2. O'Donovan K, Bajd T, Grace P, O'Keeffe D, Lyons G. Preliminary Evaluation of 
Recommended Airline Exercises for Optimal Calf Muscle Pump Activity. EJVES 
Extra. 2006;12(1):1-5. doi:10.1016/j.ejvsextra.2006.04.001. 
3. Dua A, Heller J. Advanced Chronic Venous Insufficiency. Vascular and 
Endovascular Surgery. 2017;51(1):12-16. doi:10.1177/1538574416682175. 
4. White-Chu E, Conner-Kerr T. Overview of guidelines for the prevention and 
treatment of venous leg ulcers: a US perspective. Journal of Multidisciplinary 
Healthcare. 2014:111. doi:10.2147/jmdh.s38616. 
5. Brand F, Dannenberg A, Abbott R, Kannel W. The epidemiology of varicose veins: 
the Framingham Study. American Journal of Preventative Medicine. 
1998;4(2):96. 

 
 
25
6. Callam M. Epidemiology of varicose veins. British Journal of Surgery. 
1994;81(2):167-173. doi:10.1002/bjs.1800810204. 
7. Chiesa R, Marone E, Limoni C, Volontè M, Petrini O. Chronic venous disorders: 
Correlation between visible signs, symptoms, and presence of functional 
disease. Journal of Vascular Surgery. 2007;46(2):322-330. 
doi:10.1016/j.jvs.2007.04.030. 
8. Scott T, LaMorte W, Gorin D, Menzoian J. Risk factors for chronic venous 
insufficiency: A dual case-control study. Journal of Vascular Surgery. 
1995;22(5):622-628. doi:10.1016/s0741-5214(95)70050-1. 
9. Fowkes F, Lee A, Evans C, Allan P, Bradbury A, Ruckley C. Lifestyle risk factors 
for lower limb venous reflux in the general population: Edinburgh Vein Study. 
International Journal of Epidemiology. 2001;30(4):846-852. 
doi:10.1093/ije/30.4.846. 
10. SADICK N. Predisposing Factors of Varicose and Telangiectatic Leg Veins. The 
Journal of Dermatologic Surgery and Oncology. 1992;18(10):883-886. 
doi:10.1111/j.1524-4725.1992.tb02921.x. 
11. Iannuzzi A, Panico S, Ciardullo A et al. Varicose veins of the lower limbs and 
venous capacitance in postmenopausal women: Relationship with obesity. 
Journal of Vascular Surgery. 2002;36(5):965-968. 
doi:10.1067/mva.2002.128315. 
12. Evans C, Fowkes F, Hajivassiliou C, Harper D, Ruckley C. Epidemiology of 
varicose veins. A review. The International Journal of Angiology. 
1994;13(3):263. 
13. Browse N. The etiology of venous ulceration. World Journal of Surgery. 
1986;10(6):938-943. doi:10.1007/bf01658644. 
14. Browse N, Burnand K. CAUSE OF VENOUS ULCERATION. The Lancet. 
1982;320(8304):932. doi:10.1016/s0140-6736(82)90901-1. 

 
 
26
15. Darvall K, Sam R, Adam D, Silverman S, Fegan C, Bradbury A. Higher 
prevalence of thrombophilia in patients with varicose veins and venous ulcers 
than controls. Journal of Vascular Surgery. 2009;49(5):1235-1241. 
doi:10.1016/j.jvs.2008.12.017. 
16. ALLISON M, CUSHMAN M, CALLAS P, DENENBERG J, JENSKY N, CRIQUI 
M. Adipokines are associated with lower extremity venous disease: the San 
Diego population study. Journal of Thrombosis and Haemostasis. 
2010;8(9):1912-1918. doi:10.1111/j.1538-7836.2010.03941.x. 
17. Serra R, Buffone G, de Franciscis A et al. A Genetic Study of Chronic Venous 
Insufficiency. Annals of Vascular Surgery. 2012;26(5):636-642. 
doi:10.1016/j.avsg.2011.11.036. 
18. Anwar M, Georgiadis K, Shalhoub J, Lim C, Gohel M, Davies A. A Review of 
Familial, Genetic, and Congenital Aspects of Primary Varicose Vein Disease. 
Circulation: Cardiovascular Genetics. 2012;5(4):460-466. 
doi:10.1161/circgenetics.112.963439. 
19. Vlajinac H, Radak D, Marinkovic J, Maksimovic M. Risk factors for chronic 
venous disease. Phlebology. 2012;27(8):416-422. 
doi:10.1258/phleb.2011.011091. 
20. Vlajinac H, Marinkovic J, Maksimovic M, Matic P, Radak D. Body Mass Index 
and Primary Chronic Venous Disease – A Cross-sectional Study. European 
Journal of Vascular and Endovascular Surgery. 2013;45(3):293-298. 
doi:10.1016/j.ejvs.2012.12.011. 
21. Gloviczki P, Comerota A, Dalsing M et al. The care of patients with varicose 
veins and associated chronic venous diseases: Clinical practice guidelines of 
the Society for Vascular Surgery and the American Venous Forum. Journal of 
Vascular Surgery. 2011;53(5):2S-48S. doi:10.1016/j.jvs.2011.01.079. 
22. O’Donnell T, Passman M, Marston W et al. Management of venous leg ulcers: 
Clinical practice guidelines of the Society for Vascular Surgery® and the 

 
 
27
American Venous Forum. Journal of Vascular Surgery. 2014;60(2):3S-59S. 
doi:10.1016/j.jvs.2014.04.049. 
23. Padberg F, Johnston M, Sisto S. Structured exercise improves calf muscle pump 
function in chronic venous insufficiency: a randomized trial. Journal of Vascular 
Surgery. 2004;39(1):79-87. doi:10.1016/j.jvs.2003.09.036. 
24. Eklof B, Perrin M, Delis K, Rutherford R, Gloviczki P. Updated terminology of 
chronic venous disorders: The VEIN-TERM transatlantic interdisciplinary 
consensus document. Journal of Vascular Surgery. 2009;49(2):498-501. 
doi:10.1016/j.jvs.2008.09.014 
25. Caggiati A, Bergan J, Gloviczki P, Jantet G, Wendell-Smith C, Partsch H. 
Nomenclature of the veins of the lower limbs: An international interdisciplinary 
consensus statement. Journal of Vascular Surgery. 2002;36(2):416-422. 
doi:10.1067/mva.2002.125847. 
26. Caggiati A, Bergan J, Gloviczki P, Eklof B, Allegra C, Partsch H. Nomenclature of 
the veins of the lower limb: Extensions, refinements, and clinical application. 
Journal of Vascular Surgery. 2005;41(4):719-724. doi:10.1016/j.jvs.2005.01.018. 
27. Eklöf, Rutherford, Bergan et al. Revision of the CEAP classification for chronic 
venous disorders: a consensus statement. Vasa. 2005;34(3):157-161. 
doi:10.1024/0301-1526.34.3.157. 
28. Cranley J, Krause R, Strasser E. Chronic venous insufficiency of the lower 
extremity.  1961;49(48). 
29. Ercan S, Çetin C, Yavuz T, Demir H, Atalay Y. Effects of isokinetic calf muscle 
exercise program on muscle strength and venous function in patients with 
chronic venous insufficiency. Phlebology: The Journal of Venous Disease. 
2017:026835551769540. doi:10.1177/0268355517695401. 
30. Andersen H. Reliability of isokinetic measurements of ankle dorsal and plantar 
flexors in normal subjects and in patients with peripheral neuropathy. Archives of 

 
 
28
Physical Medicine and Rehabilitation. 1996;77(3):265-268. doi:10.1016/s0003-
9993(96)90109-4. 
31. Dixy F, Brooke R, McCollum C. Venous disease is associated with an impaired 
range of ankle movement*. European Journal of Vascular and Endovascular 
Surgery. 2003;25(6):556-561. doi:10.1053/ejvs.2002.1885. 
32. Clarke Moloney M, Lyons G, Breen P, Burke P, Grace P. Haemodynamic Study 
Examining the Response of Venous Blood Flow to Electrical Stimulation of the 
Gastrocnemius Muscle in Patients with Chronic Venous Disease. European 
Journal of Vascular and Endovascular Surgery. 2006;31(3):300-305. 
doi:10.1016/j.ejvs.2005.08.003. 
33. Boyle M, Galway B, McLaughlin T et al. Evidence-Based Clinical Protocols: 3) 
Anterior Cruciate Ligament Injury & Reconstruction. New York; 2006:3-3. 
Available at: http://www.biodex.com/sites/default/files/900521anterior.pdf. 
34. Boyle M, Jacoby S, McLaughlin T et al. Evidence-Based Clinical Protocols 5) 
Lateral Ankle Sprains. New York; 2006:5-9. Available at: 
http://www.biodex.com/sites/default/files/900521lateral.pdf. 
35. Get walking with this 12-week walking schedule - Mayo Clinic. Mayo Clinic. 2017. 
Available at: http://www.mayoclinic.org/healthy-lifestyle/fitness/in-
depth/walking/art-20050972. 
 
 
 
 
 
 

 
 
29
 
 
 
 
 
 
Mayo Clinic 12 Week Walking Protocol35 
 
Week 
Minutes 
1 
5 minutes 
2 
7 minutes 
3 
9 minutes 
4 
11 minutes 
5 
13 minutes 
6 
15 minutes 
7 
18 minutes 
8 
20 minutes 
9 
23 minutes 
10 
26 minutes 
11 
28 minutes 
12 
30 minutes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
30
 
 
 
 
 
 
 
Warm-up: 5 minutes 
 
▪ March in place 20 times  
Step 1: Stand upright, (shoulders back, abs tightened, and no arch in 
the lower back)  
Step 2: Lift right leg, lower right leg; lift left leg, lower left leg   
  
 
  
  
  
▪ Arm circles both 10 each direction  
  
Step 1: Start by standing straight with your feet shoulder width apart. 
Arms should be straight out to the sides, so that your body forms a 
T.   
Step 2: Slowly start by making small circular motions with both arms 
on either side. After a few repetitions of small circles, enlarge your 
circles and do the same amount of reps.   
 
  
  
▪ Hip Rotation 10 each direction  
  
Step 1: Start by standing straight with your feet shoulder width apart. 
Place hands on your hips.  
Step 2: Begin to rotate your hips in a clockwise direction, then switch 
to counter-clock wise.  
 

 
 
31
 
▪ Side step with arms up 10 each direction  
  
Step 1: Start by standing straight with your feet together with a strong 
tall body.  
Step 2: Step out with your left foot and raise hands up as you step 
out. Then switch to stepping with your right foot.  
 
  
  
▪ Cross step cross arm 10 total  
  
Step 1: Start by standing straight with a wide stance and a slight bend 
at your knees.   
Arms should be out straight to the side so your body is forming a T.  
Step 2: Alternate legs and arms as you cross.  
 
  
  
▪ Heel to butt steps 10 each side  
  
Step 1: Holding onto a firm object have a slight bend at the knees 
while leaning forward.  
Step 2: Bend on knee at a time bringing your heel towards you 
backside.   
  
       
 
  
  

 
 
32
▪ March 20 times  
  
Step 1: Stand upright, (shoulders back, abs tightened, and no arch in 
the lower back)  
Step 2: Lift right leg, lower right leg; lift left leg, lower left leg     
         
 
  
 
 
Cool Down (2 sets 30 seconds each)  
  
▪ Quadriceps Stretch:  
Step 1: Stand up right with weight balance on left leg. Keep left foot 
pointing straight and the knee almost straight. To help with balance 
use a wall or firm object for assistance.  
Step 2: Bend the right knee; grasp the right foot and pull the heel 
backward.  
Step 3: At the same time push forward at the hips. Complete set and 
then perform stretch to the opposite leg.           
 
  
  
▪ Hamstring Stretch:  
Step 1: Stand upright with weight balanced on left leg. Bend at the 
right hip and place the right leg on firm object that is close to the same 
height as your hips.  
Step 2: Bend at the waist and reach for your toes and keep left leg 
straight. Complete set and then perform stretch to the opposite leg.  
 
  

 
 
33
 
 
 
  
▪ Inner Thigh Stretch:  
Step 1: Sit comfortably with your legs at a 90-degree angle and bent 
at the waist with your chest parallel to the floor.  
Step 2: As you lean forward use your elbows or forearms to cause a 
stretch in the inner thigh area. Complete set and then perform stretch 
to the opposite leg.  
  
 
  
  
▪ Bicep Stretch:  
Step 1: Extend one arm and flex the wrist at the same time. Use the 
opposing hand to grasp the fingers and pull the fingers toward the 
body. Complete set and then perform stretch to the opposite arm.  
 
  
▪ Triceps Stretch:  
  
Step 1:  Sit or stand upright with the left arm bent at the elbow. Raise 
the left arm until the elbow is next to the left ear and the left hand is 
near the right shoulder blade.  
Step 2: Grasp the left elbow with the right hand and pull or push the 
left elbow behind the head and toward the floor. Complete set and 
then perform stretch to the opposite arm.  
 
 
 
▪ Chest Stretch  

 
 
34
  
Step 1:  Stand upright while facing a doorway or corner. Place feet 
shoulder width apart with one foot slightly in front of the other.  
Step 2:  With straight arms, raise your arms to shoulder level and 
place the palms on the wall or doorframe with the thumbs on top. 
Lean your body forward, and complete set and then perform stretch to 
the opposite arm.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
35
 
Ankle Range of Motion Exercises 
3 Sets of 10 for each ankle 
3 days per-week 
Equipment: Resistance (elastic band) 
 
 
Plantarflexion 
Step 1: Sit on the floor or a bed with your back supported and your legs straight out 
in front of you 
Step 2: Wrap the resistance band around your foot and hold each end of the 
resistance band in your hands 
Step 3: Have your ankle held up towards your head and slowly move your foot and 
ankle against the resistance band 
Step 4: Slowly return to the starting position and repeat 10 times 
Tip: Keep your leg straight and heel on the floor for support. To increase resistance, 
move your hands down the resistance band toward your foot 
 
 
Dorsiflexion 
Step 1: Sit on the floor or a bed with your back supported and your legs straight out 
in front of you 
Step 2: Anchor the elastic band on a chair, table leg, or have another individual hold 
it for you. 
Step 3: Pull your toes toward you and slowly return to the starting position. 
Step 4: Repeat 10 times 
Tip: Keep your leg straight and heel on the floor for support. 
 
 
 

 
 
36
Biodex Clinical Protocol for testing Knee Flexion/Extension and 
Ankle Plantarflexion/Dorsiflexion: Testing Gastrocnemius and 
Soleus Strength 
Knee Flexion/Extension24 
- Bilateral Isokinetic 3 speed Evaluation 
o Biodex Multi-joint System 
o Concentric/Concentric 
o To establish goals and monitor progress 
o Instruct patient to perform through full ROM 
- Isokinetic Evaluation 3 Speed: 
o Full Active ROM 
o 100% Range 
o Reps & Speeds: 
▪ 5@ 60 deg/sec 
▪ 10 @180 deg/sec 
▪ 15 @300 deg/sec 
 
Ankle Plantarflexion/Dorsiflexion25 
- 
Bilateral Isokinetic 2 speed evaluation 
o Biodex Multi-joint System 
o Concentric/Concentric 
- 
Isokinetic Evaluation 2 Speed: 
o Patient supine, support under distal femur, knee flexed to 10deg 
o Reps & Speeds: 
▪ 5 @ 60 deg/sec 
▪ 10 @ 120 deg/sec 
 

 
 
37
 
 
 

 
 
38
 

 
 
39
 
 
 
 
 
 

 
 
40
 
 

 
 
41
 

 
 
42
 
 
 
 
 
 
 
 
 
 
 
 
VENOUS CLINICAL SEVERITY SCORE 
 
 
ATTRIBUTE 
ABSENT=0 
MILD=1 
MODERATE=2 
SEVERE=3 
PAIN 
NONE 
OCCASIONAL, NOT 
RESTRICTING ACTIVITY OR 
REQUIRING PAIN 
MEDICATION 
DAILY MODERATE ACTIVITY 
LIMITATION; OCCASIONAL 
PAIN MEDICATION 
DAILY, SEVERE LIMITING 
ACTIVITIES OR REQUIRING 
REGULAR USE OF PAIN 
MEDICATIONS 
VARICOSE VEINS 
NONE 
FEW SCATTERED 
MULTIPLE; GREAT SAPHENOUS 
VEINS, CONFINED TO CALF 
AND THIGH 
EXTENSIVE; THIGH AND CALF OR 
GREAT AND SMALL SAPHENOUS 
DISTRIBUTION 
VENOUS EDEMA 
NONE 
EVENING ANKLE SWELLING 
ONLY 
AFTERNOON SWELLING,  
ABOVE ANKLE  
MORNING SWELLING ABOVE 
ANKLE AND REQUIRING 
ACTIVITY CHANGE, ELEVATION 
SKIN PIGMENTATION 
NONE 
DIFFUSE, BUT LIMITED IN 
AREA AND OLD (BROWN) 
DIFFUSE OVER MOST OF 
GAITER DISTRIBUTION (LOWER 
THIRD) OR RECENT 
PIGMENTATION (PURPLE) 
WIDER DISTRIBUTION (ABOVE 
LOWER THIRD) PLUS RECENT 
PIGMENTATION 
INFLAMMATION 
NONE 
MILD CELLULITIS, LIMITED 
TO MARGINAL AREA 
AROUND ULCER 
MODERATE CELLULITIS, 
INVOLVES MOST OF (LOWER 
THIRD) 
SEVERE CELLULITIS (LOWER 
THIRD AND ABOVE)  
OR SIGNIFICANT 
INDURATION 
NONE 
FOCAL, CIRCUMMALLEOLAR 
MEDIAL OR LATERAL, LESS 
THAN LOWER THIRD OF LEG 
ENTIRE LOWER THIRD OF LEG OR 
MORE 
NUMBER OF ACTIVE 
ULCERS 
0 
1 
2 
>2 
ACTIVE ULCER 
DURATION 
NONE 
<3 MONTHS 
>3 MONTHS, <1YEAR 
NOT HEALED>1 YEAR 
 
 
 
 
ACTIVE ULCER 
DIAMETER 
NONE 
<2 
2-6 
>6 
 
 
 
 
COMPRESSION 
THERAPY 
NOT USED OR 
PATIENT NOT 
COMPLIANT 
INTERMITTANT USE OF 
STOCKINGS 
WEARS ELASTIC STOCKING 
MOST DAYS 
FULL COMPLIANCE, 
STOCKINGS+ELEVATION 
 

 
 
43
 
          PARTICIPANT INFORMED CONSENT 
Effect of Structured Exercise in Individuals with Chronic Venous Insufficiency 
 
Date: 26.10.2017 
Introduction:  
 
You are invited to participate in our research study. This research study aims to 
examine if a special exercise programme, called “Strength from within” can improve calf 
muscle strength and function, overall physical strength, movements of the ankle joint and 
have a positive impact on quality of life. This study is being done as we know that 
improvement in calf muscle strength can improve the flow of blood in veins in patients with 
varicose veins. Therefore, we want to see if our exercise programme carried out at home can 
also benefit patients with varicose veins. During this study, you will complete a questionnaire 
regarding your quality of life (at the beginning and end of the study) and answer questions on 
symptoms you may have due to your varicose veins. Measurements will be taken of your calf 
muscle strength and function, overall physical strength and movements of the ankle joint by 
the study researcher. These measures will be taken again at the end of the study (week 12). 
If you have any further questions do not hesitate to ask. 
 
Procedure: 
You will be shown how to do the exercises by the study researcher and asked to carry this out 
6 days a week at home at a time that suits you. Clear instructions and demonstration of the 
exercises will be given to you at the start of the study. Also, a programme of which exercises 
and how much you exercise will be provided to you according to your capabilities. You will 
also be given the exercise brochure called “Strength from within” which shows all exercises 
and how to do these. Finally, you will be asked to keep a record of your exercises during the 
study.   
The study researcher will contact you each week at a time that suits you to check on your 
week’s exercise plan and make adjustment for the next week. The study researcher will keep 
a record of your exercise plan for each week.  
 
 
 
Benefits and Risks for participants: 
 
The findings of this study will be presented to the team of the healthcare professionals 
involved at the Galway Clinic and University Hospital Galway. This research may help improve 
your calf muscle strength and function, reduce symptoms of varicose veins, overall physical 
strength and have a positive impact on your quality of life. Other benefits your may have from 
doing exercises in this study are lowering your risk of cardiovascular disease, stress reduction, 
possible weight loss, reduced cholesterol levels, reduce your risk of developing type 2 
diabetes and lowering of your blood pressure. The structured exercise programme does not 
exceed international recommendations and guidelines for adults by the American College of 
Sport’s Medicine. 
 
With any exercise, there is the possibility that abnormal responses could occur. While 
these risks are low for this type of exercise, they can include: unexpected changes in blood 
pressure, irregular heart rate, shortness of breath, fatigue, muscle cramps, muscle soreness, 
or joint injury, and in rare cases, a cardiac event. Investigators will have evaluated you using 

 
 
44
a pre-study health screening to ensure that you do not have a health condition where exercise 
is contraindicated. Risks will be minimized through an exercise plan which contains a standard 
exercise protocol, with a warm-up and cool-down at the start and end of each exercise session 
carried out by you. Participants are instructed to stop the program if they are having any 
abnormal responses and contact the principal investigator. 
 
Compensation: 
No tangible compensation will be given. 
 
Confidentiality: 
 
Any information obtained during this study, which could identify you will be kept 
confidential. Information may be published in professional/scientific journals or at 
professional meetings, however your identity will be kept strictly confidential by a coded 
procedure. 
 
Right to Refuse or Withdrawal: 
 
I understand that it is my responsibility to notify the researcher if I experience any 
abnormal responses during or following the program. I will do what I think is safe for myself 
and will not exceed these limits. I understand that I have the right to refuse to participate or 
withdraw from participation of this study at any time without penalty. I know I may change 
my mind about being in the study or withdraw from the study after it begins. If the study 
design or use of the data changes I will be informed and consent be revised. 
 
 
 
 
Name Printed 
 
 
 
 
Signature & Date 
 
 
 
 
Researcher’s Signature & Date 
 
 
 
 
 
 
 

 
 
45
       
 
 
PARTICIPANT INFORMATION LEAFLET 
Effect of Structured Exercise in Individuals with Chronic Venous Insufficiency 
Date: 26.10.2017 
 
Introduction:  
 
You are invited to participate in our research study. This research study aims to 
examine if a special exercise programme, called “Strength from within” can improve calf 
muscle strength and function, overall physical strength, movements of the ankle joint and 
have a positive impact on quality of life. This study is being done as we know that 
improvement in calf muscle strength can improve the flow of blood in veins in patients with 
varicose veins. Therefore, we want to see if our exercise programme carried out at home can 
also benefit patients with varicose veins. During this study, you will complete a questionnaire 
regarding your quality of life (at the beginning and end of the study) and answer questions on 
symptoms you may have due to your varicose veins. Measurements will be taken of your calf 
muscle strength and function; overall physical strength and movements of the ankle joint by 
the study researcher. These measures will be taken again at the end of the study (week 12). 
If you have any further questions do not hesitate to ask. 
 
Procedure: 
You will be shown how to do the exercises by the study researcher and asked to carry this out 
6 days a week at home at a time that suits you. Clear instructions and demonstration of the 
exercises will be given to you at the start of the study. Also, a programme of which exercises 
and how much you exercise will be provided to you according to your capabilities. You will 
also be given the exercise brochure called “Strength from within” which shows all exercises 
and how to do these. Finally, you will be asked to keep a record of your exercises during the 
study. 
The study researcher will contact you each week at a time that suits you to check on your 
week’s exercise plan and make adjustment for the next week. The study researcher will keep 
a record of your exercise plan for each week. 
 
 
Session Two will occur after the completion of your 12-weeks. At this session, you will 
complete a questionnaire on your quality of life and will be asked a few questions on your 
symptom. The study researcher will collect your recording booklet, but you are welcome to 
keep your strength from within booklet and resistance band. Three months after you have 
completed the study the study researcher will contact you by phone to complete a 
questionnaire. 
 
Benefits and Risks for participants: 
 
The findings of this study will be presented to the team of the healthcare professionals 
involved at the Galway Clinic and University Hospital Galway. This research may help improve 
your calf muscle strength and function, reduce symptoms of varicose veins, overall physical 
strength and have a positive impact on your quality of life. Other benefits your may have from 
doing exercises in this study are lowering your risk of cardiovascular disease, stress reduction, 
possible weight loss, reduced cholesterol levels, reduce your risk of developing type 2 
diabetes and lowering of your blood pressure. The structured exercise programme does not 

 
 
46
exceed international recommendations and guidelines for adults by the American College of 
Sport’s Medicine. 
With any exercise, there is the possibility that abnormal responses could occur. While 
these risks are low for this type of exercise, they can include: unexpected changes in blood 
pressure, irregular heart rate, shortness of breath, fatigue, muscle cramps, muscle soreness, 
or joint injury, and in rare cases, a cardiac event. Investigators will have evaluated you using 
a pre-study health screening to ensure that you do not have a health condition where exercise 
is contraindicated. Risks will be minimized through an exercise plan which contains a standard 
exercise protocol, with a warm-up and cool-down at the start and end of each exercise session 
carried out by you. Participants are instructed to stop the program if they are having any 
abnormal responses and contact the principal investigator. 
 
Confidentiality: 
 
Any information obtained during this study, which could identify you will be kept 
confidential. Information may be published in professional/scientific journals or at 
professional meetings, however your identity will be kept strictly confidential by a coded 
procedure. 
 
Right to Refuse or Withdrawal: 
 
I understand that it is my responsibility to notify the researcher if I experience any 
abnormal responses during or following the program. I will do what I think is safe for myself 
and will not exceed these limits. I understand that I have the right to refuse to participate or 
withdraw from participation of this study at any time without penalty. I know I may change 
my mind about being in the study or withdraw from the study after it begins. If the study 
design or use of the data changes I will be informed and consent be revised. 
 
 
Please contact researcher for any further questions. 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
47
 
 
 
Physical Activity Levels in Individuals with Chronic Venous Insufficiency   
 
Questionnaire: please answer all questions. If you have any questions 
please ask the researcher. All information gathered will be recorded 
anonymously. 
 
  
1) Age ____________years 
  
2) What is your gender? 
Female 
 Male 
3) Do you wear compression stockings? 
Yes 
 No (skip question 4 if no) 
4) If yes, how many hours a day do you wear compression stockings? 
 
5) What type of setting do you live in? 
Rural Setting    
Suburb Setting 
 
6) Overall, how would you categorize your current health status? 
Excellent 
 
Very Good 
 
Good 
 
Fair 
 
Poor 
 
 
7) What is your main form of transport? 
                      Car         
Bus         
Train 
Taxi/Car Service 
Other 
 
 
Study Researcher Purpose Only 
Trial ID: 
 
 
0-6 
6-12 
12-18 
18-24 

 
 
48
 
 
8) During your day, which of the following best describes what you do? 
   Mostly sitting or standing 
 
      
Mostly Walking  
 
   
Mostly heavy labour or physically demanding 
 
 
 
9) How often do you exercise? (not including labour done at work) 
Never 
 
A few times per month 
 
A few times per week 
 
Almost every day 
 
 
10)  If you do exercise, how long do you spend exercising each day? 
10-20 minutes 
 
20-30 minutes 
 
30-60 minutes 
 
60+ minutes 
 
11) What type of exercise do you do? (Tick all that apply) 
 
Walking 
 
Jogging 
 
Swimming 
 
Biking 
 
Weightlifting 
 
Yoga/Pilates 
 
Gym Class (spin, HIIT, etc.) 
 
Other ____________________ 

 
 
49
         
 
 
 
 
12) Do you feel your physical activity levels are sufficient to benefit your health status?  
           Yes                                    No                                         Don’t know 
  
13) Do you feel that physical activity can positively affect your health? 
  Yes                                             No                                    Don’t know 
 
 
14) If you are currently diagnosed with any of the conditions listed below please tick 
the box (tick all that apply to you) 
  
Obesity 
 
Hypertension (high blood pressure) 
 
Venous Thrombosis 
 
Coronary Heart Disease 
 
Diabetes 
 
Arthritis 
 
Dyspena (difficulty breathing) 
 
Angina 
 
Asthma 
 
 
 
 
 
 
 
 
 

 
 
50
 
 
 
Three-Month Follow Up to Exercise in Individuals with Chronic Venous 
Insufficiency 
 
Questionnaire: please answer all questions. If you have any questions 
please ask the researcher. All information gathered will be recorded 
anonymously. 
 
  
1) Age ____________years 
  
2) What is your gender? 
    Female       
Male     
    
3) Do you walk during the week? 
Yes 
 
No 
 
4) If yes, how many minutes a week do you walk roughly 
 
10-20 minutes 
 
20-30 minutes 
 
30-60 minutes 
 
60+ minutes 
 
5) During your day, which of the following best describes what you do? 
   Mostly sitting or standing 
 
Mostly Walking  
 
   
Mostly heavy labour or physically demanding 
 
6) How often do you exercise? (not including labour done at work) 
Never 
 
A few times per month 
Study Researcher Purpose Only 
Trial ID: 
 
 

 
 
51
 
A few times per week 
 
Almost every day 
 
 
7)  If you do exercise, how long do you spend exercising each week? 
10-20 minutes 
 
20-30 minutes 
 
30-60 minutes 
 
60+ minutes 
 
8) What type of exercise do you do? (Tick all that apply) 
 
Walking 
 
Jogging 
 
Swimming 
 
Biking 
 
Weightlifting 
 
Yoga/Pilates 
 
Gym Class (spin, HIIT, etc.) 
 
 Strength From Within Programme 
 
Other ____________________ 
         
 
 
9) Do you feel your current physical activity levels are sufficient to benefit your 
health status?  
    Yes                                         No                                     Don’t know 
 
 
 
 
10) Do you feel that physical activity has positively affected your health? 
 Yes                                           No                                        Don’t know 

 
 
52
 
 
Baseline Recording Chart 
Trial ID: 
 
 
Date: 
Week Of Baseline: 
6 Minute Walk Test: 
 
 
 
 
Single Leg Balance (30 seconds): 
 
 
 
Step Overs (30 seconds): 
 
 
 
 
Laps: 
Total: 
Right Leg: 
 
 
Left Leg: 
Total Number of Step Overs: 

 
 
53
Sit To Stand (30 seconds): 
 
 
Push Press (30 seconds): 
 
 
 
 
 
 
Bicep Curl (30 Seconds): 
 
 
Triceps Extension (30 seconds): 
 
 
 
 
 
Total: 
Total: 
     Right Arm: 
       Left Arm: 
     Right Arm: 
     Left Arm: 

 
 
54
Biodex Information Sheet 
 
1. Turn on system 
2. Calibrate Biodex, reconnect with biodex (click blinking start) 
3. Knob will turn and calibrate on dynamometer 
4. Check list is on the left side on the pop up on the computer 
5. Patient information (first and last name, gender, involved leg if injured) 
a. For our trial hit NONE 
6. Need to add weight 
7. ID Number and click save 
8. Second tab on the left side still is your protocol tab 
a. Protocol is dependent on situation and test 
9. Options will come up and select Isokinetic Bilateral 
10. Select knee and ankle 
11. Hit done 
12. Bottom black knob allows the whole unit to turn around to test opposite leg 
13. Set up to 90 when changing from right to left and left to right and lock the device in 
14. To move the whole machine to test opposite leg, step on the small steps behind the 
platform and slide the device across the chair 
15. SEAT SET UP 
16. Have patient sit in the chair 
17. Step on lever at the side of the chair and pull chair forward to have the ability to go 
around the entire chair 
18. Have the patient bring their hips all the way to the back of the chair and be sitting 
flat 
19. Looking for two finger width of space from the back of the knee to the chair 
a. Needs to be able to have full EXT/FLEX 
20. To move the patient forward or backward on the chair use the circular handle on the 
back of the chair that will produce that action 
21. Have the patient readjust and hips are all the way back 
22. Shoulder, hip, leg and ankle strap 
23. Bring the strap down to the clasp 
a. Shoulder straps go to the back claps, have the strap snug but not tight 
b. Ask the patient: does that feel comfortable? It is going to be snug but should 
not be hurting 
c. Waist strap over the hips into the clasp on the chair, tight but not debilitating 
i. Reason for the straps: making sure the leg is the only thing generating 
momentum 
24. SET UP DYNAMOMETER 
a. On each handle has the corresponding marking for each leg 
b. Ankle should be going right on the ankle pad 
c. Place the handle into the dynamometer 
d. Use the black screw knob to lock in the handle to the dynamometer 
e. Have the patient rest their leg on the ankle pad and move the chair forward 
to line the knee with the black knob for an axis of rotation 
f. The leg should be close but not rubbing against the black knob 
g. Thigh strap goes over the leg that is being tested, tight but snug. 

 
 
55
i. Tight as they are comfortable with 
h. Ankle strap goes across the leg with the ankle pad sitting right on the back of 
the ankle 
i. The pad can be moved if adjusting is needed with the black knob half 
way down the bar 
25. BACK TO THE COMPUTER 
a. SET ROM (looks like a T) 
b. Yes, to ROM limits 
c. Press the computer control button 
d. Automatically take to the next screen 
e. Make sure you have the correct leg selected 
f. Ability to move the leg in and our 
g. Set the away and toward limits 
h. Hold clicker 
i. Instruct the patient to kick their leg out as far as they can 
j. Hold the leg and click the clicker to lock patient in 
k. Computer will say AWAY limit and click SET 
l. After hit set, use the click to set free 
m. As the leg is set free instruct the patient to pull their leg as far in as they can 
n. Lock patient in 
o. Set toward limit  
p. On the screen, it has a red A&T 
i. Means leg was properly set 
ii. Hit continue to free the leg 
26. SET NATURAL 90 
a. Instruct the patient to take a deep breath and let their leg hang naturally 
b. Click the T to set his natural range or natural 90 
27. WEIGH THE LEG 
a. Instruct the patient to kick their leg out as far as they can and hold it 
b. Lock the patient in by the clicker 
i. And relax 
c. Instruct the patient to take a deep breath in and relax completely to weigh 
the leg 
d. Hit the scale that says limb weight 
i. Important: because if they are putting any type of pressure on the 
pad they will increase the leg any contraction will weigh less 
ii. The machine will add and correct for it when measure for power, 
work, torque etc. 
28. READY TO START THE TEST 
a. Before starting the test be sure to explain the test to the subject 
i. Knee FLEX/EXT 
1. You will be going through three evaluating speeds on each leg 
2. The first one will be 60 per second and you will complete 5 
repetitions. 
3. 30-60 second break 
4. Second speed will be at 180 per second with 10 repetitions 
5. 30-60 second break 

 
 
56
6. The third and final speed will be a 300 per second with 15 
repetitions 
7. Break 
ii. Ankle plantar flexion/dorsiflexion 
1. You will be going through 2 evaluating speeds on each leg 
2. The first test will be at 60 per second with 5 repetitions 
3. 30-60 second break 
4. The second speed will be at 120 per second with 10 
repetitions 
b. The GO button will not start the test the test starts when the subject stops 
moving the leg 
i. Give the patient a test runs 
1. One at 50%, 75% and 100% (respectively) 
ii. After the three tests runs are done have the patient pull the leg back 
completely and hold the leg back to start the leg 
c. The computer will tell you when to go 
d. Encourage the patient and follow the progress on the screen 
e. DO NOT TELL THE PATIENT WHERE THEY ARE IN REPETITIONS 
i. Can affect the end result 
f. Computer will hit 100% done 
g. Immediately when FINISHED unstrapping the patient so they are free and 
bale to relax 
h. Instruct the patient to come out of the chair carefully and assist them to a 
resting point 
i. Computer will say all sets have been complete and hit YES to finish the test 
j. The last step 
i. Hit report 
ii. Comprehensive evaluation 
iii. Use metric units 
iv. Print, OK 
v. Reports will be generated 
29. Tip on results 
a. All reps will be given 
b. Graph will show a fatigue 
i. Should start high and end low 
ii. If it starts low and goes high something went wrong