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Completed

NCT Number: NCT04536779

"When Movement Moves" - The Health Benefits Among Individuals With Low Physical Mobility Moved by 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 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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National institute of Public Health

Copenhagen, 1455, Denmark

About this study

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:

  • Individuals with low physical mobility (referred to as 'Handiathletes' in the TT-subproject and 'Passengers' in the CUA-sub project)
  • Volunteers (Runners and Pilots)
  • 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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training in the local departments of TT and cycling trips with CUA

Other

in a minimum of 3 months, the individuals with low physical mobility will conduct a minimum of 8-10 training and cycling sessions.

Primary outcomes

  1. Quality Of Life (QOL)

    Time frame: Baseline to follow-up

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

Secondary outcomes

  1. Physiological Health

    Time frame: Baseline to follow-up

    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
  2. Mental Health

    Time frame: Baseline to follow-up

    Measured by self-reported questionnaire and interviews:

    • wellbeing and life satisfaction
    • loneliness
    • Acceptance and coping (learn to live with diagnosis)
  3. Social Health

    Time frame: Baseline to follow-up

    Measured by interviews and self-reported questionnaire:

    • Network, relations and Sense of Coherence (SOC)
    • Acceptance from surroundings
  4. Autonomy

    Time frame: Baseline to follow-up

    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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Bevica Fonden
  • Rigshospitalet, Denmark
  • Sygekassernes Helsefond

Registry information

Official study 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

Acronym: WMM

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 3, 2020
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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