Clinical trial NCT04007445: Exercise for People with Spinal Cord Injury
Official title: Exercise Training in a Community-based Setting for People with Spinal Cord Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
exercise
occupational therapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2019-07-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed project utilizes a mixed methods approach. An experimental strategy using a randomized control trial (single-blinded) will be used to assess the efficacy of an established transitional, community-based exercise intervention on people with SCI. Qualitative methods will be used to gather information related to optimizing implementation of a community-based exercise intervention. This project will be conducted in conjunction with Paraquad, a local independent living center. Forty participants will be randomized into an Exercise Group (EG) or Control Group (CG) by the statistician who will not be involved in either conducting outcome assessments or implementation of the intervention. This design will assist in reducing variability and maximizing the effect size for powering subsequent larger randomized control trials.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the impact of a transitional exercise intervention implemented in the community for people with SCI on psychological well-being, social factors, and physiological health.

Detailed description: People with spinal cord injuries (SCI) are at a greater risk for major health conditions and poorer health outcomes than the population without disabilities. For people with SCI, physical activity is critical for both physiological and psychological well-being. Currently a gap exists; prior research indicates that exercise programs conducted in a controlled clinical setting have positive effects on the physical and psychosocial fitness of people with SCI, but rarely are these programs available in accessible community-based exercise facilities. With this study, the investigators aim to evaluate the improvements of the exercise group - EG (formally-directed) in both psychological and physiological well-being as compared to the control group - CG (self-directed). The investigators also aim to identify the perspectives of the participants on the recruitment and enrollment process, the assessment methods, and the intervention protocol. The long-term goal of this research is to improve outcomes of people with SCI once they leave rehabilitation by identifying strategies to promote health and support exercise in the community. This study will implement rigorous research procedures to examine a transitional exercise intervention in the community for people with SCI. This study will serve as the initial step toward that goal by pilot testing an exercise intervention to help with the transition from supported exercise programs experienced during rehabilitation to the community. The investigators will recruit 40 adults with SCI to participate in this study; the EG will participate in a transitional 12-week exercise intervention at Paraquad Health and Wellness Center (PQHWC). The CG will participate in a one-hour education session, learning about the National Council on Health, Physical Activity and Disability (NCHPAD), and then they will maintain their typical physical activity on their own for a 12-week period. This project will measure the potential psychosocial and physiological health benefits of participating in a transitional community-based exercise intervention. The investigators will then use the findings to define how exercise in the community can support health outcomes and improve therapeutic interventions to promote health of people with SCI.

Eligibility criteria: Inclusion Criteria:

Participants will be non-exercising adults with SCI who have participated in less than 60 minutes of moderate-intensity exercise per week in the last month. Participants must meet the following inclusion criteria: diagnosis of an SCI; are 18 years or older; have written physician approval to participate in the study; have the ability to use upper, lower, or both sets of extremities to exercise; and have the ability to understand English.

Exclusion Criteria:

Participants will be excluded if they are medically unstable, have a cognitive impairment that does not allow them to provide consent, are currently or have previously been participants in the PQHWC or community-based exercise program, or have been enrolled in a structured exercise program over the past six months.

Primary outcomes:
measure: PROMIS - Change in Fatigue (Short Form 8a)
timeFrame: Baseline, post intervention and 3 month follow-up
measure: PROMIS - Change in Emotional Distress - Depression (Short Form 8a)
timeFrame: Baseline, post intervention and 3 month follow-up
measure: PROMIS - Change in Pain Intensity (Short Form 3a)
timeFrame: Baseline, post intervention and 3 month follow-up
measure: PROMIS - Change in Pain Interference (Short Form 8a)
timeFrame: Baseline, post intervention and 3 month follow-up
measure: PROMIS - Change in Sleep Disturbance (Short Form 8a)
timeFrame: Baseline, post intervention and 3 month follow-up
measure: PROMIS - Change in Emotional Support
timeFrame: Baseline, post intervention and 3 month follow-up
Secondary outcomes:
measure: The Exercise Self-Efficacy Scale (ESES)
timeFrame: Baseline, post intervention, 3 month follow-up
measure: RM 4-FM: Motivation for Physical Activity and Exercise/Working Out - Questionnaire
timeFrame: Baseline, post intervention, 3-month follow-up
Other outcomes:
Locations:
city: St. 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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