Clinical trial NCT03411720: Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function
Official title: Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2018-01-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Depression
timeFrame: Each week during the 4 months
measure: Pain Severity
timeFrame: Each week during the 4 months
measure: Pain Interference
timeFrame: Each week during the 4 months
measure: Anxiety
timeFrame: Each week during the 4 months
measure: Satisfaction with Social Participation
timeFrame: Each week during the 4 months
measure: Ability to participate in social roles
timeFrame: Each week during the 4 months
Secondary outcomes:
measure: Health Complications
timeFrame: Each week during the 4 months
measure: Community Mobility
timeFrame: Each week during the 4 months
measure: Social Connectivity: Frequency
timeFrame: Each week during the 4 months
measure: Social Connectivity: Reciprocity
timeFrame: Each week during the 4 months
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Spaulding Rehabilitation Network
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital/Harvard Medical School
name: J. Andrew Taylor
role: PRINCIPAL_INVESTIGATOR
References: