Clinical trial NCT04536779: "When Movement Moves" - The Health Benefits Among Individuals With Low Physical Mobility Moved by Others
Official title: "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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Healthy
Keywords: non-elite sports community
physically challenged
individuals with low physical mobility
volunteers
relatives
disabled
QOL
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Bevica Fonden
name: Sygekassernes Helsefond
First posted: 2020-09-03
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We will use a study design with pre- and post-measurements. The participant will be their own case-control. For optimizing the statistical strength, the individuals with low mobility will undergo two times of baseline measurements. After a minimum of a three-month trial period followup measurements will be conducted.
Primary purpose: OTHER

Brief summary: 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 by normal functioning volunteers.

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?

Detailed description: The research project consists of two sub-projects, where data collection will take place independently of each other. For both projects, we will use a self-controlled study design with pre- and post-measurements of the participant. Through a mixed-method design combining both quantitative and qualitative data will be obtained from the following three target groups:

1. Individuals with low physical mobility (referred to as 'Handiathletes' in the TT-subproject and 'Passengers' in the CUA-sub project)
2. Volunteers (Runners and Pilots)
3. Relatives (to the Handiathletes) and employees at nursing homes (older people)

I collaboration with the two initiatives: the Team Twin- \& Cycling without Age-foundation, the study intend to recruit approximately 25 'Handiathletes' and 25 'Passengers' with low physical mobility and a non-defined number of volunteer-runners, pilots and relatives from most recent established local departments of TT and nursing homes who offers the CUA-concepts to the nursing home residents. Prior to the enrollment, all participants will be given oral and written participant information and give their written consent to participate. Depending on the target group, each group will undergo different data collection methods (described under outcome).

Team Twin description:

Primo 2021, the Handiathletes (TT) who meet eligibility criteria will undergo two clinical pre-test days within a two weeks interval. Starting from approximately ultimo February, a training period of minimum 3 months will start. All the participant target groups train and participate in prescheduled races in their respective departments of TT. During the 3 months of training, data will be collected from the different target groups (see outcome measure). After the 3 months of training, the 'Handiathletes' will undergo one clinical post-test.

The Cycling Without Age description:

Primo 2021, the Pilots (CUA) who meet eligibility criteria will be enrolled in the project - a trial period of minimum 3 months. We will conduct pre- and post measures regarding the research questions (described under outcome)

Eligibility criteria: Inclusion Criteria:

Disabled from the departments of TT:

- Pass the medical examination conducted by the responsible investigator at the laboratory.

Volunteers;

* Active member of a local department of TT
* Volunteer in Cycling without Age

Relatives and nursing home employees;

* Relative to the enrolled disabled participant
* working at a nursing home who offers CUA

Exclusion Criteria:

- Sustain damage, which makes the person unable to continue the training sessions.

Primary outcomes:
measure: Quality Of Life (QOL)
timeFrame: Baseline to follow-up
Secondary outcomes:
measure: Physiological Health
timeFrame: Baseline to follow-up
measure: Mental Health
timeFrame: Baseline to follow-up
measure: Social Health
timeFrame: Baseline to follow-up
measure: Autonomy
timeFrame: Baseline to follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National institute of Public Health
Study officials:
affiliation: National Institute of Public Health, SDU
name: Christina B Petersen, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Public Health, SDU
name: Mette Toftager, Researcher
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jorgensen A, Petersen CB, Eghoj M, Toftager M. When Movement Moves: Study Protocol for a Multi-Method Pre/Post Evaluation Study of Two Programmes; the Danish Team Twin and Cycling Without Age. Int J Environ Res Public Health. 2021 Sep 23;18(19):10008. doi: 10.3390/ijerph181910008.