Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to analyze the effect of 12 weeks of arm crank exercise (ACE) training on cardiovascular function in PAD patients, and compare it with treadmill exercise (TE), the actual recommendation for this patients. In this clinical trial, 45 patients will be allocated randomly in three experimental groups: ACE training, TE and control group. ACE and TE groups will perform exercises twice a week with the intensity equivalent to 13- 15 on Borg's Subjective Perception Exertion Scale. Patients in control group will meet twice a week, however only to perform diverse activities and group living, without any type of exercise involved. All groups will be encouraged to increase their levels of activity, as they are usually guided in medical consultations. Before and after 12 weeks of intervention, cardiovascular function, functional capacity, cognition, and quality of life will be assessed.

Detailed Description
-----------------
Arm-crank exercise (ACT) is an alternative exercise strategy for patients with symptomatic peripheral artery disease (PAD) due the benefits on functional capacity and quality of life, besides provoking less or no pain symptoms during the execution. This study sought to describe the protocol of a study that will analyse the effect of ACT exercise on walking capacity, cardiovascular function, cognition and quality of life in patients with symptomatic PAD. This is a three-armed randomized, prospective, single-blind data collection, single-center, controlled study enrolling 45 patients with symptomatic PAD which will be randomized into 3 intervention groups: walking training (WT), ACT (WT and AC: 15 to 10 sets of 2 to 5 minutes, Borg 13 to 15) and control group (CG). Before and after 12 weeks of intervention, cardiovascular function (ambulatory blood pressure , clinic blood pressure, central blood pressure, heart rate variability, arterial stiffness, vascular function), functional capacity (six-minute walking test, 2 minute step test [2 MST], Walking impairment questionnaire [WIQ], Walking estimated limitation calculated by history [WELCH], Baltimore activity scale for intermittent claudication, handgrip test and short physical performance battery [SPPB]), cognition (executive function and memory) and quality of life (short version of world health organization quality of life and vascular quality of life questionnaire [VASCUQOL-6]) will be assessed. This is the first trial to evaluate the effects of ACT on regulatory mechanisms of cardiovascular system in PAD patients. If the results are as expected, they will provide evidence of ACT in promoting cardiovascular benefits in symptomatic PAD population.

Official Title
-----------------
Effects of Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease: a Randomized Controlled Trial

Conditions
-----------------
Peripheral Arterial Disease, Intermittent Claudication, Hypertension

Intervention / Treatment
-----------------
* Other: Arm ergometer
* Other: Treadmill ergometer
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PAD stage II Ankle brachial index <0.90 in one or both lower limbs; Women in post-menopause phase without hormone replacement therapy Not an active smoker; Able to perform exercise training; Patients selected to participate in the study will be only excluded if: Change their medication; Present any health impairment that contraindicates the practice of physical exercise during the study;

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm crank ergometer<br>Arm-crank exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard. | Other: Arm ergometer<br>* Arm-crank exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard<br>|
| Experimental: Treadmill ergometer<br>Walking exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard. | Other: Treadmill ergometer<br>* Walking exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard.<br>|
| Other: Control group<br>Patients randomized to control group will attend to meetings with the researcher team twice a week during the 12 weeks. At these meetings, patients will perform manual tasks, with or without the use of artistic materials, cultural programs, cooking classes and home care, without any exercise component. This CG practice will be performed in order to minimize the effects of the patient's bi- weekly commitment and displacement to the training site, to minimize the influence of the patient- researcher contact and also minimize the convivial effect among the patients themselves, which will occur in the other two groups. | Other: Control group<br>* Patients randomized to control group will attend to meetings with the researcher team twice a week during the 12 weeks. At these meetings, patients will perform manual tasks, with or without the use of artistic materials, cultural programs, cooking classes and home care, without any exercise component. This CG practice will be performed in order to minimize the effects of the patient's bi- weekly commitment and displacement to the training site, to minimize the influence of the patient- researcher contact and also minimize the convivial effect among the patients themselves, which will occur in the other two groups.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ambulatory blood pressure | Systolic, diastolic and mean blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic ambulatory blood pressure monitor (Cardios, São Paulo, Brazil). | Change from baseline in ambulatory blood pressure at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinic blood pressure | Systolic and diastolic brachial blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan). | Change from baseline in ambulatory blood pressure at 12 weeks | 
| Central blood pressure | Systolic and diastolic central blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan). | Change from baseline in ambulatory blood pressure at 12 weeks | 
| Heart rate variability | Heart rate variability will be measured before and after 12 weeks of intervention period on intervention and control group by heart rate monitor (Polar, RS 800, USA). | Change from baseline in ambulatory blood pressure at 12 weeks | 
| Arterial stiffness | Carotid femoral pulse wave velocity will be measured before and after 12 weeks of intervention period on intervention and control group by pulse wave velocity measurement with applanation tonometry (SphygmoCor, AtCor Medical, Australia). | Change from baseline in arterial stiffness at 12 weeks | 
| Vascular function | Flow-meadiated dilation will be measured before and after 12 weeks of intervention period on intervention and control group by a flow mediated dilation measurement with an ultrasound image (HDI 5000 Sono CT, Philips, The Netherlands). | Change from baseline in flow-mediated vasodilation at 12 weeks | 
| Walking capacity | Six-minute walking test will be measured before and after 12 weeks of intervention | Change from baseline in walking distance at 12 weeks | 
| March in place | Two-minute step test will be measured before and after 12 weeks of intervention | Change from baseline in the number of the steps at 12 weeks | 
| Subjective measurement of walking capacity | Walking impairment questionnaire will be measured before and after 12 weeks of intervention | Change from baseline in the walking impairment questionnaire score after 12 weeks | 
| Subjective measurement of walking capacity compared to healthy subjects | Walking estimated limitation calculated by history questionnaire will be measured before and after 12 weeks of intervention | Change from baseline in the Walking estimated limitation calculated by history questionnaire score after 12 weeks | 
| Overall strength test | Handgrip strength test will be measured before and after 12 weeks of intervention | Change from baseline in kgf of the handgrip test after 12 weeks | 
| Symptoms of intermittent claudication | The Baltimore Activity Scale for Intermittent Claudication is a questionnaire that will be measured before and after 12 weeks of intervention. | Change from baseline in the Baltimore Activity Scale for Intermittent Claudication score after 12 weeks | 
| General functional capacity | The Short Physical Performance Battery will be measured before and after 12 weeks of intervention. | Change from baseline in the Short Physical Performance Battery score after 12 weeks | 
| Specific quality of life of vascular patients | The Vascular quality of life questionnaire will be measured before and after 12 weeks of intervention. | Change from baseline in the Vascular quality of life questionnaire score after 12 weeks | 
| General quality of life | The World Health Organization Quality of Life questionnaire will be measured before and after 12 weeks of intervention | Change from baseline in the World Health Organization Quality of Life score after 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arm-crank, exercise training, cardiovascular function