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| Name | Class |
|---|---|
| Foundation for Physical Therapy, Inc. | INDUSTRY |
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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 question[s] it aims to answer are:
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,
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 inclusion/exclusion 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 individual's 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group Intervention Arm - Adaptive Rowing | Experimental | 12 supervised and coached sessions of 10-20 minutes of moderate to vigorous exercise using an adaptive rower. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Rowing | Behavioral | 12 supervised and coached sessions of 10-20 minutes of moderate to vigorous exercise using an adaptive rower. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Six Minute Arm Test | Submaximal fitness test using an upper body ergometer. Maximum power, maximum rate of perceived exertion and maximum heart rate are recorded. Higher power, lower RPE and lower maximum heart rate is better outcome | Study Start (Week 1) and at Study Completion (week 7-8) |
| Spinal Cord Injury Functional Inventory basic mobility, motorized wheelchair mobility and resilience subscales | Scores from 0-100% where mean scores for population is 50%, higher score better outcome | Study Start (Week 1) and at Study Completion (week 7-8) |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Scale | a standardized 10-question survey for perception of usability, scored from 0-100%, higher score, better outcome | Study Completion (week 7-8) |
| Physical Activity Enjoyment Scale-Short (PACES-S) |
| Measure | Description | Time Frame |
|---|---|---|
| Short Self-Efficacy for Exercise Scale | A standardized 9-question survey to measure participant confidence in being able to exercise under a variety of conditions. Scores are 0-90 where higher scores indicate better outcome . | Study Start (Week 1) and at Study Completion (week 7-8) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Research Center | Columbia | South Carolina | 29208 | United States | ||
| Still Hopes Retirement Community |
De-identified data will be part of dissemination of project results and be shared on open science framework. Data shared would be basic demographics (age, sex), pre and post outcome measures (six minute arm test time, spinal cord functional index score, PROMIS Scales for wheelchair mobility and resilience), session data (minutes of rowing, minutes of rest time, RPE ratings, heart rate data, pain/soreness ratings)
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Data will be available after completion of the study when dissemination occurs; and will be available indefinitely
website
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2024 | Aug 6, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Single Group Case Series
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a standardized 4-question survey for perception of enjoyment of a physical activity intervention, scale is 1 (strongly disagree) to 5 (strongly agree), total score 4-20 with higher score as better outcome
| Study Completion (week 7-8) |
| Heart Rate (beats per minute), mean and range at rest, mean and range during rowing | Heart rate will be recorded at rest and throughout the exercise intervention using a polar heart rate monitor and actigraph. Heart rate near target zone, better outcome | 2 x a week through study completion, 7-8 weeks |
| Rate of Perceived Exertion (RPE)-Borg 6-20 Scale | RPE will be verbally stated by participant and recorded by study personnel at beginning, mid and end of steady state portion, and at each interval for interval exercise. (RPE, 6-20, higher means higher intensity) RPE within target zone of moderate intensity (12-14) better outcome | 2 x a week through study completion, 7-8 weeks |
| Pain Scale (0-10 visual analog scale) and body location of pain verbalized by participant and recorded by study personnel | participant complaints of discomfort or pain verbally stated along with location. Higher means worse pain, lower is better outcome | 2 x a week through study completion, 7-8 weeks |
| West Columbia |
| South Carolina |
| 29169 |
| United States |