Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386536
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-02-23
Brief Title:
Development and Evaluation of TRIVEL Smart Bike Training Prescription Programs
Sponsor:
Sylvie Nadeau
Organization:
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Study Overview
Official Title:
Cycling for Improved Health Development and Evaluation of TRIVELs Smart Bike Training Prescription Programs
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 ie 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 iBikes 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
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 ie 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 iBikes 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None