Physical DisabilityWMMNCT04536779
"When Movement Moves" - The Health Benefits Among Individuals With Low Physical Mobility Moved by Others
A study testing Training in the local departments of TT and cycling trips with CUA in people with Physical Disability and Healthy, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Disability, Healthy
- What is being tested?
- Training in the local departments of TT and cycling trips with CUA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Sustain damage, which makes the person unable to continue the training sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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:
- Does movement by others improves the quality of life (QOL) among individuals with low physical mobility
- Does movement by others improves the physiological health among individuals with low physical mobility
- Does moving individuals with low physical mobility improve health among normal functioning individuals (i.e volunteer runners and pilots)?
- 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?
Read the 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:
- 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)
- Conditions
- Physical Disability, Healthy
- Being tested
- Training in the local departments of TT and cycling trips with CUA
- Keywords
- non-elite sports community, physically challenged, individuals with low physical mobility, volunteers, relatives, disabled, QOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in the local departments of TT and cycling trips with CUAOther
in a minimum of 3 months, the individuals with low physical mobility will conduct a minimum of 8-10 training and cycling sessions.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with low mobility (Disabled and Elder) | Experimental | minimum 8-10 training sessions in at least three months. Receives: Other: Training in the local departments of TT and cycling trips with CUA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Of Life (QOL)
Validated self-reported measure of quality of life (i.e. Cantril Ladder)
Measured: Baseline to follow-up
Secondary outcomes (4)
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
Measured: 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)
Measured: Baseline to follow-up
Social Health
Measured by interviews and self-reported questionnaire:
- Network, relations and Sense of Coherence (SOC)
- Acceptance from surroundings
Measured: 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
Measured: Baseline to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Feb 2021
- Primary completion1 Dec 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Bevica Fonden, Sygekassernes Helsefond
- Responsible party
- Principal investigator, Christina Bjørk Petersen, University of Southern Denmark
- Investigators
- Christina B Petersen, Assoc. Prof, Principal investigator, National Institute of Public Health, SDUMette Toftager, Researcher, Principal investigator, National Institute of Public Health, SDU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536779
- Sponsor's protocol ID
- 19/66334
- Acronym
- WMM
- Status last verified
- Apr 2023
- First submitted
- 28 Aug 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34639309Jorgensen 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.
PubMed 37941848
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04536779
- Acronym / sponsor ID
- WMM / 19/66334
- Conditions
- Physical Disability, Healthy
- Keywords
- non-elite sports community, physically challenged, individuals with low physical mobility, volunteers, relatives, disabled, QOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Bevica Fonden, Sygekassernes Helsefond
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does movement by others improves the quality of life (QOL) among individuals with low physical mobility
- Does movement by others improves the physiological health among individuals with low physical mobility
- Does moving individuals with low physical mobility improve health among normal functioning individuals (i.e volunteer runners and pilots)?
- 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:
- 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)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individuals with low mobility (Disabled and Elder) | Experimental | Other: Training in the local departments of TT and cycling trips with CUAminimum 8-10 training sessions in at least three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (1 listed)
- Sustain damage, which makes the person unable to continue the training sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in the local departments of TT and cycling trips with CUAin a minimum of 3 months, the individuals with low physical mobility will conduct a minimum of 8-10 training and cycling sessions. | Other | Individuals with low mobility (Disabled and Elder) |
Primary outcome
Quality Of Life (QOL)
Time frame: Baseline to follow-up
Validated self-reported measure of quality of life (i.e. Cantril Ladder)
4 secondary outcomes
Physiological Health
Time frame: Baseline to follow-up
Mental Health
Time frame: Baseline to follow-up
Social Health
Time frame: Baseline to follow-up
Autonomy
Time frame: Baseline to follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 34639309Jorgensen 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.
- Derived from this study: PubMed 37941848Jorgensen 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.
- The Team Twin FoundationLink provided by the sponsor.
- Cycling Without AgeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina B Petersen, Assoc. Prof principal investigator
National Institute of Public Health, SDU
Mette Toftager, Researcher principal investigator
National Institute of Public Health, SDU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in the local departments of TT and cycling trips with CUA in people with Physical Disability and Healthy, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality Of Life (QOL) (time frame: Baseline to follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04536779, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.