The Efficacy of a Self-managed Resistance Training Protocol Versus a Predetermined Resistance Training Protocol in Reducing Pain in Individuals With Plantar Fasciopathy During a 12-week Intervention: a Randomised Controlled Superiority Trial
Phase: NA
Conditions: Plantar Fasciopathy
Sponsor: Aalborg University

Title 
The efficacy of a self-managed resistance training protocol versus a predetermined 
resistance training protocol in individuals with plantar fasciopathy during a 12-week 
intervention: a randomised controlled superiority trial  
NCT-Number 
NCT03304353 
Date 
November 7th 2017 
 

1 
Descriptive title identifying the study design, population, 
interventions, and, if applicable, trial acronym 
The efficacy of a self-managed resistance training protocol versus a predetermined 
resistance training protocol in individuals with plantar fasciopathy during a 12-week 
intervention: a randomised controlled superiority trial  
2a 
Trial identifier and registry name. If not yet registered, name of 
intended registry 
2b 
All items from the World Health Organization Trial 
Registration Data Set 
Data category 
Information 
Primary registry and trial identifying number 
Clinicaltrials.gov (NCT03304353) 
Date of registration in primary registry 
October 9th 2017 
Secondary identifying numbers 
N-20170051 
Source(s) of monetary or material support 
Research Unit for General Practice in Aalborg and 
Aalborg University 
Primary sponsor 
Research Unit for General Practice in Aalborg  
Secondary sponsor(s) 
Aalborg University 
Contact for public queries 
hriel@dcm.aau.dk 
Contact for scientific queries 
hriel@dcm.aau.dk 
Public title 
The efficacy of a self-managed resistance training 
protocol versus a predetermined resistance training 
protocol in individuals with plantar fasciopathy during 
a 12-week intervention: a randomised controlled 
superiority trial 
Scientific title 
The efficacy of a self-managed resistance training 
protocol versus a predetermined resistance training 
protocol in individuals with plantar fasciopathy during 
a 12-week intervention: a randomised controlled 
superiority trial 
Countries of recruitment 
Denmark 
Health condition(s) or problem(s) studied 
Plantar fasciopathy 
Intervention(s) 
Intervention: self-managed training programme 
Control: predetermined training programme 
Key inclusion and exclusion criteria 
Inclusion criteria: History of inferior heel pain for at 
least 3 months before enrolment; pain on palpation 
of the medial calcaneal tubercle or the proximal 
plantar fascia; thickness of the plantar fascia of 4.0 
mm or greater; and mean heel pain of ≥ 20 mm on a 
100 mm VAS during the previous week 
Exclusion criteria: Below 18 years of age; diabetes; 
history of inflammatory systemic diseases; prior heel 
surgery; pregnancy or; corticosteroid injection for 
plantar fasciopathy within the previous six months 
Study type 
Interventional, randomised, participant blinded, 
parallel assignment, superiority 
Date of first enrollment 
October 12th 2017 

Target sample size 
70 
Recruitment status 
Recruiting 
Primary outcome(s) 
Foot Health Status Questionnaire pain domain score 
Key secondary outcomes 
Total Foot Health Status Questionnaire score; 
Plantar fascia thickness; Compliance to exercise; 
Global Rating of Change; Patient Acceptable 
Symptom State; Pain Self-Efficacy Questionnaire; 
International Physical Activity Questionnaire  
 
3 
Date and version identifier 
November 7th 2017, version 3.1 
4 
Sources and types of financial, material, and other support 
5a 
Names, affiliations, and roles of protocol contributors 
The project will be conducted with HR as primary investigator. All authors are expected to 
make substantial scientific contributions to the design of the study that will qualify them as 
authors. HR and MSR wrote the first draft of the protocol. MBJ, BV and JLO are all 
expected to make valuable scientific additions to the draft and will be co-authors on 
subsequent manuscripts based on these data. The definition of author is defined on 
ICMJE´s four criteria (1):  
 
 
Substantial contributions to the conception or design of the work; or the acquisition, 
analysis, or interpretation of data for the work; AND 
 
Drafting the work or revising it critically for important intellectual content; AND 
 
Final approval of the version to be published; AND 
 
Agreement to be accountable for all aspects of the work in ensuring that questions 
related to the accuracy or integrity of any part of the work are appropriately 
investigated and resolved. 
   
The expected author list is: Riel H; Jensen MB; Vicenzino B; Olesen JL; Rathleff MS  
 
5b 
Name and contact information for the trial sponsor 
Trial sponsor: Research Unit for General Practice in Aalborg. 
Contact name: Michael Skovdal Rathleff 
Address: Research Unit for General Practice in Aalborg, Fyrkildevej 7, 1., 9220 Aalborg 
East, Denmark  
E-mail: misr@hst.aau.dk 
 
5c 
Role of study sponsor and funders, if any, in study design; 
collection, management, analysis, and interpretation of data; writing of 

the report; and the decision to submit the report for publication, 
including whether they will have ultimate authority over any of these 
activities 
Sponsor is part of the study design, data analyses and writing of the manuscript. Sponsor 
will ensure that the results will be submitted for publication. Sponsor is non-commercial 
and declares no conflict of interest. 
 
5d 
Composition, roles, and responsibilities of the coordinating 
centre, steering committee, endpoint adjudication committee, data 
management team, and other individuals or groups overseeing the trial, 
if applicable (see Item 21a for data monitoring committee) 
N/A 
 
 
6a 
Description of research question and justification for 
undertaking the trial, including summary of relevant studies (published 
and unpublished) examining benefits and harms for each intervention 
Background and rationale 
Plantar fasciopathy (PF) is the most commonly reported cause of severe and sharp heel 
pain with a lifetime prevalence of 10% (2–5). Pain is often exacerbated during the first 
steps in the morning and after prolonged periods of rest (6). It is one of the most prevalent 
musculoskeletal conditions and PF is most often seen among runners (4) and 40 to 60-
year-old individuals with a low activity level and a high BMI (7). It accounts for an 
estimated one million patient visits per year to general practitioners in the US with similar 
high rates in Denmark. The majority of patients will experience pain for more than 12 
months and 6% of patients will lose an average of 19 workdays because of their heel pain 
(8–10). Thus, PF can be debilitating to the patient and have large societal costs. 
Standard care consists of gel heel inserts and stretching of the plantar fascia which are 
superior to placebo treatment. Despite such evidence, 40% will continue to have 
symptoms two years after the initial diagnosis (8). 
A recent study by Rathleff et al. 2015 investigated the efficacy of high-load strength 
training and gel heel inserts compared to plantar-specific stretching and gel heel inserts 
(9). Participants randomised to high-load strength training had a 29 points lower Foot 
Function Index after three months corresponding to a medium effect size. High-load 

resistance exercise is frequently used during rehabilitation of tendinopathies, but optimal 
mode and dosages in reducing pain are unknown (9,11–14).  
The exercise dose used in the study by Rathleff et al. was smaller than the exercise doses 
that have been used in the successful treatment of other tendinopathies (9,14–18). A 
larger dose could potentially lead to a faster recovery but this has yet to be investigated. 
Poor adherence to exercises is often a large barrier to overcome in rehabilitation and may 
affect the outcome and the dose received negatively (19,20). Low self-efficacy is seen as 
one of the reasons for poor adherence and may be increased by a self-managed loading 
programme and patient education (20). 
 
7 
Specific objectives or hypotheses 
Objectives 
The purpose of this trial is to investigate whether a self-managed resistance training 
programme is more effective than a predetermined resistance training programme in 
improving the Foot Health Status Questionnaire pain domain score in individuals with 
plantar fasciopathy after a 12-week intervention. 
 
Hypotheses 
Hypothesis: the self-managed resistance training programme will lead to a larger 
improvement in the Foot Health Status Questionnaire pain domain score compared with 
the predetermined programme in individuals with plantar fasciopathy after a 12-week 
intervention.  
 
8 
Description of trial design including type of trial (eg, parallel 
group, crossover, factorial, single group), allocation ratio, and 
framework (eg, superiority, equivalence, noninferiority, exploratory) 
Study design 
This study, which is called “The efficacy of a self-managed resistance training protocol 
versus a predetermined resistance training protocol in reducing pain individuals with 
plantar fasciopathy during a 12-week intervention: a randomised controlled superiority 
trial”, will be designed as a randomised, participant-blinded, superiority trial, with a 2-group 
parallel design to be conducted in Denmark. Reporting of this study will follow CONSORT 
guidelines for reporting non-pharmacologic treatments and TIDieR for intervention 

description (21–23). Reporting of the protocol will follow the SPIRIT statement (24). The 
planning of the study was done in accordance with the PREPARE Trial guide (25). Before 
the inclusion of the first participant, the study was registered on clinicaltrials.gov.  
 
Methods: Participants, interventions, and outcomes 
9 
Description of study settings (eg, community clinic, academic 
hospital) and list of countries where data will be collected. Reference to 
where list of study sites can be obtained 
The study will be conducted at the Research Unit for General Practice in Aalborg, 
Denmark. 
 
 10 
Inclusion and exclusion criteria for participants. If applicable, 
eligibility criteria for study centres and individuals who will perform the 
interventions (eg, surgeons, psychotherapists) 
Inclusion criteria: History of inferior heel pain for at least three months before enrolment; 
pain on palpation of the medial calcaneal tubercle or the proximal plantar fascia; thickness 
of the plantar fascia of 4.0 mm or greater and; mean heel pain of ≥ 20 mm on a 100 mm 
VAS during the previous week (26)  
Exclusion criteria: Below 18 years of age; diabetes; history of inflammatory systemic 
diseases (26); prior heel surgery; pregnancy or; corticosteroid injection for plantar 
fasciopathy within the previous six months 
The primary investigator who will be responsible for inclusion, exercise instructions and 
data collection will be a registered physiotherapist with 6 years of experience in treating 
patients with musculoskeletal disorders.  
 
11a 
Interventions for each group with sufficient detail to allow 
replication, including how and when they will be administered 
Intervention 
The exercise used in both groups will be heel raises. Participants will be asked to 
complete the exercise standing with the forefoot on a step. The toes are maximally dorsi 
flexed by placing a towel underneath them. The participant is instructed to perform a heel 
raise to maximal plantar flexion in the ankle joint and afterwards to lower the heel to 

maximal dorsi flexion. Supporting oneself for balance by placing the hands on a wall or a 
rail is allowed. The participants in the self-managed group are instructed in performing the 
exercise with a load as heavy as possible but no higher than 8RM and for as many sets as 
possible. The difference in how the exercise is prescribed between groups is displayed in 
Table 1. If the participants feel they can perform more repetitions than their load 
corresponds to (e.g. 10 repetitions when the load is supposed to be 8RM) an external load 
consisting of a backpack with books to add weight will be used. 
Both groups receive patient education on their condition. They will be informed about what 
is known about the condition in terms of risk factors and aetiology, the pathology, activity 
modification, and the rationale for why their specific exercise programme (self-managed or 
predetermined) could lead to recovery. The participants of the predetermined group will be 
informed that this specific exercise and exercise programme has been found to be 
superior to stretching but it is important to follow the protocol as closely as possible. The 
participants of the self-managed group will be informed that this specific exercise has been 
found to be superior to stretching but based on previous research of other tendinopathies 
we believe that doing the exercise as heavy as possible but not heavier than 8RM and with 
as many sets as possible will increase the odds of recovery. Both groups are told that 
compliance to their protocol is very important and that compliance to the exercises are 
associated with their recovery. They are also informed about other types of evidence-
based treatments however, they are asked to refrain from seeking other treatments during 
the course of the study. A silicone heel cup will be given to all participants. If the 
participant already uses an insole or any other type of foot orthosis they will be allowed to 
continue wearing this if they do not want to use the heel cup.  
Table 1 Mechano-biological descriptors (27) 
 
Self-managed resistance 
training programme 
Predetermined 
resistance training 
programme 
1. Load magnitude 
As heavy as possible but 
no higher than 8RM 
Week 1+2: 12RM  
Week 3+4: 10RM 
From Week 5: 8RM  
2. Number of 
repetitions 
≥8 depending on the 
load 
Week 1+2: 12  
Week 3+4: 10 
From Week 5: 8 
3. Number of sets 
As many as possible 
Week 1+2: 3  
Week 3+4: 4 
From Week 5: 5 

4. Rest in between sets 
2 min 
2 min 
5. Number of exercise 
interventions (per (day) 
or week) 
3.5/week 
3.5/week 
6. Duration of the 
experimental period 
((day) or weeks) 
12 weeks 
12 weeks 
7. Fractional and 
temporal distribution of 
the contraction modes 
per repetition and 
duration (s) of one 
repetition 
3s concentric 
2s isometric 
3s eccentric 
3s concentric 
2s isometric 
3s eccentric 
8. Rest in-between 
repetitions ((s) or (min)) 
No 
No 
9. TUT ((s) or (min)) 
8s/repetition 
≥64s/set 
≥64s/training session 
Week 1+2:  
8s/repetition 
96s/set 
288s/training session 
Week 3+4: 
8s/repetition 
80s/set 
320s/training session 
From Week 5: 
8s/repetition 
64s/set 
320s/training session 
10. Volitional muscular 
failure 
Yes 
Yes 
11. Range of motion 
Full range of motion 
Full range of motion 
12. Recovery time in-
between exercise 
sessions ((h) or (d)) 
48 h 
48 h 

13. Anatomical 
definition of the 
exercise (exercise form) 
The participant is 
standing with the 
forefoot on a step. The 
toes are maximally dorsi 
flexed by placing a towel 
underneath them. The 
participant is instructed 
to perform a heel raise 
to maximal plantar 
flexion in the ankle joint 
and afterwards to lower 
the heel to maximal 
dorsi flexion. Supporting 
oneself for balance by 
placing the hands on a 
wall or a rail is allowed. 
The participant is 
standing with the 
forefoot on a step. The 
toes are maximally dorsi 
flexed by placing a towel 
underneath them. The 
participant is instructed 
to perform a heel raise 
to maximal plantar 
flexion in the ankle joint 
and afterwards to lower 
the heel to maximal 
dorsi flexion. Supporting 
oneself for balance by 
placing the hands on a 
wall or a rail is allowed. 
 
 
11b 
Criteria for discontinuing or modifying allocated interventions 
for a given trial participant (eg, drug dose change in response to harms, 
participant request, or improving/worsening disease) 
The study may also be discontinued by participant request or withdrawal of informed 
consent. If any participant experiences an adverse event (e.g. an injury to the 
musculoskeletal system such as a muscle tear, a muscle strain, a sprained joint, injury 
from falling, delayed onset of muscle soreness equal to or greater than 20 mm on a 0 to 
100 mm VAS that lasts for more than 48 h after performing the exercises or exacerbation 
of PF) and is not able to perform the exercise, the participant is asked to record the event 
and contact the primary investigator as soon as it occurs by phone, SMS or e-mail but the 
participant will not be withdrawn from the study.  
 
11c 
Strategies to improve adherence to intervention protocols, 
and any procedures for monitoring adherence (eg, drug tablet return, 
laboratory tests) 
All participants are told that compliance to the exercise is important and this will improve 
the odds of recovery. Complying with the exercise programme includes performing the 
exercise with the prescribed form, contraction time, number of repetitions and sets and the 
frequency the exercise is performed. Compliance is monitored by a self-reported training 
diary in which the participants are asked to fill out the number of repetitions, sets and the 
date the exercise was performed. The participants are also asked to record their use of 

foot orthoses in the training diary as an estimated percentage of the time they have worn 
shoes. All participants will be contacted either by telephone or by e-mail two weeks after 
inclusion to ask them if they have experienced any difficulties with performing the 
exercises and to encourage them to continue performing the exercises. 
 
11d 
Relevant concomitant care and interventions that are 
permitted or prohibited during the trial 
All participants who do not wear an insole prior to the trial will receive a silicone heel cup 
but are asked to refrain from seeking other types of treatment during the course of the trial. 
Participants are told to register any use of analgesic or anti-inflammatory substances. 
They will be told that participating in physical activity is acceptable as long as they do not 
feel exacerbation of their symptoms that outlasts the physical activity. 
 
12 
Primary, secondary, and other outcomes, including the 
specific measurement variable (eg, systolic blood pressure), analysis 
metric (eg, change from baseline, final value, time to event), method of 
aggregation (eg, median, proportion), and time point for each outcome. 
Explanation of the clinical relevance of chosen efficacy and harm 
outcomes is strongly recommended 
Primary outcome:  
 The primary outcome will be the change in the pain domain of the Foot Health 
Status Questionnaire (FHSQ) from baseline to the 12-week follow-up. The FHSQ is 
a self-report questionnaire ranging from 0 (poor foot health) to 100 (optimum foot 
health) that assesses multiple dimensions of foot health and function and has a high 
reliability (ICC=0.74-0.92) (28). The minimal important change of the pain domain is 
14.1 points (29). A Danish translation of the original questionnaire will be used. The 
translation was made using a dual panel approach (30). The questionnaire will be 
filled out by the participant at baseline and at the 4- and 12-week follow-up.  
 
Secondary outcomes: 
 Change in the function, footwear and general foot health domains of the FHSQ. 
 Global Rating of Change (GROC) at the 12-week follow-up. This will be used to 
measure the participants’ self-reported recovery on a 7-point Likert scale ranging 
from “much improved” to “much worse”. Participants are categorised as improved if 
they rate themselves as “much improved” or “improved” (category 6-7) and 

categorised as not improved if they rate themselves from “slightly improved” to 
“much worse” (category 1-5). 
 Difference in thickness of the plantar fascia measured in millimetres. Measurements 
will be performed using ultrasonography during baseline and at the 4- and 12-week 
follow-up. The participant is lying prone with the toes placed maximally dorsi flexed 
on the examination table a longitudinal scan is performed. An average of three 
measurements will be used. This method has been found reliable in a previous 
study (ICC=0.67-0.77) (31). 
 The number of training sessions performed throughout the intervention measured 
by a training diary that each participant is handed out at baseline. The participants 
will be instructed in filling out the number of repetitions and sets performed and the 
day on which they performed the exercise. 
 The time measured in days to the Patient Acceptable Symptom State (PASS). This 
will be used as a measure of when the participant achieves a self-reported 
satisfactory result and is therefore not necessarily a measure of complete recovery. 
PASS has been used to evaluate clinically relevant states in other musculoskeletal 
disorders and post-operative pain. (32–34) After the participant has reported PASS 
he or she is still instructed to continue performing the exercise as prescribed. 
 Change in self-efficacy as measured by the Pain Self-Efficacy Questionnaire 
(PSEQ) from baseline to the 12-week follow-up. The PSEQ ranges from 0 (not at all 
confident) to 60 (completely confident) with lower scores indicating lower self-
efficacy (35). The questionnaire will be filled out by the participant at baseline and at 
the 4- and 12-week follow-up. A Danish translation of the original questionnaire will 
be used. This translation has been validated in a Danish chronic pain population 
and has a high reliability (ICC=0.89) (36). 
 Change in physical activity level as measured by the International Physical Activity 
Questionnaire short version (IPAQ). The questionnaire will be filled out by the 
participant at baseline and at the 4- and 12-week follow-up. A Danish translation of 
the original questionnaire will be used. The IPAQ is the most commonly used 
questionnaire for measuring physical activity among adults and consists of 9 items 
that provide information on the time spent performing vigorous and moderate 
activities, the time spent walking, and time spent sedentary during the past week. 
The IPAQ gives an estimate of the total weekly physical activity measured in MET-
minutes per week and total minutes spent sitting.(37,38) 
 
 
13 
Time schedule of enrolment, interventions (including any run-
ins and washouts), assessments, and visits for participants. A 
schematic diagram is highly recommended (see Figure) 

Table 2: SPIRIT figure for the schedule of enrolment, interventions and assessments. 
 
 
Study period 
 
Enrolment 
Allocation 
Post-allocation 
Close-out 
TIMEPOINT** 
October 
1st 2017 – 
February 
1st 2018 
October 
1st 2017 – 
February 
1st 2018 
4-week 
follow-up 
 
January 1st 2017 
– May 1st 2018 
 
(12-week 
 follow-up) 
12-week 
Intervention 
ENROLMENT: 
 
 
 
 
 
Eligibility screen 
X 
X 
 
 
 
Informed consent 
 
X 
 
 
 
Allocation 
 
X 
 
 
 
INTERVENTIONS: 
 
 
 
 
 
Self-managed 
group 
 
 
 
 
 
Predetermined 
group 
 
 
 
 
 
ASSESSMENTS: 
 
 
 
 
 
Diagnosis 
 
X 
 
 
 
Foot Health 
Status 
Questionnaire 
 
X 
X 
 
X 
Plantar fascia 
thickness 
 
X 
X 
 
X 
Pain Self-Efficacy 
Questionnaire  
 
X 
X 
 
X 

 
14 
Estimated number of participants needed to achieve study 
objectives and how it was determined, including clinical and statistical 
assumptions supporting any sample size calculations 
It is expected that the self-managed group will experience a larger reduction of the FHSQ 
pain domain of 14.1 points compared with the predetermined group. This is equal to the 
minimal clinical important difference of the domain (29). Based on a standard deviation of 
20 points, which is comparable to the overall standard deviations found in previous studies 
of this patient population (26,39–41), a two-sided 5 % significance level and a power of 80 
%, a sample size of 33 participants in each group will be necessary. Taking into 
consideration possible drop-outs, we will include a total of 70 participants. 
 
15 
Strategies for achieving adequate participant enrolment to 
reach target sample size 
Seventy participants with PF will be included in this study after being referred by their 
general practitioner in the North Denmark Region. In addition to the referrals, a Facebook 
post will be made to recruit participants. Participants will have the same eligibility criteria 
and undergo the same screening regardless of the origin of recruitment. Upon contacting 
the primary investigator, a telephone screening will be performed with questions regarding 
the eligibility criteria. If the potential participants appear to be eligible for inclusion they will 
be invited to a clinical examination at the Research Unit for General Practice where final 
eligibility will be confirmed. 
International 
Physical Activity 
Questionnaire 
 
X 
X 
 
X 
Compliance 
 
 
 
 
 
Patient 
Acceptable 
Symptom State 
 
 
 
 
 
Anthropometric 
data 
X 
 
 
 
 
Age 
X 
 
 
 
 
Pain localization 
X 
 
 
 
 
Global Rating of 
Change 
 
 
 
 
X 

 
Methods: Assignment of interventions (for controlled trials) 
 
16a 
Method of generating the allocation sequence (eg, 
computer-generated random numbers), and list of any factors for 
stratification. To reduce predictability of a random sequence, details of 
any planned restriction (eg, blocking) should be provided in a separate 
document that is unavailable to those who enrol participants or assign 
interventions 
The participants will be will be block randomised in block sizes of 2 to 6 (1:1) into 2 parallel 
groups of 35 participants using a random number generator on www.sealedenvelope.com. 
The block sizes will be concealed to the primary investigator and will be stratified by sex. 
 
16b 
Mechanism of implementing the allocation sequence (eg, 
central telephone; sequentially numbered, opaque, sealed envelopes), 
describing any steps to conceal the sequence until interventions are 
assigned 
After the participant has been enrolled the primary investigator will take a sequentially 
numbered opaque sealed envelope in which group allocation has been previously 
determined. 
 
16c 
Who will generate the allocation sequence, who will enrol 
participants, and who will assign participants to interventions 
A researcher not involved in the study will generate the allocation sequence and is the only 
person who knows the block sizes. The primary investigator will enrol participants and 
assign them to the exercise protocols based on their randomisation. 
 
17a 
Who will be blinded after assignment to interventions (eg, trial 
participants, care providers, outcome assessors, data analysts), and 
how 
The participants will be told that the study is about performing an exercise for treating PF 
and that there will be two groups that perform the exercise in different ways. They are not 

informed about the primary outcome of the study or the differences between the training 
programmes.  
 
17b 
If blinded, circumstances under which unblinding is 
permissible, and procedure for revealing a participant’s allocated 
intervention during the trial 
N/A 
 
Methods: Data collection, management, and analysis 
18a 
Plans for assessment and collection of outcome, baseline, 
and other trial data, including any related processes to promote data 
quality (eg, duplicate measurements, training of assessors) and a 
description of study instruments (eg, questionnaires, laboratory tests) 
along with their reliability and validity, if known. Reference to where 
data collection forms can be found, if not in the protocol 
The telephone screening contains questions about age, the duration of pain, history of 
systemic diseases, prior heel surgery, pregnancy, and previous corticosteroid injection for 
PF within the previous 6 months. During the physical examination self-reported data on 
height, weight, leisure time physical activity, previous care-seeking behaviour, mean heel 
pain during the week prior to the examination measured on a 0 to 100 mm VAS (0=no 
pain, 100=worst pain imaginable), pain locations using a pain manikin (42), and sick leave 
will be collected.  
 
18b 
Plans to promote participant retention and complete follow-
up, including list of any outcome data to be collected for participants 
who discontinue or deviate from intervention protocols 
The 4-week follow-up will be planned during baseline and the 12-week follow-up will be 
planned during the 4-week follow-up together with the participants. The participants will be 
contacted by phone, SMS or e-mail one week prior to the follow-ups by the primary 
investigator to remind them of the appointments.  
 

19 
Plans for data entry, coding, security, and storage, including 
any related processes to promote data quality (eg, double data entry; 
range checks for data values). Reference to where details of data 
management procedures can be found, if not in the protocol 
The participants will fill out the questionnaires themselves and the primary investigator will 
impute the answers into the FHSQ software which calculates the score of each domain. 
Data from the ultrasonography will initially be written in paper forms and afterwards 
entered electronically into an Excel spreadsheet. This will be done at the study site where 
data originated. All original paper forms will be kept in a locked cabinet at the study site. All 
data will be kept for 10 years after completion of the study which in accordance with The 
European Code of Conduct for Research Integrity. 
 
20a 
Statistical methods for analysing primary and secondary 
outcomes. Reference to where other details of the statistical analysis 
plan can be found, if not in the protocol 
All statistical analyses will be performed according to a pre-established analysis plan in 
consultation with a statistician. STATA ver. 14 will be used as statistical software. The 
primary intention-to-treat analysis will test the between-group difference in the FHSQ pain 
domain at the 12-week follow-up. In addition to this, between-group comparisons of the 
other FHSQ domains, PSEQ, IPAQ, and plantar fascia thickness will be performed using a 
repeated measures ANCOVA with the outcome as the dependent variable, time (baseline, 
4 weeks and 12 weeks) as the within-subjects factor, group allocation as the between-
subjects factor and the baseline value as the covariate. If any interactions are found, post 
hoc Bonferroni adjustments for multiple comparisons will be made. The between-group 
difference in time to PASS among participants who report PASS, and the number of 
training sessions performed during the trial using independent t-tests. The relative risk 
(RR) will be calculated for the dichotomized GROC to determine the probability of being 
improved and for the dichotomized PASS (Yes/No) to determine the probability of 
achieving a satisfactory result within the 12 weeks of intervention. The difference in mean 
training sessions performed per week from before to after PASS among participants who 
report PASS no later than during week 11 of the intervention will be investigated using a 
paired t-test. The number needed to treat will be calculated as 1/risk difference for the 
primary outcome. The association between the PSEQ score and compliance will be 
investigated using Pearson’s correlation coefficient. 
 
20b 
Methods for any additional analyses (eg, subgroup and 
adjusted analyses) 

N/A 
 
20c 
Definition of analysis population relating to protocol non-
adherence (eg, as randomised analysis), and any statistical methods to 
handle missing data (eg, multiple imputation) 
The analyses will be by the intention-to-treat principle and participants are included in the 
analyses regardless of the exercise compliance they report. 
 
Methods: Monitoring 
21a 
Composition of data monitoring committee (DMC); summary 
of its role and reporting structure; statement of whether it is 
independent from the sponsor and competing interests; and reference 
to where further details about its charter can be found, if not in the 
protocol. Alternatively, an explanation of why a DMC is not needed 
A data monitoring committee will not be established as the exercises are commonly used 
in the population of interest and do not pose a threat to the participants. 
 
21b 
Description of any interim analyses and stopping guidelines, 
including who will have access to these interim results and make the 
final decision to terminate the trial 
The exercises have previously been used for patients with this type of diagnosis. They 
tolerate it well and there will be no stopping rules planned. 
 
22 
Plans for collecting, assessing, reporting, and managing 
solicited and spontaneously reported adverse events and other 
unintended effects of trial interventions or trial conduct 
The participants will be able to report any adverse events to the primary investigator when 
they occur by phone, SMS or e-mail. Expected adverse events are injuries to the 
musculoskeletal system such as a muscle teat, a muscle strain, a sprained joint, injury 
from falling or exacerbation of symptoms related to PF. Adverse events will be graded 1 to 
5 according to the Common Terminology Criteria for Adverse Events v4.03 (43). A medical 

doctor specialised in rheumatology or general practice will assess and grade the adverse 
event and ultimately have the decision whether the participant should be withdrawn from 
the study due to the adverse event. If the adverse event is a grade 1 (mild) the participant 
may be allowed to skip one or two training sessions without any assessment. If the 
adverse event recurs after having skipped the exercise, the participant will have to be 
assessed by the medical doctor before participation in the study is continued. If a 
participant experiences an adverse event and requests withdrawal from the study, data 
until the last exercise activity before the adverse event occurred will be included in the 
analyses. The primary investigator will report any incidents to the sponsor as quickly as 
possible and no later than 15 days after the participant reported the event. Sponsor will 
report any severe adverse events (grade 3-5) to the Ethics Committee of North Denmark 
Region no later than 7 days after being informed. 
 
23 
Frequency and procedures for auditing trial conduct, if any, 
and whether the process will be independent from investigators and the 
sponsor 
N/A 
 
Ethics and dissemination 
24 
Plans for seeking research ethics committee/institutional 
review board (REC/IRB) approval 
The study will be conducted according to the Declaration of Helsinki III and this protocol, 
template informed consent forms and participant information will be approved by the Ethics 
committee of North Denmark Region prior to the inclusion of participants. 
 
25 
Plans for communicating important protocol modifications 
(eg, changes to eligibility criteria, outcomes, analyses) to relevant 
parties (eg, investigators, REC/IRBs, trial participants, trial registries, 
journals, regulators) 
Any modifications to the protocol that will impact the conduct of the study such as study 
objectives, study design, patient population, sample sizes, study procedures or significant 
administrative aspects will be communicated to the Ethics Committee of North Denmark 
Region for approval. The registration on clinicaltrials.gov will be updated if any of the 
abovementioned modifications are made. 

 
26a 
Who will obtain informed consent or assent from potential 
trial participants or authorised surrogates, and how (see Item 32) 
The primary investigator will obtain informed consent by the participants.  
 
26b 
Additional consent provisions for collection and use of 
participant data and biological specimens in ancillary studies, if 
applicable 
N/A 
 
27 
How personal information about potential and enrolled 
participants will be collected, shared, and maintained in order to protect 
confidentiality before, during, and after the trial 
Personal information about potential and enrolled participants will be collected during the 
telephone screening and during allocation. All data will be kept for 10 years after 
completion of the study which in accordance with The European Code of Conduct for 
Research Integrity.  
 
28 
Financial and other competing interests for principal 
investigators for the overall trial and each study site 
The authors declare that they have no competing interests. 
 
29 
Statement of who will have access to the final trial dataset, 
and disclosure of contractual agreements that limit such access for 
investigators 
The primary investigator and all co-authors will have unlimited access to the final data set 
before publication. The data will afterwards be stored in a publicly accessible repository. 
 

30 
Provisions, if any, for ancillary and post-trial care, and for 
compensation to those who suffer harm from trial participation 
Any participants who suffer harm from trial participation will receive compensation by The 
Patient Compensation Association.  
 
31a 
Plans for investigators and sponsor to communicate trial 
results to participants, healthcare professionals, the public, and other 
relevant groups (eg, via publication, reporting in results databases, or 
other data sharing arrangements), including any publication restrictions 
We aim to publish positive, negative or inconclusive results of the study in a peer-reviewed 
journal. The project group will also present results at conferences. The working title of the 
future paper is “The efficacy of a self-managed resistance training protocol versus a 
predetermined resistance training protocol in individuals with plantar fasciopathy during a 
12-week intervention: a randomised controlled superiority trial”. 
 
31b 
Authorship eligibility guidelines and any intended use of 
professional writers 
The definition of author is defined on ICMJE´s four criteria (1):  
 
 
Substantial contributions to the conception or design of the work; or the acquisition, 
analysis, or interpretation of data for the work; AND 
 
Drafting the work or revising it critically for important intellectual content; AND 
 
Final approval of the version to be published; AND 
 
Agreement to be accountable for all aspects of the work in ensuring that questions 
related to the accuracy or integrity of any part of the work are appropriately 
investigated and resolved. 
 
 
31c 
Plans, if any, for granting public access to the full protocol, 
participant-level dataset, and statistical code 
No later than 3 years after the final follow-up, we will deliver a completely anonymised data 
set to an appropriate data archive for sharing purposes. 
 
 
32 
Model consent form and other related 
documentation given to participants and authorised surrogates 

33 
Plans for collection, laboratory evaluation, and storage of 
biological specimens for genetic or molecular analysis in the current 
trial and for future use in ancillary studies, if applicable 
 
 

References 
1.  
International Committee of Medical Journal Editors. Recommendations for the 
Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals 
[Internet]. [cited 2017 Jan 2]. Available from: http://www.icmje.org 
2.  
Hill CL, Gill TK, Menz HB, Taylor AW. Prevalence and correlates of foot pain in a 
population-based study: the North West Adelaide health study. J Foot Ankle Res. 
BioMed Central; 2008 Dec 28;1(1):2.  
3.  
Dunn JE, Link CL, Felson DT, Crincoli MG, Keysor JJ, McKinlay JB. Prevalence of 
Foot and Ankle Conditions in a Multiethnic Community Sample of Older Adults. Am J 
Epidemiol. Oxford University Press; 2004;159(5):491–8.  
4.  
Taunton JE, Ryan MB, Clement DB, McKenzie DC, Lloyd-Smith DR, Zumbo BD. A 
retrospective case-control analysis of 2002 running injuries. Br J Sports Med. BMJ 
Publishing Group Ltd and British Association of Sport and Exercise Medicine; 2002 
Apr 1;36(2):95–101.  
5.  
Lysholm J, Wiklander J. Injuries in runners. Am J Sports Med. American 
Orthopaedic Society for Sports Medicine; 1987 Mar 1;15(2):168–71.  
6.  
Buchbinder R. Plantar Fasciitis. N Engl J Med.  Massachusetts Medical Society ; 
2004 May 20;350(21):2159–66.  
7.  
van Leeuwen KDB, Rogers J, Winzenberg T, van Middelkoop M. Higher body mass 
index is associated with plantar fasciopathy/’plantar fasciitis’: systematic review and 
meta-analysis of various clinical and imaging risk factors. Br J Sports Med. BMJ 
Publishing Group Ltd and British Association of Sport and Exercise Medicine; 2016 
Aug;50(16):972–81.  
8.  
Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, et 
al. Plantar fascia-specific stretching exercise improves outcomes in patients with 
chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone 
Joint Surg Am. 2006 Aug;88(8):1775–81.  
9.  
Rathleff MS, Mølgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, et al. 
High-load strength training improves outcome in patients with plantar fasciitis: A 
randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015 
Jun;25(3):e292-300.  
10.  Davis PF, Severud E, Baxter DE. Painful Heel Syndrome: Results of Nonoperative 
Treatment. Foot Ankle Int. SAGE PublicationsSage CA: Los Angeles, CA; 1994 
Oct;15(10):531–5.  
11.  van Ark M, Cook JL, Docking SI, Zwerver J, Gaida JE, van den Akker-Scheek I, et 
al. Do isometric and isotonic exercise programs reduce pain in athletes with patellar 
tendinopathy in-season? A randomised clinical trial. J Sci Med Sport. 2016 
Sep;19(9):702–6.  
12.  Desmeules F, Boudreault J, Dionne CE, Frémont P, Lowry V, MacDermid JC, et al. 

Efficacy of exercise therapy in workers with rotator cuff tendinopathy: a systematic 
review. J Occup Health. 2016 Sep 30;58(5):389–403.  
13.  Rathleff MS, Thorborg K. “Load me up, Scotty”: mechanotherapy for plantar 
fasciopathy (formerly known as plantar fasciitis). Br J Sports Med. 2015 May 
1;49(10):638–9.  
14.  Malliaras P, Barton CJ, Reeves ND, Langberg H. Achilles and Patellar Tendinopathy 
Loading Programmes. Sport Med. Springer International Publishing AG; 2013 Apr 
15;43(4):267–86.  
15.  Coombes BK, Bisset L, Brooks P, Khan A, Vicenzino B, H O, et al. Effect of 
Corticosteroid Injection, Physiotherapy, or Both on Clinical Outcomes in Patients 
With Unilateral Lateral Epicondylalgia. JAMA. American Medical Association; 2013 
Feb 6;309(5):461.  
16.  Littlewood C, Bateman M, Brown K, Bury J, Mawson S, May S, et al. A self-
managed single exercise programme versus usual physiotherapy treatment for 
rotator cuff tendinopathy: a randomised controlled trial (the SELF study). Clin 
Rehabil. SAGE PublicationsSage UK: London, England; 2016 Jul 1;30(7):686–96.  
17.  Beyer R, Kongsgaard M, Hougs Kjær B, Øhlenschlæger T, Kjær M, Magnusson SP. 
Heavy Slow Resistance Versus Eccentric Training as Treatment for Achilles 
Tendinopathy. Am J Sports Med. SAGE PublicationsSage CA: Los Angeles, CA; 
2015 Jul;43(7):1704–11.  
18.  Kongsgaard M, Kovanen V, Aagaard P, Doessing S, Hansen P, Laursen AH, et al. 
Corticosteroid injections, eccentric decline squat training and heavy slow resistance 
training in patellar tendinopathy. Scand J Med Sci Sports. Blackwell Publishing Ltd; 
2009 Dec;19(6):790–802.  
19.  McLean SM, Burton M, Bradley L, Littlewood C. Interventions for enhancing 
adherence with physiotherapy: A systematic review. Man Ther. 2010;15(6):514–21.  
20.  Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in 
physiotherapy outpatient clinics: a systematic review. Man Ther. Elsevier; 2010 
Jun;15(3):220–8.  
21.  David Moher 1, Sally Hopewell, 2 Kenneth F Schulz, 3 Victor Montori, 4 Peter C 
Gøtzsche, 5 P J Devereaux 6 Diana, Elbourne 7, Matthias Egger 8 Douglas G 
Altman2 1Ottawa. RSOT 527 Critical Review Assignment Winter 2014 Dr. Zwicker 1. 
2014;1–2.  
22.  Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better 
reporting of interventions: template for intervention description and replication 
(TIDieR) checklist and guide. BMJ. 2014;348(mar07 3):g1687.  
23.  Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group. Methods 
and processes of the CONSORT Group: example of an extension for trials 
assessing nonpharmacologic treatments. Ann Intern Med. 2008 Feb 19;148(4):W60-
6.  

24.  Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J a, et al. SPIRIT 
2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 
2013;346:e7586.  
25.  Bandholm T, Christensen R, Thorborg K, Treweek S, Henriksen M. Preparing for 
what the reporting checklists will not tell you: the PREPARE Trial guide for planning 
clinical research to avoid research waste. Br J Sports Med. 2017 Sep 7;bjsports-
2017-097527.  
26.  McMillan AM, Landorf KB, Gilheany MF, Bird AR, Morrow AD, Menz HB. Ultrasound 
guided corticosteroid injection for plantar fasciitis: randomised controlled trial. BMJ. 
British Medical Journal Publishing Group; 2012;344(21):e3260.  
27.  Toigo M, Boutellier U. New fundamental resistance exercise determinants of 
molecular and cellular muscle adaptations. Eur J Appl Physiol. 2006;97(6):643–63.  
28.  Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a 
questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 
1998 Sep 1;88(9):419–28.  
29.  Landorf KB, Radford JA. Minimal important difference: Values for the Foot Health 
Status Questionnaire, Foot Function Index and Visual Analogue Scale. Foot. 
Elsevier; 2008 Mar;18(1):15–9.  
30.  Hagell P, Hedin P, Meads DM, Nyberg L, McKenna SP. Effects of Method of 
Translation of Patient‐Reported Health Outcome Questionnaires: A Randomized 
Study of the Translation of the Rheumatoid Arthritis Quality of Life (RAQoL) 
Instrument for Sweden. Value Heal. Blackwell Publishing Inc; 2010 Jun 1;13(4):424–
30.  
31.  Skovdal Rathleff M, Moelgaard C, Lykkegaard Olesen J. Intra- and interobserver 
reliability of quantitative ultrasound measurement of the plantar fascia. J Clin 
Ultrasound. Wiley Subscription Services, Inc., A Wiley Company; 2011 
Mar;39(3):128–34.  
32.  Tubach F, Ravaud P, Martin-Mola E, Awada H, Bellamy N, Bombardier C, et al. 
Minimum clinically important improvement and patient acceptable symptom state in 
pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, 
hand osteoarthritis, and hip and knee osteoarthritis: Results from a prospective 
multina. Arthritis Care Res (Hoboken). John Wiley & Sons, Inc.; 2012 
Nov;64(11):1699–707.  
33.  Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, et al. Evaluation of 
clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: 
the patient acceptable symptom state. Ann Rheum Dis. BMJ Publishing Group Ltd; 
2005 Jan;64(1):34–7.  
34.  Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, et al. Measuring 
acute postoperative pain using the visual analog scale: the minimal clinically 
important difference and patient acceptable symptom state. BJA Br J Anaesth. 
Oxford University Press; 2017 Mar;118(3):424–9.  

35.  Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J 
Pain. Blackwell Publishing Ltd; 2007 Feb 1;11(2):153–63.  
36.  Rasmussen MU, Rydahl-Hansen S, Amris K, Samsøe BD, Mortensen EL, 
Mortensen EL. The adaptation of a Danish version of the Pain Self-Efficacy 
Questionnaire: reliability and construct validity in a population of patients with 
fibromyalgia in Denmark. Scand J Caring Sci. 2016 Mar;30(1):202–10.  
37.  van Poppel MNM, Chinapaw MJM, Mokkink LB, van Mechelen W, Terwee CB. 
Physical Activity Questionnaires for Adults. Sport Med. Springer International 
Publishing; 2010 Jul;40(7):565–600.  
38.  Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, et al. 
International physical activity questionnaire: 12-country reliability and validity. Med 
Sci Sports Exerc. 2003 Aug;35(8):1381–95.  
39.  Cotchett MP, Munteanu SE, Landorf KB. Effectiveness of Trigger Point Dry Needling 
for Plantar Heel Pain: A Randomized Controlled Trial. Phys Ther. Oxford University 
Press; 2014 Aug 1;94(8):1083–94.  
40.  Landorf KB, Keenan A-M, Herbert RD. Effectiveness of Foot Orthoses to Treat 
Plantar Fasciitis. Arch Intern Med. American Medical Association; 2006 Jun 
26;166(12):1305.  
41.  Radford JA, Landorf KB, Buchbinder R, Cook C. Effectiveness of low-Dye taping for 
the short-term treatment of plantar heel pain: a randomised trial. BMC Musculoskelet 
Disord. BioMed Central; 2006 Aug 9;7:64.  
42.  van den Hoven LHJ, Gorter KJ, Picavet HSJ. Measuring musculoskeletal pain by 
questionnaires: The manikin versus written questions. Eur J Pain. European 
Federation of International Association for the Study of Pain Chapters; 
2010;14(3):335–8.  
43.  Common Terminology Criteria for Adverse Events (v4.03). U.S.Department of Health 
and Human Services; 2010.