Clinical trial NCT06546891: Using an Adaptive Rower for People Using Motorized Wheelchairs
Official title: Using an Adaptive Rower for People Using Motorized Wheelchairs to Improve Cardiovascular Fitness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: People Who Use Motorized Wheelchairs for Mobility
Keywords: motorized wheelchair
exercise
adaptive fitness
rowing
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy, Inc.
First posted: 2024-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Case Series
Primary purpose: TREATMENT

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 question\[s\] it aims to answer are:

1. What is the impact on participant's 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Six Minute Arm Test
timeFrame: Study Start (Week 1) and at Study Completion (week 7-8)
measure: Spinal Cord Injury Functional Inventory basic mobility, motorized wheelchair mobility and resilience subscales
timeFrame: Study Start (Week 1) and at Study Completion (week 7-8)
Secondary outcomes:
measure: System Usability Scale
timeFrame: Study Completion (week 7-8)
measure: Physical Activity Enjoyment Scale-Short (PACES-S)
timeFrame: Study Completion (week 7-8)
measure: Heart Rate (beats per minute), mean and range at rest, mean and range during rowing
timeFrame: 2 x a week through study completion, 7-8 weeks
measure: Rate of Perceived Exertion (RPE)-Borg 6-20 Scale
timeFrame: 2 x a week through study completion, 7-8 weeks
measure: Pain Scale (0-10 visual analog scale) and body location of pain verbalized by participant and recorded by study personnel
timeFrame: 2 x a week through study completion, 7-8 weeks
Other outcomes:
measure: Short Self-Efficacy for Exercise Scale
timeFrame: Study Start (Week 1) and at Study Completion (week 7-8)
Locations:
city: Columbia
country: United States
facility: Public Health Research Center
state: South Carolina
city: West Columbia
country: United States
facility: Still Hopes Retirement Community
state: South Carolina
Study officials:
References: