- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06546891
Using an Adaptive Rower for People Using Motorized Wheelchairs
Using an Adaptive Rower for People Using Motorized Wheelchairs to Improve Cardiovascular Fitness
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:
- What is the impact on participant's cardiovascular endurance, and perception of mobility and quality of life?
- 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,
Study Overview
Status
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Carolina
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Columbia, South Carolina, United States, 29208
- Public Health Research Center
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West Columbia, South Carolina, United States, 29169
- Still Hopes Retirement Community
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Use a motorized wheelchair for mobility
- Able to perform a rowing motion with upper extremities with or without grip aids
Exclusion Criteria:
- Existing pressure sores
- Increasing pain with rowing motion
- Unstable angina
- Uncontrolled arrythmia
- Acute illness with fever
- Blood pressure above 180/100 mmHg
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Single Group Intervention Arm - Adaptive Rowing
12 supervised and coached sessions of 10-20 minutes of moderate to vigorous exercise using an adaptive rower.
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12 supervised and coached sessions of 10-20 minutes of moderate to vigorous exercise using an adaptive rower.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Six Minute Arm Test
Time Frame: Study Start (Week 1) and at Study Completion (week 7-8)
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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
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Study Start (Week 1) and at Study Completion (week 7-8)
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Spinal Cord Injury Functional Inventory basic mobility, motorized wheelchair mobility and resilience subscales
Time Frame: Study Start (Week 1) and at Study Completion (week 7-8)
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Scores from 0-100% where mean scores for population is 50%, higher score better outcome
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Study Start (Week 1) and at Study Completion (week 7-8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability Scale
Time Frame: Study Completion (week 7-8)
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a standardized 10-question survey for perception of usability, scored from 0-100%, higher score, better outcome
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Study Completion (week 7-8)
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Physical Activity Enjoyment Scale-Short (PACES-S)
Time Frame: Study Completion (week 7-8)
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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
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Study Completion (week 7-8)
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Heart Rate (beats per minute), mean and range at rest, mean and range during rowing
Time Frame: 2 x a week through study completion, 7-8 weeks
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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
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2 x a week through study completion, 7-8 weeks
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Rate of Perceived Exertion (RPE)-Borg 6-20 Scale
Time Frame: 2 x a week through study completion, 7-8 weeks
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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
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2 x a week through study completion, 7-8 weeks
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Pain Scale (0-10 visual analog scale) and body location of pain verbalized by participant and recorded by study personnel
Time Frame: 2 x a week through study completion, 7-8 weeks
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participant complaints of discomfort or pain verbally stated along with location.
Higher means worse pain, lower is better outcome
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2 x a week through study completion, 7-8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Self-Efficacy for Exercise Scale
Time Frame: Study Start (Week 1) and at Study Completion (week 7-8)
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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 .
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Study Start (Week 1) and at Study Completion (week 7-8)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00137469
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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