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Clinical Trials/NCT04536779
NCT04536779
Completed
N/A

"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

University of Southern Denmark1 site in 1 country76 target enrollmentFebruary 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Physical Disability
Sponsor
University of Southern Denmark
Enrollment
76
Locations
1
Primary Endpoint
Quality Of Life (QOL)
Status
Completed
Last Updated
3 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
February 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christina Bjørk Petersen

Associate Professor

University of Southern Denmark

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.

Outcomes

Primary Outcomes

Quality Of Life (QOL)

Time Frame: Baseline to follow-up

Validated self-reported measure of quality of life (i.e. Cantril Ladder)

Secondary Outcomes

  • Autonomy(Baseline to follow-up)
  • Social Health(Baseline to follow-up)
  • Physiological Health(Baseline to follow-up)
  • Mental Health(Baseline to follow-up)

Study Sites (1)

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