Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546891
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Using an Adaptive Rower for People Using Motorized Wheelchairs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Using an Adaptive Rower for People Using Motorized Wheelchairs to Improve Cardiovascular Fitness
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The goal of this clinical trial are to determine the feasibility and impact of an adaptive rower exercise intervention for adults who use motorized wheelchairs for mobility
The main questions it aims to answer are
1 What is the impact on participants cardiovascular endurance and perception of mobility and quality of life
2 Is the intervention feasible acceptable and safe
examine feasibility of the adaptive rower intervention through measures of acceptability adherence intensity and safety for adults who use motorized wheelchairs for mobility
Participants will complete 12 sessions of 10-20 minutes of supervised and coached moderate to vigorous activity using the adaptive rower over a seven week period Participants will complete pre- and post- outcome assessments of cardiovascular fitness and outcome surveys
The main questions it aims to answer are
1 What is the impact on participants cardiovascular endurance and perception of mobility and quality of life
2 Is the intervention feasible acceptable and safe
examine feasibility of the adaptive rower intervention through measures of acceptability adherence intensity and safety for adults who use motorized wheelchairs for mobility
Participants will complete 12 sessions of 10-20 minutes of supervised and coached moderate to vigorous activity using the adaptive rower over a seven week period Participants will complete pre- and post- outcome assessments of cardiovascular fitness and outcome surveys
Detailed Description:
A rolling prospective clinical trial with a target population of 10 participants in the Columbia South Carolina area will evaluate the impact of the adaptive rower on cardiovascular fitness participant perception and feasibility for people who use motorized wheelchairs
Participants will be screened for inclusionexclusion criteria perform initial outcome measures and instructions on rowing in the first visit and then have 12 exercise sessions over 6 or 7 weeks followed by a final visit for final outcome measures All research will occur at the University of South Carolina Rehab Lab in the public health research center building
Over the 6-7 week intervention period participants will exercise approximately two times per week with two additional visits available in week 7 for any missed sessions to fulfill the 12-visit dosage Session data will include measures of heart rate 0-10 Borg rate of perceived exertion RPE and power output rower output in watts The session goal is to maintain moderate-vigorous intensities 5-8 on the Borg RPE scale with individually modifiable intervals of work and rest with the goal of 10-20 minutes of moderate-vigorous physical activity total per session depending on the individuals initial fitness levels as judged by self-reported activity level and performance on the initial six-minute arm test and progressed as able After completing the intervention period participants will return for final evaluation
Participants will be screened for inclusionexclusion criteria perform initial outcome measures and instructions on rowing in the first visit and then have 12 exercise sessions over 6 or 7 weeks followed by a final visit for final outcome measures All research will occur at the University of South Carolina Rehab Lab in the public health research center building
Over the 6-7 week intervention period participants will exercise approximately two times per week with two additional visits available in week 7 for any missed sessions to fulfill the 12-visit dosage Session data will include measures of heart rate 0-10 Borg rate of perceived exertion RPE and power output rower output in watts The session goal is to maintain moderate-vigorous intensities 5-8 on the Borg RPE scale with individually modifiable intervals of work and rest with the goal of 10-20 minutes of moderate-vigorous physical activity total per session depending on the individuals initial fitness levels as judged by self-reported activity level and performance on the initial six-minute arm test and progressed as able After completing the intervention period participants will return for final evaluation
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