Feasibility of a Community-based Exercise Intervention for Persons With Spinal Cord Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- Washington University School of Medicine
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Metabolic Blood Chemistries - Cholesterol Change
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of the study is to examine the impact of a community-based exercise intervention (CBEI) for persons with spinal cord injury (PwSCI) on physiological and psychological well-being and identify barriers and facilitators to implementation.
Detailed Description
People with spinal cord injury (PwSCI) are at a greater risk for major health conditions and poorer health outcomes than the population without spinal cord injury. For PwSCI, habitual exercise is critical for both physiological and psychological well-being. Prior research indicates that exercise programs conducted in a controlled setting have positive effects on the physical and psychosocial fitness of PwSCI, but the efficacy and feasibility of these programs are not well understood in community-based settings. The proposed project aims to examine potential health benefits in response to the intervention and identify the barriers and facilitators to successful implementation of a CBEI in PwSCI. The long-term goal of this research is to improve health outcomes of PwSCI by identifying strategies to promote health and support exercise in the community. The project research aims are to: 1. Estimate improvements in physical function, cardio-metabolic health, and psychological well-being of participants enrolled in a CBEI compared to an education-only group. 2. Identify barriers, facilitators, and reasons for positive determinants for PwSCI to exercise in a community-based setting. A single-blind pilot RCT will be conducted. Forty individuals with SCI will be recruited. Each participant will be randomized into either a 12-week CBEI (n=20) or an education control group (n=20). Participants' cardiorespiratory fitness, body composition, metabolic blood chemistries and strength will be assessed pre- (T1) and post- (T2) intervention.
Investigators
Kerri Morgan
Assistant Professor of Occupational Therapy and Neurology
Washington University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of SCI
- •18 years or older
- •Have written physician approval to participate in the study
- •Ability to use upper extremities to exercise
- •Participate in \< 60 minutes of moderate-intensity exercise per week in the last month
- •Understand English at a sixth-grade level or higher
- •Be able to follow multi-step instructions
- •Independently provide informed consent
- •Willing to participate in three assessments and 36 intervention sessions
Exclusion Criteria
- •Enrollment in a structured exercise program in the past six months.
- •Have had cardiovascular complications within the past year
- •Currently receive medical treatment for an acute upper extremity injury
- •Have a Stage IV pressure injury
- •Have a cognitive impairment that does not allow them to provide consent or follow multi-step directions.
Outcomes
Primary Outcomes
Metabolic Blood Chemistries - Cholesterol Change
Time Frame: Baseline and Up to 4 weeks post interventions
Blood draws will be completed to measure cholesterol levels. Unit of measure will be in mg/dL. Participants will fast 8-10 hours prior to blood draw.
VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)
Time Frame: Baseline and Up to 4 weeks post intervention
VO2 peak will be measured using a standard computer-integrated, open-circuit, breath-by-breath metabolic measurement system (TrueOne 2400, Parvo Medics, Sandy UT) while the participant performs a graded-exercise test on an arm crank ergometer (SCIFIT PRO2, Life Fitness, Tulsa, OK). The protocol involves a 3-minute warm-up followed by a standard ramp protocol which is typically completed in 8-12 minutes.
DEXA - Body Composition Overall Body Fat % Change
Time Frame: Baseline and Up to 4 weeks post intervention
Participants will then undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety. Body fat % will be the unit of measure.
Metabolic Blood Chemistries - HbA1c Level Change
Time Frame: Baseline and Up to 4 weeks post intervention
Blood draws will be completed to measure HbA1c levels in %. Participants will fast 8-10 hours prior to blood draw.
Secondary Outcomes
- Upper Extremity Strength - Upper Body Strength Change(Baseline and Up to 4 weeks post intervention)
- PROMIS - Fatigue Short Form 8a(Baseline and Up to 4 weeks post intervention)
- PROMIS - Emotional Distress - Depression - Short Form 8a(Baseline and Up to 4 weeks post intervention)
- PROMIS - Pain Intensity - Short Form 3a(Baseline and Up to 4 weeks post intervention)
- PROMIS - Pain Interference - Short Form 8a(Baseline and Up to 4 weeks post intervention)
- PROMIS - Sleep Disturbance - Short Form 8a(Baseline and Up to 4 weeks post intervention)
- PROMIS - Emotional Support(Baseline and Up to 4 weeks post intervention)