Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function

Persons with spinal cord injury (SCI) are confronted with a multitude of psychological and physiological changes post-injury leading to seemingly insurmountable barriers to participating in daily life. After injury persons with SCI engage in fewer social interactions, spend more time sedentary, and are less likely to leave the home. This leads to restricted social participation that, in turn, contributes to greater psychological problems and negatively impacts the lives of adults with SCI. Intense, structured exercise has substantial potential benefits for improving psychosocial wellbeing among persons with SCI, but accessible exercise options are few and cannot achieve high intensities of whole-body exercise. This work will use approaches to overcome the barriers to intense exercise. The investigators will use hybrid functional electrical stimulation row training (FESRT) to allow for a more intense exercise stimulus, potentially having a greater impact on psychosocial wellbeing. There is initial evidence that persons with mobility impairments who are highly physically active demonstrate better psychosocial wellbeing compared with those who have low levels of physical activity. A limitation to understanding the influence of exercise on psychosocial wellbeing is the lack of robust and time-dependent measures. The investigators will use a smartphone-based research application to measure psychosocial well-being, thus decreasing self-report bias and capturing in-the-moment behavioral and self-report data.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: FES Row Training

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Spaulding Rehabilitation Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults (>18 years of age)

  • Be in good health (asymptomatic for acute treatable illness) and medically cleared to exercise
  • Own an iPhone or Android smartphone with the capacity to download and run the research platform (able to log into to the relevant app store, install the app on their own phone, and run the app).
  • Be able to understand, communicate with and be understood by research personnel or Interpreters
  • Be interested in participating and provide informed consent
  • Have a SCI with motor or sensory deficits and use a wheelchair as primary means of mobility
  • Have an injury level only as high as C4 to allow sufficient arm function for rowing

Exclusion Criteria:

• Participants will not have previously completed FESRT
• Acute illness
• Musculoskeletal injuries that have not healed completely
• Had heart surgery or are status post-myocardial infarction (MI) in the last 4 to 6 months, -Unstable angina
• Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg)
• uncontrolled dysrhythmias
• Recent history of congestive heart failure that has not been evaluated and effectively treated
• Severe stenotic or regurgitant valvular disease
• Hypertrophic cardiomyopathy
• Unhealed pressure ulcer Stage 2 or higher at relevant contact sites during exercise.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FES-row-training; Subjects will perform 4 months of FES-row-raining	Other: FES Row Training; Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
Other: Wait-list time control; Subjects will wait 4 months before performing being allowed to engage in 4 months of FES-row-training	Other: FES Row Training; Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
Active Comparator: Arms-only-row-training; Subjects will perform 4 months of arms-only row training before being allowed to engage in 4 months of FES-row-training	Other: FES Row Training; Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Difference between groups in depression symptom severity (Patient Health Questionnaire-9); Within-individual Correlation of exercise intensity with depression	Each week during the 4 months
Pain Severity	Difference between groups in pain severity, rated on a 0-10 scale ("0 being no pain and 10 being pain so severe you couldn't stand it"); Within-individual Correlation of exercise intensity with pain.	Each week during the 4 months
Pain Interference	Difference between groups in pain interference in daily life activities ("0. Not at all 1. A little bit 2. Moderately 3. Quite a bit 4. Extremely"); Within-individual Correlation of exercise intensity with pain.	Each week during the 4 months
Anxiety	Difference between groups in anxiety (Spinal Cord Injury Quality of Life Anxiety Short Form); Within-individual Correlation of exercise intensity with anxiety. Minimum score is 9, Maximum score is 45. Higher scores indicate higher anxiety.	Each week during the 4 months
Satisfaction with Social Participation	Difference between groups in satisfaction with social roles and activities (Spinal Cord Injury Quality of Life Satisfaction with Social Roles and Activities Short Form); Within-individual Correlation of exercise intensity with satisfaction with social participation. The Minimum score is 20 and the maximum score is 50. Higher values indicate greater satisfaction with social participation.	Each week during the 4 months
Ability to participate in social roles	Difference between groups in ability to participate in social roles and activities. Spinal Cord Injury Quality of Life Ability to Participate in Social Roles and Activities Short Form. Within-individual Correlation of exercise intensity with ability to participate in social roles. The Minimum score is 20 and the maximum score is 50. Higher values indicate greater satisfaction with social participation.	Each week during the 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Complications	Difference between groups in frequency of secondary health complications; Within-individual Correlation of exercise intensity with secondary health complications.	Each week during the 4 months
Community Mobility	Difference between groups in community mobility (Distance traveled each week); Within-individual Correlation of exercise intensity with community mobility.	Each week during the 4 months
Social Connectivity: Frequency	Difference between groups in social connectivity (Frequency of phone calls and text messages); Within-individual Correlation of exercise intensity with frequency of social connectivity.	Each week during the 4 months
Social Connectivity: Reciprocity	Difference between groups in social connectivity (Reciprocity of phone calls and text messages); Within-individual Correlation of exercise intensity with reciprocity of social connectivity.	Each week during the 4 months

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Collaborators: The Craig H. Neilsen Foundation
• Investigators: Principal Investigator: J. Andrew Taylor, Spaulding Rehabilitation Hospital/Harvard Medical School

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 2017D006049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No