Development and Evaluation of TRIVEL Smart Bike Training Prescription Programs.

April 23, 2024 updated by: Sylvie Nadeau

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3S 2J4
        • Recruiting
        • L'Institut de réadaptation Gingras-Lindsay-de-Montréal
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sylvie Nadeau, PhD
        • Sub-Investigator:
          • Roua Walha, PhD
        • Sub-Investigator:
          • Julie Soulard, PhD
        • Sub-Investigator:
          • Cyril Duclos, PhD
        • Sub-Investigator:
          • Nicolas Berryman, PhD
        • Sub-Investigator:
          • Elaine Deguise, PhD
        • Sub-Investigator:
          • Claudine Auger, PhD
        • Sub-Investigator:
          • Dahlia Kairy, PhD
        • Sub-Investigator:
          • David Labbé, PhD
        • Sub-Investigator:
          • Rachid Aissaoui, PhD
        • Sub-Investigator:
          • Gabriel Moisan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental AB group
In this arm, 5 participants will train on the intelligent bike for 5 sessions followed by 5 sessions on a conventional bike (5 participants).
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.
Device: Conventional stationary bilke
A conventional stationary bike that can be found in gyms or rehab centers.
Active Comparator: Active comparator BA group
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).
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.
Device: Conventional stationary bilke
A conventional stationary bike that can be found in gyms or rehab centers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 to 10 weeks
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.
8-9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Well-being
Time Frame: 8-9 weeks
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
Quality of life
Time Frame: 8-9 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sylvie Nadeau

Investigators

  • Principal Investigator: Sylvie Nadeau, PhD, Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-1796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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