Study Results
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View full resultsBasic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2019-04-10
2021-08-30
Brief Summary
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Detailed Description
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The project research aims are to:
1. Estimate improvements in physical function, cardio-metabolic health, and psychological well-being of participants enrolled in a CBEI compared to an education-only group.
2. Identify barriers, facilitators, and reasons for positive determinants for PwSCI to exercise in a community-based setting.
A single-blind pilot RCT will be conducted. Forty individuals with SCI will be recruited. Each participant will be randomized into either a 12-week CBEI (n=20) or an education control group (n=20). Participants' cardiorespiratory fitness, body composition, metabolic blood chemistries and strength will be assessed pre- (T1) and post- (T2) intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Community-based Exercise Intervention group (CBEI)
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE)
The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
Exercise Education Control group (EEG)
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG)
The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
Interventions
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Community-based Exercise Intervention group (CBE)
The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
Exercise Education Control group (EEG)
The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* Have written physician approval to participate in the study
* Ability to use upper extremities to exercise
* Participate in \< 60 minutes of moderate-intensity exercise per week in the last month
* Understand English at a sixth-grade level or higher
* Be able to follow multi-step instructions
* Independently provide informed consent
* Willing to participate in three assessments and 36 intervention sessions
Exclusion Criteria
* Have had cardiovascular complications within the past year
* Currently receive medical treatment for an acute upper extremity injury
* Have a Stage IV pressure injury
* Have a cognitive impairment that does not allow them to provide consent or follow multi-step directions.
18 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Kerri Morgan
Assistant Professor of Occupational Therapy and Neurology
Principal Investigators
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Kerri A Morgan, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Totosy de Zepetnek JO, Pelletier CA, Hicks AL, MacDonald MJ. Following the Physical Activity Guidelines for Adults With Spinal Cord Injury for 16 Weeks Does Not Improve Vascular Health: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Sep;96(9):1566-75. doi: 10.1016/j.apmr.2015.05.019. Epub 2015 Jun 10.
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Garcia-Masso X, Serra-Ano P, Garcia-Raffi LM, Sanchez-Perez EA, Lopez-Pascual J, Gonzalez LM. Validation of the use of Actigraph GT3X accelerometers to estimate energy expenditure in full time manual wheelchair users with spinal cord injury. Spinal Cord. 2013 Dec;51(12):898-903. doi: 10.1038/sc.2013.85. Epub 2013 Sep 3.
Morgan, K. A., Engsberg, J. R., & Klaesner, J. (2015). The testing of an instrumented wheelchair propulsion testing and training device. Journal of Physical Medicine, Rehabilitation and Disabilities, 1(003), 1-9.
Evans N, Wingo B, Sasso E, Hicks A, Gorgey AS, Harness E. Exercise Recommendations and Considerations for Persons With Spinal Cord Injury. Arch Phys Med Rehabil. 2015 Sep;96(9):1749-50. doi: 10.1016/j.apmr.2015.02.005. Epub 2015 Jul 18. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201809174
Identifier Type: -
Identifier Source: org_study_id
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