Clinical trial NCT06386536: Development and Evaluation of TRIVEL Smart Bike Training Prescription Programs.
Official title: Cycling for Improved Health: Development and Evaluation of TRIVEL's Smart Bike Training Prescription Programs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Mobility Limitation
Lead sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Walking ability and functional capacity
timeFrame: 8 to 10 weeks
measure: Leg strength and endurance
timeFrame: 8-9 weeks
Secondary outcomes:
measure: Well-being
timeFrame: 8-9 weeks
measure: Quality of life
timeFrame: 8-9 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: L'Institut de réadaptation Gingras-Lindsay-de-Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Sylvie Nadeau, PhD
role: PRINCIPAL_INVESTIGATOR
References: