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

NCT ID: NCT03411720

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2020-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

FES-row-training

Subjects will perform 4 months of FES-row-raining

Group Type: EXPERIMENTAL

FES Row Training

Intervention Type: OTHER

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

Group Type: OTHER

FES Row Training

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

FES Row Training

Intervention Type: OTHER

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

Interventions

FES Row Training

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Craig H. Neilsen Foundation

OTHER

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

J. Andrew Taylor

Director, Cardiovascular Research Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Andrew Taylor

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital/Harvard Medical School

Locations

Spaulding Rehabilitation Network

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

2017D006049

Identifier Type: -

Identifier Source: org_study_id