Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650410
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Virtual Intervention for Vertebral frActure a Pilot Feasibility Study for a Multicentre Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Virtual Intervention for Vertebral frActure a Pilot Feasibility Study for a Multicentre Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIVA
Brief Summary:
Spine fractures are the most common fracture due to osteoporosis They happen during falls or activities of daily life like bending to tie shoes Fractures of the spine can result in pain which can sometimes last for a long time Spine fractures can affect breathing appetite digestion and mobility and can restrict or modify peoples work or daily activities There are no standard rehabilitation programs after spine fracture and patients often have to pay for rehabilitation Rehabilitation can be hard to access especially in rural or remote locations It can be hard to find health care or rehabilitation providers who specialize in treating spine fractures After reviewing research and consulting patients and health care providers to understand their experiences with spine fracture rehabilitation the research team developed a toolkit for a virtual rehabilitation program for people with spine fractures called VIVA
The research team wants to submit a grant for a clinical trial to implement VIVA in five provinces and determine if VIVA reduces pain and improves physical functioning and quality of life and if the benefits outweigh the costs Before this the team proposes to do a pilot study to test how feasible it is to do a study of VIVA in three provinces
The research team wants to submit a grant for a clinical trial to implement VIVA in five provinces and determine if VIVA reduces pain and improves physical functioning and quality of life and if the benefits outweigh the costs Before this the team proposes to do a pilot study to test how feasible it is to do a study of VIVA in three provinces
Detailed Description:
A multicenter trial will be conducted to investigate the feasibility of a future trial of VIVA in adults with spine fractures in Ontario British Columbia and Quebec As secondary outcomes the research team will explore the effect of the intervention on physical function and balance pain fear of movement falls falls self-efficacy quality of life mood nutrition risk and physical activity Adults over the age of 50 who have had at least one spine fracture in the past two years due to osteoporosis will be recruited Participants will be randomized either to the immediate receipt of VIVA intervention or delayed receipt of VIVA 10 weeks post-randomization The VIVA intervention involves once weekly 11 rehabilitation sessions delivered by an exercise professional for eight weeks The study will take place at the GERAS Centre Ontario Unity Health Ontario University of British Columbia British Columbia and McGill University Health Centre Quebec University of Waterloo will be the coordinating centre The findings of this study will be used to decide if a larger clinical trial is feasible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None