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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Bevica Fonden | OTHER |
| Sygekassernes Helsefond | OTHER |
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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:
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:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with low mobility (Disabled and Elder) | Experimental | minimum 8-10 training sessions in at least three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality Of Life (QOL) | Validated self-reported measure of quality of life (i.e. Cantril Ladder) | Baseline to follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological Health | Measured objectively and by self-report:
| Baseline to follow-up |
| Mental Health |
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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;
Relatives and nursing home employees;
Exclusion Criteria:
- Sustain damage, which makes the person unable to continue the training sessions.
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| Name | Affiliation | Role |
|---|---|---|
| Christina B Petersen, Assoc. Prof | National Institute of Public Health, SDU | Principal Investigator |
| Mette Toftager, Researcher | National Institute of Public Health, SDU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National institute of Public Health | Copenhagen | 1455 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34639309 | Background | 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. | |
| 37941848 | Derived | 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. |
| Label | URL |
|---|---|
| The Team Twin Foundation | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2021 | Mar 22, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 13, 2020 | Mar 22, 2023 | ICF_001.pdf |
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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.
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Measured by self-reported questionnaire and interviews:
|
| Baseline to follow-up |
| Social Health | Measured by interviews and self-reported questionnaire:
| Baseline to follow-up |
| Autonomy | Measured by interviews and self-reported questionnaire:
| Baseline to follow-up |
| Cycling Without Age | View source |