N/A N=49 Randomized Single-blind Treatment

Feasibility of Exercise and Spinal Cord Injury

Spinal Cord Injuries

Bottom Line

View on ClinicalTrials.gov: NCT03941600 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcome: Primary: VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change) — 14.69; 14.36; 15.61; 13.74 ml/kg/min

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Community-based Exercise Intervention group (CBE) (Behavioral); Exercise Education Control group (EEG) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)	14.69; 14.36; 15.61; 13.74	—
PRIMARY DEXA - Body Composition Overall Body Fat % Change	39.800; 38.750	—
PRIMARY Metabolic Blood Chemistries - HbA1c Level Change	4.9; 5.0; 4.9; 5.0	—
PRIMARY Metabolic Blood Chemistries - Cholesterol Change	172; 188; 170.; 212	—
SECONDARY Upper Extremity Strength - Upper Body Strength Change	287.83; 277.0; 351.37; 315.47	—
SECONDARY PROMIS - Fatigue Short Form 8a	48.09; 49.31; 46.71; 50.43	—
SECONDARY PROMIS - Emotional Distress - Depression - Short Form 8a	47.21; 51.44; 45.31; 51.69	—
SECONDARY PROMIS - Pain Intensity - Short Form 3a	46.23; 45.08; 45.01; 45.43	—
SECONDARY PROMIS - Pain Interference - Short Form 8a	52.24; 52.06; 52.64; 51.96	—
SECONDARY PROMIS - Sleep Disturbance - Short Form 8a	48.71; 50.48; 48.87; 51.31	—
SECONDARY PROMIS - Emotional Support	55.77; 49.66; 55.01; 49.58	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03941600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.