Development and Evaluation of TRIVEL Smart Bike Training Prescription Programs.

NCT06386536 | Recruiting

• 1 other identifier: 2023-1796
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Well-being

  8-9 weeks

• Quality of life

  8-9 weeks

Study Arms (2)

Experimental AB group

EXPERIMENTAL

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; Device: Conventional stationary bilke

Active comparator BA group

ACTIVE COMPARATOR

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; Device: Conventional stationary bilke

Interventions

Intelligent stationary bike DEVICE

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.

Active comparator BA group; Experimental AB group

Conventional stationary bilke DEVICE

A conventional stationary bike that can be found in gyms or rehab centers.

Active comparator BA group; Experimental AB group

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sylvie Nadeau: lead

Study Sites (1)

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

Montreal, Quebec, H3S 2J4, Canada

RECRUITING

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvie Nadeau, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie Nadeau, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: April 26, 2024
• Study Start: January 15, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)