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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intelligent stationary bike | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 8-9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8-9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvie Nadeau, PhD | Contact | 514-343-6111 | 12253 | sylvie.nadeau@umontreal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Sylvie Nadeau, PhD | Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L'Institut de réadaptation Gingras-Lindsay-de-Montréal | Recruiting | Montreal | Quebec | H3S 2J4 | Canada |
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| Conventional stationary bilke | Device | A conventional stationary bike that can be found in gyms or rehab centers. |
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| 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. |
| 8-9 weeks |