Aged; Disable; Exercise; Rehabilitation; WheelchairNCT05487898
Benefits of Cycling Wheelchair Training for Elderly With Physical Disability
A study testing Cycling wheelchair in people with Aged; Disable; Exercise; Rehabilitation; Wheelchair, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
To investigate the feasibility of cycling wheelchair training as an exercise for elderly disabled patients, and to determine its effects on cognition, quality of life, aerobic capacity and physiological markers. We measure SF-12. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged; Disable; Exercise; Rehabilitation; Wheelchair
- What is being tested?
- Cycling wheelchair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2021to 31 Dec 2021
- 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age >65 years old
- with a functional ambulation category scale (FAC) level 4 or below
- muscle strength of both lower limbs was >3 as the , or the muscle strength of one lower limb was 4 or above, as rated by the Medical Research Council Scale (MRC).
Who cannot join
- hospitalized for acute medical problems within the past 3 months
- having cardiopulmonary disease that could cause exercise hazards
- unable to perform repetitive pedaling exercise due to diseases of the lower limbs
- with pressure ulcers around hip area
- with impaired cognitive function that did not allow completion of our questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the feasibility of cycling wheelchair training as an exercise for elderly disabled patients, and to determine its effects on cognition, quality of life, aerobic capacity and physiological markers. We measure SF-12. Other outcome measures included the Mini-Mental State Examination, Aero bike workload test, resting blood pressure (systolic and diastolic), and heart rate.
- Being tested
- Cycling wheelchair
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling wheelchairDevice
Apply the mechanical principle of pedaling on a bicycle to a conventional wheelchair
| Study group | Role | What they receive |
|---|---|---|
| Cycyling wheelchair | Experimental | Volunteers join the cycling wheelchair training Receives: Device: Cycling wheelchair |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-12
Quality of life
Measured: one month
MMSE questionnaire
Cognitive function
Measured: one month
Cycling ergometer
Aerobic capacity
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aged; Disable; Exercise; Rehabilitation; WheelchairStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487898
- Sponsor's protocol ID
- CE22294A
- Status last verified
- Jun 2022
- First submitted
- 19 Jun 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No discuss with volunteers about sharing data to third party
Publications
Fu JC, Fu PK, Cheng YY. Benefits of Cycling Wheelchair Training for Elderly with Physical Disability: A Prospective Cohort Study. Int J Environ Res Public Health. 2022 Dec 14;19(24):16773. doi: 10.3390/ijerph192416773.
PubMed 36554652
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Cycling Wheelchair Training for Elderly With Physical Disability
- ClinicalTrials.gov ID
- NCT05487898
- Acronym / sponsor ID
- CE22294A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Aug 2022 (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.
To investigate the feasibility of cycling wheelchair training as an exercise for elderly disabled patients, and to determine its effects on cognition, quality of life, aerobic capacity and physiological markers. We measure SF-12. Other outcome measures included the Mini-Mental State Examination, Aero bike workload test, resting blood pressure (systolic and diastolic), and heart rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cycyling wheelchair | Experimental | Device: Cycling wheelchairVolunteers join the cycling wheelchair training |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age >65 years old
- with a functional ambulation category scale (FAC) level 4 or below
- muscle strength of both lower limbs was >3 as the , or the muscle strength of one lower limb was 4 or above, as rated by the Medical Research Council Scale (MRC).
Key exclusion criteria (5 listed)
- hospitalized for acute medical problems within the past 3 months
- having cardiopulmonary disease that could cause exercise hazards
- unable to perform repetitive pedaling exercise due to diseases of the lower limbs
- with pressure ulcers around hip area
- with impaired cognitive function that did not allow completion of our questionnaires.
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 |
|---|---|---|
| Cycling wheelchairApply the mechanical principle of pedaling on a bicycle to a conventional wheelchair | Device | Cycyling wheelchair |
Primary outcome
SF-12
Time frame: one month
Quality of life
MMSE questionnaire
Time frame: one month
Cognitive function
Cycling ergometer
Time frame: one month
Aerobic capacity
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 4 Aug 2022.
- Derived from this study: PubMed 36554652Fu JC, Fu PK, Cheng YY. Benefits of Cycling Wheelchair Training for Elderly with Physical Disability: A Prospective Cohort Study. Int J Environ Res Public Health. 2022 Dec 14;19(24):16773. doi: 10.3390/ijerph192416773.
- Individual participant dataSharing planned: No. No discuss with volunteers about sharing data to third party
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling wheelchair in people with Aged; Disable; Exercise; Rehabilitation; Wheelchair, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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 4 Aug 2022. 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 Taiwan. 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?
SF-12 (time frame: one month). The study lists 3 primary outcomes in all. 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 NCT05487898, which also lists 1 linked publication.
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 4 Aug 2022.