AgingNCT06386536
Development and Evaluation of TRIVEL Smart Bike Training Prescription Programs.
A study testing Intelligent stationary bike and Conventional stationary bilke in people with Aging and Mobility Limitation, run by Sylvie Nadeau at 1 site in Canada.
Trial summary
This pilot A-B study aims to develop and validate personalized training programs for older adults with decreased mobility on a Semi-Reclining Intelligent Stationary Bike prototype. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Aging, Mobility Limitation
- What is being tested?
- Intelligent stationary bike and Conventional stationary bilke
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2024to May 2024
- 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being aged 50 and over
- Having impaired standing mobility associated with aging and/or a stable chronic illness (> 6 months; controlled health condition, no change in medication, routine medical follow-up ; no emergency consultation episode).
- Being able to walk without human assistance for short distances
- Being able to tolerate 90 minutes of activities with rest.
- Being able able to come to the research center for 13 visits, twice a week.
Who cannot join
- Individuals with or at high risk of having a heart or lung condition (thoracic surgery, angina, myocardial infarction, uncontrolled high blood pressure, shortness of breath at rest).
- Being unable to pedal on a seated stationary bike.
- Having active treatments, including physiotherapy and occupational therapy.
- Having moderate and severe cognitive problems (Mini-Mental State Examination (MMSE) score≤ 21/30).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
L'Institut de réadaptation Gingras-Lindsay-de-Montréal
Montreal, Quebec, H3S 2J4
Sylvie Nadeau, PhD, 5143436111 ext. 12253, sylvie.nadeau@umontreal.ca
Roua Walha, PhD, 8199195095, roua.walha@umontreal.ca
About this study
Official title: Cycling for Improved Health: Development and Evaluation of TRIVEL's Smart Bike Training Prescription Programs
This pilot A-B study aims to develop and validate personalized training programs for older adults with decreased mobility on a Semi-Reclining Intelligent Stationary Bike prototype.
The study also aims to assess the feasibility and acceptability of the training programs and to document their preliminary effects on physical health, perceived well-being, and quality of life. Ten participants will take part in five personalized training sessions with the intelligent bike and five standard training sessions with a traditional stationary bike.
Read the detailed description
An intelligent stationary bike prototype (iBike) is being developed to evaluate the lower limbs' function during pedaling. The iBike uses artificial intelligence to prescribe personalized training programs based on individual pedaling data. This pilot study aims to develop the training programs, validate their prescription by the iBike, and assess their feasibility, acceptability, and preliminary effects on physical health, perceived well-being, and quality of life in older adults with decreased mobility.
First, the iBike training modules will be developed through a thorough literature review, and prescription criteria will be identified based on the users' pedaling and clinical data as well as expert opinion. Second, 10 participants' lower limb function (i.e. strength, range of motion, coordination and endurance) will be evaluated by the iBike during active and passive pedaling. The evaluation results will be used by the iBike to prescribe a personalized training program. Expert clinicians will also be provided with the ibike evaluation data and will be asked to recommend a personalized exercise program for each participant based on their data. The iBike's prescription of training programs will be validated by comparing it with that of expert clinicians. Third, the feasibility, acceptability, and preliminary effects of the iBike training programs on mobility, physical health, perceived well-being, and quality of life will be assessed through ten training sessions (twice weekly for 45 minutes) with ten older adults using an A-B study design. During the A and B phases, participants will undergo training with either the iBike or a conventional stationary bike.
Ultimately, the goal is to deploy and test this technology in various living spaces and rehabilitation environments to demonstrate its benefits on the physical activity level of healthy older adults and those with mobility problems.
- Conditions
- Aging, Mobility Limitation
- Being tested
- Intelligent stationary bike, Conventional stationary bilke
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent stationary bikeDevice
A stationary motorized bike prototype that can evaluate lower limb functions such as strength, coordination, range of motion, and tonus. Based on the evaluation results, the iBike proposes a training program that is specific to each individual needs. Moreover, the intelligent bike offers diverse pedaling modes such as forward and backward pedaling, assisted pedaling, isotonic pedaling and pedaling with sensory stimulations.
Conventional stationary bilkeDevice
A conventional stationary bike that can be found in gyms or rehab centers.
| Study group | Role | What they receive |
|---|---|---|
| Experimental AB group | Experimental | In this arm, 5 participants will train on the intelligent bike for 5 sessions followed by 5 sessions on a conventional bike (5 participants). Receives: Device: Intelligent stationary bike; Device: Conventional stationary bilke |
| Active comparator BA group | Active comparator | The participants in this arm will start training on a conventional bike for 5 sessions followed by 5 sessions on the intelligent bike (5 participants). Receives: Device: Intelligent stationary bike; Device: Conventional stationary bilke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking ability and functional capacity
2min walk test (2MWT): the participants will be asked to walk as fast as they can, safely, without assistance for two minutes. This outcome will be measured 3 times at baseline and once at the end of each phase of the trial.
Measured: 8 to 10 weeks
Leg strength and endurance
The sit to stand test: evaluated as the number of stands a person can complete in 30 seconds. This outcome will be measured 3 times at baseline and once at the end of each phase of the trial.
Measured: 8-9 weeks
Secondary outcomes (2)
Well-being
Well being will be assessed with the World Health Organization Well being Index (WHO-5). This outcome will be measured at baseline and at the end of each phase of the trial. The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible perception of well being.
Measured: 8-9 weeks
Quality of life
Quality of life will be assessed with the EuroQol Group 5-Dimensions Health Status Questionnaire (EQ5D). This outcome will be measured at baseline and at the end of each phase of the trial.The raw score ranges from 1 to 25, 1 representing best possible and 25 representing worst possible quality of life.
Measured: 8-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start15 Jan 2024
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A single-subject reversal study design (A-B) will be used. During the A and B phases, the participants will undergo training with either the VI-TRIVEL or a conventional stationary bike.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sylvie Nadeau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sylvie Nadeau, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Investigators
- Sylvie Nadeau, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386536
- Sponsor's protocol ID
- 2023-1796
- Status last verified
- Apr 2024
- First submitted
- 23 Feb 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycling for Improved Health: Development and Evaluation of TRIVEL's Smart Bike Training Prescription Programs
- ClinicalTrials.gov ID
- NCT06386536
- Acronym / sponsor ID
- 2023-1796
- Conditions
- Aging, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sylvie NadeauUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 26 Apr 2024 (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.
This pilot A-B study aims to develop and validate personalized training programs for older adults with decreased mobility on a Semi-Reclining Intelligent Stationary Bike prototype.
The study also aims to assess the feasibility and acceptability of the training programs and to document their preliminary effects on physical health, perceived well-being, and quality of life. Ten participants will take part in five personalized training sessions with the intelligent bike and five standard training sessions with a traditional stationary bike.
Detailed description
An intelligent stationary bike prototype (iBike) is being developed to evaluate the lower limbs' function during pedaling. The iBike uses artificial intelligence to prescribe personalized training programs based on individual pedaling data. This pilot study aims to develop the training programs, validate their prescription by the iBike, and assess their feasibility, acceptability, and preliminary effects on physical health, perceived well-being, and quality of life in older adults with decreased mobility.
First, the iBike training modules will be developed through a thorough literature review, and prescription criteria will be identified based on the users' pedaling and clinical data as well as expert opinion. Second, 10 participants' lower limb function (i.e. strength, range of motion, coordination and endurance) will be evaluated by the iBike during active and passive pedaling. The evaluation results will be used by the iBike to prescribe a personalized training program. Expert clinicians will also be provided with the ibike evaluation data and will be asked to recommend a personalized exercise program for each participant based on their data. The iBike's prescription of training programs will be validated by comparing it with that of expert clinicians. Third, the feasibility, acceptability, and preliminary effects of the iBike training programs on mobility, physical health, perceived well-being, and quality of life will be assessed through ten training sessions (twice weekly for 45 minutes) with ten older adults using an A-B study design. During the A and B phases, participants will undergo training with either the iBike or a conventional stationary bike.
Ultimately, the goal is to deploy and test this technology in various living spaces and rehabilitation environments to demonstrate its benefits on the physical activity level of healthy older adults and those with mobility problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-subject reversal study design (A-B) will be used. During the A and B phases, the participants will undergo training with either the VI-TRIVEL or a conventional stationary bike.
| Arm | Type | Receives |
|---|---|---|
| Experimental AB group | Experimental | Device: Intelligent stationary bike, Device: Conventional stationary bilkeIn this arm, 5 participants will train on the intelligent bike for 5 sessions followed by 5 sessions on a conventional bike (5 participants). |
| Active comparator BA group | Active comparator | Device: Intelligent stationary bike, Device: Conventional stationary bilkeThe participants in this arm will start training on a conventional bike for 5 sessions followed by 5 sessions on the intelligent bike (5 participants). |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being aged 50 and over
- Having impaired standing mobility associated with aging and/or a stable chronic illness (> 6 months; controlled health condition, no change in medication, routine medical follow-up ; no emergency consultation episode).
- Being able to walk without human assistance for short distances
- Being able to tolerate 90 minutes of activities with rest.
- Being able able to come to the research center for 13 visits, twice a week.
Key exclusion criteria (4 listed)
- Individuals with or at high risk of having a heart or lung condition (thoracic surgery, angina, myocardial infarction, uncontrolled high blood pressure, shortness of breath at rest).
- Being unable to pedal on a seated stationary bike.
- Having active treatments, including physiotherapy and occupational therapy.
- Having moderate and severe cognitive problems (Mini-Mental State Examination (MMSE) score≤ 21/30).
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 |
|---|---|---|
| Intelligent stationary bikeA stationary motorized bike prototype that can evaluate lower limb functions such as strength, coordination, range of motion, and tonus. Based on the evaluation results, the iBike proposes a training program that is specific to each individual needs. Moreover, the intelligent bike offers diverse pedaling modes such as forward and backward pedaling, assisted pedaling, isotonic pedaling and pedaling with sensory stimulations. | Device | Active comparator BA group, Experimental AB group |
| Conventional stationary bilkeA conventional stationary bike that can be found in gyms or rehab centers. | Device | Active comparator BA group, Experimental AB group |
Primary outcome
Walking ability and functional capacity
Time frame: 8 to 10 weeks
2min walk test (2MWT): the participants will be asked to walk as fast as they can, safely, without assistance for two minutes. This outcome will be measured 3 times at baseline and once at the end of each phase of the trial.
Leg strength and endurance
Time frame: 8-9 weeks
The sit to stand test: evaluated as the number of stands a person can complete in 30 seconds. This outcome will be measured 3 times at baseline and once at the end of each phase of the trial.
2 secondary outcomes
Well-being
Time frame: 8-9 weeks
Quality of life
Time frame: 8-9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- 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.
Sylvie Nadeau, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent stationary bike and Conventional stationary bilke in people with Aging and Mobility Limitation, run by Sylvie Nadeau at 1 site in Canada.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Nadeau, PhD (514-343-6111 ext. 12253, sylvie.nadeau@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking ability and functional capacity (time frame: 8 to 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2024.