Clinical trial NCT03941600: Feasibility of Exercise and Spinal Cord Injury
Official title: Feasibility of a Community-based Exercise Intervention for Persons With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: occupational therapy
exercise
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-05-08
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)
timeFrame: Baseline and Up to 4 weeks post intervention
measure: DEXA - Body Composition Overall Body Fat % Change
timeFrame: Baseline and Up to 4 weeks post intervention
measure: Metabolic Blood Chemistries - HbA1c Level Change
timeFrame: Baseline and Up to 4 weeks post intervention
measure: Metabolic Blood Chemistries - Cholesterol Change
timeFrame: Baseline and Up to 4 weeks post interventions
Secondary outcomes:
measure: Upper Extremity Strength - Upper Body Strength Change
timeFrame: Baseline and Up to 4 weeks post intervention
measure: PROMIS - Fatigue Short Form 8a
timeFrame: Baseline and Up to 4 weeks post intervention
measure: PROMIS - Emotional Distress - Depression - Short Form 8a
timeFrame: Baseline and Up to 4 weeks post intervention
measure: PROMIS - Pain Intensity - Short Form 3a
timeFrame: Baseline and Up to 4 weeks post intervention
measure: PROMIS - Pain Interference - Short Form 8a
timeFrame: Baseline and Up to 4 weeks post intervention
measure: PROMIS - Sleep Disturbance - Short Form 8a
timeFrame: Baseline and Up to 4 weeks post intervention
measure: PROMIS - Emotional Support
timeFrame: Baseline and Up to 4 weeks post intervention
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Kerri A Morgan, PhD
role: PRINCIPAL_INVESTIGATOR
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