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Completed

NCT Number: NCT03411720

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Network

Cambridge, Massachusetts, 02139, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FES Row Training

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2018
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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