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

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ClinicalTrials.gov Identifier: NCT03411720
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
J. Andrew Taylor, Spaulding Rehabilitation Hospital

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: FES Row Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : April 29, 2020
Estimated Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Depression [ Time Frame: Each week during the 4 months ]
    Difference between groups in depression symptom severity (Patient Health Questionnaire-9); Within-individual Correlation of exercise intensity with depression

  2. Pain Severity [ Time Frame: Each week during the 4 months ]
    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.

  3. Pain Interference [ Time Frame: Each week during the 4 months ]
    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.

  4. Anxiety [ Time Frame: Each week during the 4 months ]
    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.

  5. Satisfaction with Social Participation [ Time Frame: Each week during the 4 months ]
    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.

  6. Ability to participate in social roles [ Time Frame: Each week during the 4 months ]
    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.


Secondary Outcome Measures :
  1. Health Complications [ Time Frame: Each week during the 4 months ]
    Difference between groups in frequency of secondary health complications; Within-individual Correlation of exercise intensity with secondary health complications.

  2. Community Mobility [ Time Frame: Each week during the 4 months ]
    Difference between groups in community mobility (Distance traveled each week); Within-individual Correlation of exercise intensity with community mobility.

  3. Social Connectivity: Frequency [ Time Frame: Each week during the 4 months ]
    Difference between groups in social connectivity (Frequency of phone calls and text messages); Within-individual Correlation of exercise intensity with frequency of social connectivity.

  4. Social Connectivity: Reciprocity [ Time Frame: Each week during the 4 months ]
    Difference between groups in social connectivity (Reciprocity of phone calls and text messages); Within-individual Correlation of exercise intensity with reciprocity of social connectivity.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411720


Contacts
Contact: Hannah W Mercier, PhD 6177585505 hmercier@mgh.harvard.edu
Contact: Glen Picard, MA 6177585511 gpicard@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Network Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Hannah Mercier, PhD    617-758-5505    hmercier@mgh.harvard.edu   
Contact: Glen Picard, MS    6177585511    gpicard@partners.org   
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
The Craig H. Neilsen Foundation
Investigators
Principal Investigator: J. Andrew Taylor Spaulding Rehabilitation Hospital/Harvard Medical School

Responsible Party: J. Andrew Taylor, Director, Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03411720     History of Changes
Other Study ID Numbers: 2017D006049
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System