"When Movement Moves" - The Health Benefits Among Individuals With Low Physical Mobility Moved by Others (WMM)

"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

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?

Study Overview

• Status: Completed
• Conditions: Healthy; Physical Disability
• Intervention / Treatment: Other: Training in the local departments of TT and cycling trips with CUA

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)

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Bjørk Petersen, Assoc. Prof; Phone Number: +4565507746; Email: chrb@sdu.dk
• Study Contact Backup: Name: Andreas Jørgensen, RA; Phone Number: +4565507718; Email: ajor@sdu.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 1455
    • National Institute of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individuals with low mobility (Disabled and Elder); minimum 8-10 training sessions in at least three months.	Other: Training in the local departments of TT and cycling trips with CUA; in a minimum of 3 months, the individuals with low physical mobility will conduct a minimum of 8-10 training and cycling sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality Of Life (QOL)	Validated self-reported measure of quality of life (i.e. Cantril Ladder)	Baseline to follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Health	Measured objectively and by self-report: Cardiorespiratory and metabolic fitness; Cognitive and physical functioning; Quantity and severity of symptoms related to their disease/disability; Sleep quality and duration	Baseline to follow-up
Mental Health	Measured by self-reported questionnaire and interviews: wellbeing and life satisfaction; loneliness; Acceptance and coping (learn to live with diagnosis)	Baseline to follow-up
Social Health	Measured by interviews and self-reported questionnaire: Network, relations and Sense of Coherence (SOC); Acceptance from surroundings	Baseline to follow-up
Autonomy	Measured by interviews and self-reported questionnaire: Independence in activities of daily living; Feeling of being in control of and taking act in one's own life; options and choices	Baseline to follow-up

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Rigshospitalet, Denmark; Sygekassernes Helsefond; Bevica Fonden
• Investigators: Principal Investigator: Christina B Petersen, Assoc. Prof, National Institute of Public Health, SDU; Principal Investigator: Mette Toftager, Researcher, National Institute of Public Health, SDU

Publications and helpful links

General Publications

• 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.

Helpful Links

• The Team Twin Foundation
• Cycling Without Age

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: volunteers; relatives; non-elite sports community; physically challenged; individuals with low physical mobility; disabled; QOL
• Other Study ID Numbers: 19/66334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No