Development and Evaluation of TRIVEL Smart Bike Training Prescription Programs.

Sylvie Nadeau

Status: Enrolling

Conditions: Aging; Mobility Limitation

Treatments: Device: Conventional stationary bilke; Device: Intelligent stationary bike

Study type: Interventional

Funder types: Other

Identifiers

NCT06386536

2023-1796

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 50 to 95 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Experimental AB group

Experimental group

Description:

In this arm, 5 participants will train on the intelligent bike for 5 sessions followed by 5 sessions on a conventional bike (5 participants).

Treatment:

Device: Conventional stationary bilke

Device: Intelligent stationary bike

Active comparator BA group

Active Comparator group

Description:

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).

Treatment:

Device: Conventional stationary bilke

Device: Intelligent stationary bike