Feasibility of Exercise and Spinal Cord Injury

The Washington University

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Behavioral: Community-based Exercise Intervention group (CBE); Behavioral: Exercise Education Control group (EEG)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03941600

201809174

K12HD055931 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

49 participants in 2 patient groups, including a placebo group

Community-based Exercise Intervention group (CBEI)

Active Comparator group

Description:

A group performing a 12-week guided exercise program at an accessible community health and wellness center

Treatment:

Behavioral: Community-based Exercise Intervention group (CBE)

Exercise Education Control group (EEG)

Placebo Comparator group

Description:

A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.

Treatment:

Behavioral: Exercise Education Control group (EEG)