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

NCT ID: NCT04536779

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-02-01

Brief Summary

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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

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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)

Conditions

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Physical Disability Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Individuals with low mobility (Disabled and Elder)

minimum 8-10 training sessions in at least three months.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Bevica Fonden

OTHER

Sponsor Role collaborator

Sygekassernes Helsefond

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Christina Bjørk Petersen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christina B Petersen, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

National Institute of Public Health, SDU

Mette Toftager, Researcher

Role: PRINCIPAL_INVESTIGATOR

National Institute of Public Health, SDU

Locations

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National institute of Public Health

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 34639309 (View on PubMed)

Jorgensen A, Toftager M, Eghoj M, Ried-Larsen M, Bjork Petersen C. Heart rate responses, agreement and accuracy among persons with severe disabilities participating in the indirect movement program: Team Twin-an observational study. Front Sports Act Living. 2023 Oct 24;5:1213655. doi: 10.3389/fspor.2023.1213655. eCollection 2023.

Reference Type DERIVED
PMID: 37941848 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://teamtvilling.dk/

The Team Twin Foundation

https://cyklingudenalder.dk/

Cycling Without Age

Other Identifiers

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19/66334

Identifier Type: -

Identifier Source: org_study_id

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