Recruiting

TRIVEL Smart Bike

Sponsor:

Sylvie Nadeau

Code:

NCT06386536

Conditions

Aging

Mobility Limitation

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Intelligent stationary bike

Conventional stationary bilke

Study Details

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.

Conditions

Aging

Mobility Limitation

Study ID

NCT06386536

Start date

Jan 15, 2024

Status verified date

Apr, 2024

Completion date

May, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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).

Interventions

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.

Primary outcome measure

  • Walking ability and functional capacity [ Time Frame: 8 to 10 weeks ]
  • Leg strength and endurance [ Time Frame: 8-9 weeks ]

Central Contacts and Locations

Central contacts

Sylvie Nadeau, PhD

514-343-6111sylvie.nadeau@umontreal.ca

Locations

L'Institut de réadaptation Gingras-Lindsay-de-Montréal

Recruiting

Montréal, Quebec, Canada, H3S 2J4

Contacts

Sylvie Nadeau, PhD

5143436111sylvie.nadeau@umontreal.ca

Roua Walha, PhD

8199195095roua.walha@umontreal.ca

Principal Investigator:

Sylvie Nadeau, PhD

More Information

Sponsor

Sylvie Nadeau

Last update posted

Apr 26, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sylvie Nadeau on 2024-04-26.