Development and Evaluation of TRIVEL Smart Bike Training Prescription Programs.

Aging Clinical Trial

Official title:

Cycling for Improved Health: Development and Evaluation of TRIVEL's Smart Bike Training Prescription Programs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386536
• Other study ID #: 2023-1796
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
• Contact: Sylvie Nadeau, PhD
• Phone: 514-343-6111
• Email: sylvie.nadeau[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aging
• Mobility Limitation

Intervention

Device:
• Intelligent stationary bike
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 bilke
A conventional stationary bike that can be found in gyms or rehab centers.

Locations

Country	Name	City	State
Canada	L'Institut de réadaptation Gingras-Lindsay-de-Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sylvie Nadeau

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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