Feasibility of Exercise and Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Behavioral: Community-based Exercise Intervention group (CBE); Behavioral: Exercise Education Control group (EEG)

• Registration Number: NCT03941600
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2019-01-18
• Study Start: 2019-04-10
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Results First Submitted: 2022-11-18
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Results First Posted: 2023-02-17
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community-based Exercise Intervention group (CBEI)	Community-based Exercise Intervention group (CBE)	A group performing a 12-week guided exercise program at an accessible community health and wellness center
Exercise Education Control group (EEG)	Exercise Education Control group (EEG)	A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.

Primary Outcome Measures

Name	Time	Method
Metabolic Blood Chemistries - Cholesterol Change	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)	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	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	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 Outcome Measures

Name	Time	Method
Upper Extremity Strength - Upper Body Strength Change	Baseline and Up to 4 weeks post intervention	Strength will be measured via isotonic 1RM testing unilaterally on four upper-extremity exercises (chest press, back row, rickshaw, biceps flexion) using a BTE™ PrimusRS (BTE™, Hanover, MD). Data was organized into one single strength variable by summing the 4 left side upper extremity exercises together, then summing the 4 right side upper extremity exercises together, and finally taking those 2 totals (from left side and right side) and summing them into one strength variable. A higher number indicates more strength. The BTE™ PrimusRS uses an inch-pound (the torque of one pound of force applied to one inch of distance from the pivot) as it's unit of measurement.
PROMIS - Fatigue Short Form 8a	Baseline and Up to 4 weeks post intervention	Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue - assesses a range of self-reported fatigue symptoms over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "not at all (1)" to "very much (5)" with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild fatigue, a t-score of 60-70 indicates moderate fatigue and a t-score of 70 or above indicates severe fatigue.
PROMIS - Emotional Distress - Depression - Short Form 8a	Baseline and Up to 4 weeks post intervention	Patient Reported Outcomes Measurement Information System (PROMIS) Emotional distress - Depression - assesses self-reported negative mood, views of self, social cognition, as well as decreased positive affect and engagement over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "never (1)" to "always (5)" with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild depression, a t-score of 60-70 indicates moderate depression and a t-score of 70 or above indicates severe depression.
PROMIS - Pain Intensity - Short Form 3a	Baseline and Up to 4 weeks post intervention	Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity - assesses how much a person hurts over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "had no pain (1)" to "very severe (5)" with a raw score between 3 and 15. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild pain intensity, a t-score of 60-70 indicates moderate pain intensity and a t-score of 70 or above indicates severe pain intensity.
PROMIS - Pain Interference - Short Form 8a	Baseline and Up to 4 weeks post intervention	Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference - assesses self-reported consequences of pain on relevant aspects of one's life over the past 7 days, this includes how pain hinders engagement with social, cognitive, emotional, physical and recreational activities. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "not at all (1)" to "very much (5)" with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild pain interference, a t-score of 60-70 indicates moderate pain interference and a t-score of 70 or above indicates severe pain interference.
PROMIS - Sleep Disturbance - Short Form 8a	Baseline and Up to 4 weeks post intervention	Patient Reported Outcomes Measurement Information System (PROMIS) Sleep - assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "very poor (1)" to "very good (5)" with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild sleep disturbance, a t-score of 60-70 indicates moderate sleep disturbance and a t-score of 70 or above indicates severe sleep disturbance.
PROMIS - Emotional Support	Baseline and Up to 4 weeks post intervention	Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support - assesses perceived feelings of being cared for and valued as a person and having confident relationships. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "never (1)" to "always (5)". The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 40-60 indicates an average amount of emotional support, a t-score of 60-70 indicates high levels of emotional support, and a t-score of 70 or above indicates very high levels of emotional support.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States