Feasibility of Exercise and Spinal Cord Injury

NCT03941600 | Completed Results

• 2 other identifiers: 201809174K12HD055931
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

occupational therapy; exercise

Outcome Measures

Primary Outcomes (4)

• VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)

  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.

  Baseline and Up to 4 weeks post intervention

• DEXA - Body Composition Overall Body Fat % Change

  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.

  Baseline and Up to 4 weeks post intervention

• Metabolic Blood Chemistries - HbA1c Level Change

  Blood draws will be completed to measure HbA1c levels in %. Participants will fast 8-10 hours prior to blood draw.

  Baseline and Up to 4 weeks post intervention

• Metabolic Blood Chemistries - Cholesterol Change

  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.

  Baseline and Up to 4 weeks post interventions

Secondary Outcomes (7)

• Upper Extremity Strength - Upper Body Strength Change

  Baseline and Up to 4 weeks post intervention

• PROMIS - Fatigue Short Form 8a

  Baseline and Up to 4 weeks post intervention

• PROMIS - Emotional Distress - Depression - Short Form 8a

  Baseline and Up to 4 weeks post intervention

• PROMIS - Pain Intensity - Short Form 3a

  Baseline and Up to 4 weeks post intervention

• PROMIS - Pain Interference - Short Form 8a

  Baseline and Up to 4 weeks post intervention

Study Arms (2)

Community-based Exercise Intervention group (CBEI)

ACTIVE COMPARATOR

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

Behavioral: Community-based Exercise Intervention group (CBE)

Exercise Education Control group (EEG)

PLACEBO COMPARATOR

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

Behavioral: Exercise Education Control group (EEG)

Interventions

Community-based Exercise Intervention group (CBE) BEHAVIORAL

The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.

Community-based Exercise Intervention group (CBEI)

Exercise Education Control group (EEG) BEHAVIORAL

The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.

Exercise Education Control group (EEG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of SCI
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (34)

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  BACKGROUND

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MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Results Point of Contact

• Title: Dr. Kerri Morgan
• Organization: Washington University School of Medicine

morgank@wustl.edu

314-286-1659

Study Officials

• Kerri A Morgan, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Occupational Therapy and Neurology

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: May 8, 2019
• Study Start: April 10, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: February 17, 2023
• Results First Posted: February 17, 2023

Record last verified: 2023-01

Locations

US (1)