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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FES Row Training
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Spaulding Rehabilitation Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Active Comparator

Arm Label

FES-row-training

Wait-list time control

Arms-only-row-training

Arm Description

Subjects will perform 4 months of FES-row-raining

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

Subjects will perform 4 months of arms-only row training before being allowed to engage in 4 months of FES-row-training

Outcomes

Primary Outcome Measures

Depression
Difference between groups in depression symptom severity (Patient Health Questionnaire-9); Within-individual Correlation of exercise intensity with depression
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.
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.
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.
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.
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.

Secondary Outcome Measures

Health Complications
Difference between groups in frequency of secondary health complications; Within-individual Correlation of exercise intensity with secondary health complications.
Community Mobility
Difference between groups in community mobility (Distance traveled each week); Within-individual Correlation of exercise intensity with community mobility.
Social Connectivity: Frequency
Difference between groups in social connectivity (Frequency of phone calls and text messages); Within-individual Correlation of exercise intensity with frequency of social connectivity.
Social Connectivity: Reciprocity
Difference between groups in social connectivity (Reciprocity of phone calls and text messages); Within-individual Correlation of exercise intensity with reciprocity of social connectivity.

Full Information

First Posted
January 5, 2018
Last Updated
June 19, 2020
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03411720
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
The Craig H. Neilsen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FES-row-training
Arm Type
Experimental
Arm Description
Subjects will perform 4 months of FES-row-raining
Arm Title
Wait-list time control
Arm Type
Other
Arm Description
Subjects will wait 4 months before performing being allowed to engage in 4 months of FES-row-training
Arm Title
Arms-only-row-training
Arm Type
Active Comparator
Arm Description
Subjects will perform 4 months of arms-only row training before being allowed to engage in 4 months of FES-row-training
Intervention Type
Other
Intervention Name(s)
FES Row Training
Intervention Description
Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
Primary Outcome Measure Information:
Title
Depression
Description
Difference between groups in depression symptom severity (Patient Health Questionnaire-9); Within-individual Correlation of exercise intensity with depression
Time Frame
Each week during the 4 months
Title
Pain Severity
Description
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.
Time Frame
Each week during the 4 months
Title
Pain Interference
Description
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.
Time Frame
Each week during the 4 months
Title
Anxiety
Description
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.
Time Frame
Each week during the 4 months
Title
Satisfaction with Social Participation
Description
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.
Time Frame
Each week during the 4 months
Title
Ability to participate in social roles
Description
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.
Time Frame
Each week during the 4 months
Secondary Outcome Measure Information:
Title
Health Complications
Description
Difference between groups in frequency of secondary health complications; Within-individual Correlation of exercise intensity with secondary health complications.
Time Frame
Each week during the 4 months
Title
Community Mobility
Description
Difference between groups in community mobility (Distance traveled each week); Within-individual Correlation of exercise intensity with community mobility.
Time Frame
Each week during the 4 months
Title
Social Connectivity: Frequency
Description
Difference between groups in social connectivity (Frequency of phone calls and text messages); Within-individual Correlation of exercise intensity with frequency of social connectivity.
Time Frame
Each week during the 4 months
Title
Social Connectivity: Reciprocity
Description
Difference between groups in social connectivity (Reciprocity of phone calls and text messages); Within-individual Correlation of exercise intensity with reciprocity of social connectivity.
Time Frame
Each week during the 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Andrew Taylor
Organizational Affiliation
Spaulding Rehabilitation Hospital/Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Network
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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