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

NCT03411720 | Completed

• 1 other identifier: 2017D006049
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Health Complications

  Each week during the 4 months

• Community Mobility

  Each week during the 4 months

• Social Connectivity: Frequency

  Each week during the 4 months

• Social Connectivity: Reciprocity

  Each week during the 4 months

Study Arms (3)

FES-row-training

EXPERIMENTAL

Subjects will perform 4 months of FES-row-raining

Other: FES Row Training

Wait-list time control

OTHER

Subjects will wait 4 months before performing being allowed to engage in 4 months of FES-row-training

Other: FES Row Training

Arms-only-row-training

ACTIVE COMPARATOR

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

Interventions

FES Row Training OTHER

Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body

Arms-only-row-training; FES-row-training; Wait-list time control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Spaulding Rehabilitation Network

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• J. Andrew Taylor

  Spaulding Rehabilitation Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiovascular Research Laboratory

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 26, 2018
• Study Start: February 28, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)