"When Movement Moves" - A Self-controlled Trial of the Physiological, Mental and Social Health Benefits Among Individuals With Low Physical Mobility Moved by Others in Two Existing Initiatives: the Danish Team Twin and Cycling Without Age
Phase: NA
Conditions: Physical Disability, Healthy
Sponsor: University of Southern Denmark

5th August - 2021
"When Movement Moves" - The Health Benefits Among Individuals With Low 
Physical Mobility Moved by Others (WMM) 
ClinicalTrials.gov ID: NCT04536779 
The Ethics Committee of the Capital Region of Denmark (Human subjects protection review board) 
Journal-number.: H-20010668 (Date: 13th October 2020) 

Study protocol 
 
Title: "When Movement Moves" - The Health Benefits Among 
Individuals With Low Physical Mobility Moved by Others (WMM) 
 
Background   
 
Elderly and individuals with functional disabilities often face multiple personal and environmental barriers 
reducing their ability to engage and participate in physical and social activities [1-5]. Increasing age and 
level of disability correlates with lower levels of physical activity (PA), and an increased prevalence of 
chronic and cardiovascular diseases [6-11], which can result in premature death [12-15]. Contemporary 
literature indicates a dose-response relationship between PA and promotion of all health outcomes: the 
greatest risk reduction comes with higher intensities of PA [16], thus, PA serves as disease prevention and 
health maintenance [6, 17]. Moreover, the World Health Organisation encourages  elderlies and disabled, 
regardless of age or impairments, to perform any kind of PA, as ‘some is better than nothing’[18]. 
Additionally, a recent review indicates that less PA than the recommended can enhance health outcomes 
among persons with a disability [19]. Moreover, a recent study has linked various alternative forms of PA 
and therapy to be beneficial for health promotion and rehabilitation among individuals with cerebral palsy 
(CP) [20]. The literature further indicates that PA can promote cognitive function among the elderly [21] 
and cognitively disabled [22] on top of the well-known physiological benefits of PA. Elderly and disabled 
persons participating in adapted sports experience an increase to mental and social health factors, e.g., 
decreased feelings of loneliness, increased feelings of self-efficacy [23], autonomy and well-being [24, 25] 
and improvements in quality of life (QoL) [25-29]. Social support is identified as a crucial facilitator of the 
disabled and elderly’s participation in PA [30]. Prior studies, however, have mainly focused on individuals 
with spinal cord injuries or elderly who can participate in (elite)sport and PA by themselves, despite a 
disability [24, 27, 31] or physical limitations due ageing [32]. There is a lack of literature on the frailest 
individuals in these groups, who are unable to participate in most kinds of PA. The few studies available 
have low external (i.e generalisability) validity [27, 33]. Pilot studies investigating indirect PA (defined as an 
activity where a person unable to partake in physical activity on their own, is joined by someone who is 

able, and together partake in PA) in the disabled [34] and elderly [35-40] populations exist, however, and 
these report promising effects of indirect PA on all health outcomes and QoL 
Despite the existence of pilot studies, little is known about the physical, mental and social health benefits 
of participation in indirect PA in a social context. Programmes (interventions/initiatives) providing indirect 
PA may motivate and promote participation if (some of) the same health benefits derived from PA can be 
attained through indirect PA, which may in turn result in improved QoL of the elderly and disabled. 
Therefore, the research project “When Movement Moves” (WMM) evaluates the pre-existing Danish 
programmes: Team Twin (TT) and Cycling Without Age (CWA) as both programmes make use of volunteers 
to assist indirect PA in disabled individuals and the elderly, respectively, using equipment designed for the 
purpose. The programmes ultimately share the same goal: enhancement of QoL and promotion of physical, 
social and mental health achieved through indirect PA in a social context [41, 42]. 
Aim  
The overall hypothesis is that the activities delivered by Team Twin and Cycling Without Age increase the 
quality of life of the participants who are moved through others. The purpose of the trial is to investigate 
the physiological, mental, social health effect among individuals with low physical mobility participating in 
one of the two pre-existing initiatives: the Danish 'Team Twin' and Cycling Without Age. In these, the 
individuals with low physical mobility are moved by and together with normal functioning volunteers. 
Furthermore, we will investigate the importance of being a volunteer runner and pilot, relatives of and care 
staff for disabled athletes and the elderly. 
 
Based on the above, this research project will answer the following research questions: 
 
1. Does movement by others improves the quality of life (QOL) among individuals with low physical 
mobility 
2. Does movement by others improves the physiological health among individuals with low physical 
mobility 
3. Does moving individuals with low physical mobility improve health among normal functioning 
individuals (i.e volunteer runners and pilots)? 
4. How does participation in the physical activity initiatives influence well-being, relations and 
attitudes among relatives (to the disabled individuals) and employees at nursing homes? 
 
 

Design and Methods  
Settings 
The WMM-project will be conducted in collaboration with the local departments of Team Twin (TT) and 
Cycling Without Age (CWA).  
The Team Twin association 
The TT association is the overall umbrella-organization for the sports and inclusion concept “Team Twin – 
We run Together”. It was established in the year of 2014. Since then, the TT association have grown, and 
the association now has local departments established all over Denmark with the biggest local department 
located in Copenhagen with approximately 100 members [43]. The total amount of local department has 
grown to nine since the beginning and has over 400 members in varied age, disabled and non-disabled, 
women, men, adolescence and adults (for an overview of the organization chart of the Team Twin 
association see figure 1). The intensity, exercises (triathlete inspired), and duration can vary from club to 
club and according to time of the season. Handicap Athletes and voluenteers, so called runners, are 
expected to participate in a minimum of 8-10 training sessions during the trial period, which is a minimum 
of 3 months. In the period from Oktober 2020  to January 2021, two-three new local departments are 
expected to be established. In close cooperation between Team Twin and Institute of Public Health , 
Uiversity of Southern Denmark (SDU), we will seek out to recruit  the recent members of the latest 
established local departments of TT.  
The details of times and investigations will be determined in collaboration with the local associations and 
with regard to planned training courses and possible participation in competitions. 
 
Cycling Without Age 
Cycling Without Age is a worldwide association started up in Denmark, whose mission is to give the elderly 
"the right to wind their hair". Volunteers, so-called pilots, cycle elderly people, so called passengers, with 
low level of mobility  in rickshaws on shorter or longer trips. The primary purpose is to give senior citizens a 
feeling of joy and give them the opportunity to remain an active part of the community. In Denmark, there 
are more than 7,000 volunteer pilots across 430 locations, typically care centers, with a total of 500 
rickshaws. In 2018, a total of 14,877 registered bicycle trips were made [42]. 
A minimum of 6-8 bicycle trips during the intervention period, which is a minimum of 3 months, is, 
however, assumed to be necessary in order to be able to attribute the effect to the intervention. The 

details of times and examinations will be determined in collaboration with the local care centers and any 
planned bicycle trips. 
 
Theoretic framework for evaluation  
The programme theory Illustrates the causal chain, which explains the hypothesis of how the intervention 
components of the Team Twin and Cycling Without Age are expected to impact the participants quality of 
life by participating in one of the two components (Figure 1).  
 
 
 
Figure 1 Overall program theory for WMM-study 

Quality of life is a broad concept, and there are many different definitions, all of which include dimensions 
of physical, social and mental health. The World Health Organization (WHO) defines quality of life as: “..an 
individual's perception of their position in life in the context of the culture and value systems in which they 
live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept 
affected in a complex way by the person's physical health, psychological state, personal beliefs, social 
relationships and their relationship to salient features of their environment.”[44] Qualilty of life will be 
elucidated from different angles and examined by different quantitative and qualitative methods such as 
through a) scientific methods in the form of physiological measurements and physical tests b) 
questionnaires and c) interviews and observations. 
 
Study designs 
The WWM-study consists of different parts and each part has its own approach, methods and measures, 
which will be described below. Prior to the data collection, we will pilot test our questionaries, interview- 
and observation guides for the potential adjustments according to the data collection methods. Further, we 
will conduct a minor pilot test of the laboratory protocol with 1-2 Handiathletes affiliated in an existing 
local department of Team Twin. The study has been reported to the Danish National Committee on Health 
Research Ethics Journal-nr.: H-20010668 ().             
The target groups of the WMM trial are: 1) Handiathletes (Team Twin) and Passengers (Cycling Without 
Age and 2) the volunteer persons called “Runners” (TT) and “pilots” (CWA), who are the persons who move 
the diabled, Relatives (i.e. parents and siblings of the Handiathletes and 4) Nursing Staff (e.g. NS working at 
a care home, disabled carer or disabled escort for elderlies). The disabilities among the Handiathletes varies 
but the three most common are 1) cerebral palsy, 2) muscular dystrophy and 3) non-specific inherent faulty 
genes. Amog the elderly, it will mainly be age-related mobility decline however, also some decrease in 
cognitive functioning occurs among some of the participants. 
 
 
Sub-study 1. Team Twin 
Study design: Self-controlled before and after study. We do not consider it practically possible to carry out 
a study with a control group due to the relatively modest number of new members in the association. 
Target group: Handiathletes (n=25) and runners (n=25). For the explorative study, inteviews will be 
conducted with Handiathletes (n=4-6) and runners (n=4-6). Also, relatives will be included in focus group 
interviews (n = 4-7). 

Methods: Physiological measurements and questionnaire with three measurement points. Twice before 
the start of the training course and once immediately after the end of the training course. This means that 
the individual participant acts as his or her own control. This sub study consist of two parts 1) a pre-post 
short-term effect evaluation; and 2) an explorative study guided by the program theory, in which examine  
how, why and what has an impact on mental and social health.   
Study period: The baseline measure for this substudy is medio February 2021 (before the training season), 
and follow-up measurements will be conducted four months later in ultimo June.  
Primary outcomes: Quality of Life for Handiathletes and secondarily the physiological effects.  
Measurements:  
Selfreported Questionaire (Handi Athletes, Runners and relatives): Quality of Life will be measured by 
questionnaire. For detailed information on the questionnaire, see the measurements section below.  
Weekly text-message (SMS) (Handiathletes and Runners): registration of perceived well-being and quality of 
life. 
Movement sensors (Handiathletes and Runners): Heart rate registration (GARMIN-watch). Runners will be 
informed, and trained in the use of the technology. The a GARMIN-watch will be attached to the wrist of 
the Handiathletes to quantify the level of physical activity during training and races throw the trial period. 
Further, the Garmin-watch will monitor the quality of sleep for one week in the trial period.      
Clinical test (Handiathletes only): 1) Dual x-ray absorptiometry (DXA -scan) for measure change in body 
composition (body fat and lean mass), 2) Blood samples for measuring the metabolic change including; 
serum concentration of cholesterols, triglycerides, glucose, C-peptide, insulin and HbA1c, haematology, 
electrolytes, metabolites, liver- and renal status, endocrinology (including HCG if relevant) and markers of 
immune function/inflammatory, 3) Oral glucose tolerance test (OGTT) will be performed for screening the 
glucose level (metabolism inflammation: plasma- LDL, HDL, TG, TC, fasting insulin, C-peptide and glucose), 
4) Blood volume (BV) status will be conducted to investigate the training effects on central underlying 
mechanisms of cardiorespiratory fitness, namely, total BV, plasma volume (PV) and haemoglobin mass 
(Hbmass).  
 
Interviews (Focusgroup and single interviews) and observations: For detailed information on the interviews 
and observations, see the measurements section below. 

 
Overview of activities taking place during the TT subproject of WMM 
 
 

Sub-study 2 – Cycling without age 
Study design: Before and after evaluation of the Cycling Without Age activities on Quality of life using 
matching-adjusted indirect comparison between elderlies enrolled with the activities and elderlies not 
enrolled. This design is chosen, as randomization is not considered a realistic option in this real world 
pragmatic trial.  
Target group: Passengers (Elderlies at nursing homes) (n=aprrox. 100 in the ‘intervention group’)) and 
piltos (n=approx. 100). In close collaboration with the association Cycling Without Age, we will recruit 
participants for the research project. We will strive to include older people who have not previously 
participated in activities with Cycling Without Age. 
 
Methods: Selfreported questionnaire before and after the activities (at least two measuremnets). We will 
monitor whether it is possible to observe a dose-response relationship eg. Duration and distance. 
Study period: The baseline measure for this substudy is spring 2021.  
Primary outcomes: Quality of Life for elderlies. Secondary outcomes: mental, physical, and social health. 
(See program theory) 
Measurements: 
This section will explain the characteristics of the material and instruments used to conduct a quantitative 
investigation of the Cycling Without Age subproject. 
Objective Functional and Cognitive Appraisal: A test battery will be conducted pre and post on-site at the 
participants’ residence to evaluate a change in cognitive and physical function among nursing home 
residents. Cognitive function Brief Assessment of Impaired Cognition Questionnaire (BASIC-Q). A simple and 
newly invented tool for practitioners and healthcare professionals was selected to assess a possible change 
in the cognitive function level of the nursing home residents 
Physical Function and Mobility: To evaluate physical performance and a possible change frompre to post, 
various physical tests were selected. Our test battery includes (1) the Short Physical Performance Battery, 
(2) the 4 m gait speed test and (3) the 6-min walking test (6MWT). The battery is performed on-site, where 
the nursing home resident lives, following recommended guidelines and standard procedures for each test 
[75,76]. All the tests are highly recommended in research and used among elderlies to detect functional 
capacity and sarcopenia symptoms. The chosen tests have shown great validity and reliability [77]. 

Muscle Strength; Muscle strength will be evaluated with (1) the chair and stand test (which is incorporated 
in SPPB) and (2) handgrip strength. The grip-strength measure is performed three times with a 1-min 
interval between each attempt. The attempt with the highest score (measured in kilograms) will count as 
the final. 
Power Calculation   
Based on a Danish Ph.D. project from 2019 [45], our study should include a minimum of 19 Handi Athletes, 
to detect a 10% increased effect in the main outcome (Quality of Life) (effect size 10%, absolute change 
0.66, standard deviation 1.0, strength (beta): 0.8, alpha: 0.05). However, the WMM-study aim to recruit 
more than 19 Handiathletes to participate in the questionnaire (Sub study 2 and 3).     
 
 

 
Overview of activities taking place during the CWA sub-project of WMM

Data collection methods 
Questionaries   
The questionaries are mainly based on validated measures (i.a. Cantril Ladder of Life Scale WHOQOL-
disability modul, WHO-5 and (S)WEMWBS), further, it will be supplemented with items from other studies 
including EQOL[45] and SHILD[46]. “Cantrills Ladder” is used and validated in a lot of studies as a simple 
way to ask people to rate their current satisfaction with life - or happiness from a scale from 0-10 (where 10 
is the best and most satisfying life you can have, and 0 I vice versa)[47]. Therefore, this scale is expected to 
a validated measure tool that can be used among many different target groups – including WMM. 
New items will be developed especially related to the WMM-Study to uncover the study hypothesizes. The 
questionnaires will cover themes in the overall and taget group specific program theory. The questionnaire 
will be developed among the research group, expert group and internal colleagues who have research 
experience with the target group.  
 
The questionnaire for the Runners and pilots seeks to measure the volunteers Qulaity of life and the 
underlying sub-themes according to Quality of Life. The questionnaire will be developed by the research 
group and will seek inspiration from other studies i.e the ABC-mental health study[48]. The questionnaire 
will cover the following themes: QOL, life satisfaction, Identity self-assessed health, Physical activity and 
social cohesion, welfare, voluntariness, value & importance. Also the questionaire to the relatives and the 
Nursing staff will cover the following some of the above menstioned themes.  
 
Observations  
For each of the sub study we observe 6-8 activities, where we cycle and run with the participants to get 
insight into how the activities proceed, the effects on mood and on how the participants interact. Insights 
from the participant observations are expected to feed into the subsequent interviews with the 
participants and give us a unique opportunity to follow up on specific elements, episodes and participant 
reactions in the courses. Participant observation is particularly well suited to examining social processes 
and concrete interactions and participant reactions in situ. 
 
Interviews 
To obtain the participants' descriptions of their experiences, qualitative interviews will be conducted with 
the disabled athletes (n = 4-6) and the runners (n = 4-6) (Team Twin) as well as with the passengers (n = 4-
6) and pilots (n = 4-6) (Cycling Without Age). The interviews are conducted 4-5 weeks after the beginning of 
the activities using semi-structured, individual interviews, which are suitable for exploratory studies, where 

the informants' experiences, perspectives, reasoning and ways of talking about the phenomenon under 
investigation are in focus. 
 
Also, four focus group interviews will be conducted (n = 4-7) with relatives and caregivers. Focus group 
interviews are suitable for shedding light on different experiences and perspectives on a given research 
topic.  
 
For all interviews, an interview guide is developed based on the research questions and adapted to the 
target group. Recruitment of the participants and sampling takes place in collaboration with Team Tvilling 
and Cycling Without Age associations. The empirical material (transcripts of interviews and field notes) is 
analyzed according to general principles of qualitative analysis. 
 
Trial period and Organization  
The project will be coordinated from 2020 to 2023 by the Center for Intervention Research at the National 
Institute of Public Health, SDU. The National Institute of Public Health has set up an interdisciplinary project 
group that has extensive experience with research into physical activity as well as mental health and quality 
of life, including the importance of meaningful communities. Acitivities will be carried out in close 
collaboration with the Team Twin and the Cycling Without Age associations. TrygFonden's Centre for 
Physical Activity Research (CFAS) is included as a project partner and will be responsible for the laboratory 
testing of people with physical disabilities.  
 
Founding  
The study is founded by financial support from the Bevica Foundation (2.5 mill DKK) and Helsefonden (2.5 
mill DKK). 
 
Ethics Consideration 
The WMM study s will be registered in the Danish research ethics committee and data protection agency 
(awaiting number of registration). It will be guided and reported in accordance to the CONSORT declaration 
(Consolidated Standards of Reporting Trials). The trial will follow the European General Data Protection 
Regulation (GDPR), and the guidelines from the “Danish Council for Independent Research”. Regarding the 
target group, the project will take their different condition in for consideration at all stages of the project.  
 
 

Statistical Analysis Plan (SAP)  
Changes from pre to post  in mean score of QoL, measured using Cantril’s Ladder [47, 49], will be the 
primary statistical outcome measure. Secondary outcomes will include sleep, well-being, loneliness and 
autonomy, as these were identified, during our design phase, to be essential factors for the target groups. 
In addition, changes in the objective measures (clinical examination and physical function test) will also be 
conducted for each target group.  For descriptive statistics and to inform participant characteristics, we 
plan to use paired t-tests and chi-square tests. We furthermore intend to conduct regression analyses, 
using a mixed method approach to compare pre and post messures. Analyses will be performed as per-
protocol and after the intention-to-treat principle, which, in this case, means that potential dropouts (with 
incomplete data) are included in the analyses. Per-protocol participants are defined as participants who 
have participated in a minimum of eight TT or CWA-activities in the period from pre to post measurements 
. The analyses will be adjusted for sociodemographic factors such as sex, age and educational level. Data is 
analysed using significance levels of p=0.05 and 95% confidence intervals. Analyses will be completed by 
Stata Software (StataCorp LP, College Station, Texas). 
 
Outcomes measures and approaches 
Sub-study 1. Team Twin  
Outcomes and measures in the Team Twin evaluation 
 
Measurement 
(outcome) 
What (operational) 
How (instrument) 
When 
(timing of 
collection) 
Who in CWA 
(Data source) 
PRIMARY OUTCOME 
Quality of life (QoL) 
Cantril Ladder of Life Scale 
[49] 
  
Web- and interview-
based questionnaire 
  
Baseline, follow-up 
Passengers, Pilots, 
Nursing staff  
 
 
SECONDARY OUTCOMES 
Autonomy 
The perceived feeling of  
being in control over ones   
own life 
Web-based 
questionnaire 
 
Baseline, follow-up 
Passengers  
Sleep 
Sleep quality and sleep  
quantity   
Web-based 
questionnaire 
 
Baseline, follow-up 
Passengers, Pilots, 

Measurement 
(outcome) 
What (operational) 
How (instrument) 
When 
(timing of 
collection) 
Who in CWA 
(Data source) 
Well-being 
CUA: Warwick- 
Edinburgh Mental  
Well- Being Scale 
(S)WEMWBS) [50, 51] 
 
Web-based 
questionnaire 
 
Baseline, follow-up 
Passengers, Pilots  
Loneliness 
A perceived feeling of  
loneliness and lack of  
network and support [52, 
53] 
Web-based 
questionnaire 
 
Baseline, follow-up 
Passengers, Pilots 
EXPLORATIVE OUTCOMES 
Self-perceived  
health  
Subjectively perceived  
Health [54] 
Web-based 
questionnaire 
Baseline, follow-up 
Passengers, Pilots,  
Perceived pain 
 
Mental and physical  
pain/discomfort [54] 
Web-based 
questionnaire 
Baseline, follow-up 
Passengers, pilots 
Self-perceived  
Physical performance 
Subjectively perceived  
Physical performance 
[55]  
Web-based 
questionnaire 
Baseline, follow-up 
Passengers, pilots 
Self-efficacy  
General self-efficacy [56, 
57]   
Web-based 
questionnaire 
 
Baseline, follow-up 
Passengers, pilots 
Self-worth 
Perceived feeling of  
Acceptance [45]  
Web-based 
questionnaire 
 
Baseline, follow-up 
Passengers, pilots 
Autonomy 
The perceived feeling of  
being in control over ones   
own life 
Web-based 
questionnaire 
 
Baseline, follow-up 
Passengers, pilots 
Social/emotional 
support and network 
Contact and support with 
friends, family and others.  
The perceived feeling of  
being valued, respected  
and accepted by others 
[54] 
Web-based 
questionnaire 
 
Baseline, follow-up 
Passengers, pilots 
 
UNINTENDED SIDE EFFECTS 
Fatigue 
The perceived feeling of  
fatigue related to  
voluntariness or  
programme activity 
Web-based 
questionnaire 
Follow-up 
Passengers, pilots 
Anxiety 
The perceived feeling of  
anxiety trigged by the  
programme activity  
Web-based 
questionnaire 
Follow-up 
Passengers, pilots 

Measurement 
(outcome) 
What (operational) 
How (instrument) 
When 
(timing of 
collection) 
Who in CWA 
(Data source) 
Injuries  
Amount of injuries by  
participation  
Web-based 
questionnaire 
Follow-up 
Passengers, pilots 
 
Objective functional and cognitive level (only for CWA; Passengers) 
Cognitive function 
Brief Assessment of  
Impaired Cognition  
Questionnaire (BASIC-Q)  
[58, 59] 
Interview based case-
findings survey 
Baseline, follow-up 
Passengers    
Physical function and  
mobility 
Short Physical  
Performance Battery  
(SPPB) [60, 61] 
Functional and 
physical test 
Baseline, follow-up 
Passengers   
Muscle Strength 
Grip Strength [62]  
Physical test  
Baseline, follow-up 
Passengers 
Gait endurance 
6-Minute Walk Test [63, 
64] 
Functional test 
Baseline, follow-up 
Passengers  
 
Trip registration for CWA  
Objective observational 
data from every 
training/trip 
- Date (DD-MM-YYYY) 
- Duration (HH:MM) 
- Length (KM) 
- Participants (first name) 
- Environment of activity 
(e.g., park, forest, lake, 
urban) 
- Weather 
- Social activities 
(eat/drink) 
- Destination(s) 
- Mood 
- Overall satisfaction 
Online trip 
registration 
 
(QR-code directing 
users to a short web-
based questionnaire 
is scanned 
immediately after the 
TT or CWA- activity) 
During the 
programme  
 
After finishing a CWA-
activity. 
Context related 
data completed by 
one person after 
each activity 
 
Passengers  
pilots  
 
 
 
 

Sub-study 2. Cycling without age  
Outcome and measures in the Cycling Without Age evaluation. 
 
Measurement 
(outcome) 
What (operational) 
How (instrument) 
When 
(timing of collection) 
Who 
(Data source) 
PRIMARY OUTCOME 
Quality of life (QOL) 
Cantril Ladder of Life Scale 
[49] 
  
Web and interview-
based questionnaires 
  
Baseline, follow-up 
 
 
 
HA, Runners, 
Relatives 
 
 
 
SECONDARY OUTCOMES 
Autonomy 
The perceived feeling of  
being in control over ones   
own life 
Web-based 
questionnaire 
 
Baseline, follow-up 
HA 
 
Sleep 
Sleep quality and sleep  
quantity   
Web-based 
questionnaire 
Bio tracking (HA) 
SMS-Survey (HA) 
Baseline,  
during (HA),  
follow-up 
HA  
Runners 
Well-being 
WHO-five Well-being 
Index [65]  
 
 
Web-based 
questionnaire 
 
Baseline, follow-up 
HA, Runners 
 
Loneliness 
A perceived feeling of  
loneliness and lack of  
network and support [52, 
53] 
Web-based 
questionnaire 
 
Baseline, follow-up 
HA, Runners 
EXPLORATIVE OUTCOMES 
Self-perceived  
health  
Subjectively perceived  
Health [54] 
Web-based 
questionnaire 
Baseline, follow-up 
HA, Runners 
 
Perceived pain 
 
Mental and physical  
pain/discomfort [54] 
Web-based 
questionnaire 
Baseline, follow-up 
HA 
Self-perceived  
Physical performance 
Subjectively perceived  
Physical performance 
[55]  
Web-based 
questionnaire 
Baseline, follow-up 
Runners 
Epileptic seizures 
Reduced epileptic seizures  
(adjusted version[66]) 
Paper-based 
questionnaire 
Baseline, follow-up 
HA 
Self-efficacy  
General self-efficacy [56, 
57]   
Web-based 
questionnaire 
 
Baseline, follow-up 
HA, Runners 
 

Measurement 
(outcome) 
What (operational) 
How (instrument) 
When 
(timing of collection) 
Who 
(Data source) 
Self-worth 
Perceived feeling of  
acceptance [45]  
Web-based 
questionnaire 
 
Baseline, follow-up 
HA, Runners 
 
Social/emotional 
support and network 
Contact and support with 
friends, family and others.  
The perceived feeling of  
being valued, respected  
and accepted by others 
[54] 
Web-based 
questionnaire 
 
Baseline, follow-up 
HA 
 
UNINTENDED SIDE EFFECTS  
Fatigue 
The perceived feeling of  
fatigue related to  
voluntariness or  
programme activity 
Web-based 
questionnaire 
Follow-up 
HA, Runners 
 
Anxiety 
The perceived feeling of  
anxiety trigged by the  
programme activity  
Web-based 
questionnaire 
Follow-up 
HA, Runners 
 
Injuries  
Amount of injuries by  
participation  
Web-based 
questionnaire 
Follow-up 
HA, Runners 
 
Objective clinical data (only for HA:TT) 
Body anthropometrics 
- Bodyweight 
- Body mass index 
- Whole body lean body 
mass 
- Whole body fat mass 
- Whole body bone 
mineral density 
Dual X-ray 
absorptiometry 
B1, B2 + FU 
HA 
 
Clinical blood samples 
Blood glucose control: 
- HbA1c 
- Fasting glucose 
- Fasting C-peptide and 
insulin 
Standard clinical 
procedure  
B1, B2 + FU 
HA 
Blood lipids: 
- Total cholesterol 
- Triglyceride 
Oral Glucose  
Tolerance  
Test (OGTT) 
Glucose,  
C-peptide,  
Insulin  
Standard OGTT-
procedure 
B1, B2 + FU 
HA 
 

Measurement 
(outcome) 
What (operational) 
How (instrument) 
When 
(timing of collection) 
Who 
(Data source) 
Fitness level 
Blood volume 
Estimated from 
haematocrit level 
B1, B2 + FU 
HA 
Office blood pressure 
Resting systolic and  
diastolic blood  
pressure (pulse) 
Monitored by a 
standard procedure 
for office blood 
pressure 
B1, B2 + FU 
HA 
Trip registration 
Objective 
observational data 
from every 
training/trip 
- Date (DD-MM-YYYY) 
- Duration (HH:MM) 
- Length (KM) 
- Participants (first name) 
- Environment of activity 
(e.g. park, forest, lake, 
urban) 
- Weather 
- Total number of 
participants (runners 
and HA) 
- Destination(s) 
Overall satisfaction 
Online trip 
registration 
 
(QR-code directing 
users to a short web-
based questionnaire 
is scanned 
immediately after 
the TT or CWA- 
activity) 
During the programmes 
and after finishing a 
programme activity. 
Context related 
data completed by 
one person after 
each activity 
 
TT: Runners fulfil 
the online form 
 
 
References  
1. 
WHO, World report on disability 2011. 2011, World Health Organization: World Health 
Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland. 
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