- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01368172
Physical Activity Guidelines for People With Spinal Cord Injury (SCI)
April 7, 2014 updated by: McMaster University
Implementation and Evaluation of the New Physical Activity Guidelines for People With Spinal Cord Injury.
The first evidence-based physical activity guidelines for people with spinal cord injury were released in March, 2011.
This project will evaluate the implementation of the new physical activity guidelines in a community exercise setting in Hamilton, Ontario.
The investigators hypothesize that persons who follow the guidelines will experience increased aerobic fitness and muscle strength.
The investigators also hypothesize that participants will find the guidelines easy to follow and that their self-efficacy for participating in physical activity will be improved following the study period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Centre for Health Promotion and Rehabilitation, McMaster University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adults with spinal cord injury who have been given clearance to exercise by their primary care physician (or healthcare team)
Exclusion Criteria:
- ventilatory support
- inability to voluntarily participate in upper body exercises
- inability to communicate in English
- ongoing infection
- unstable autonomic dysreflexia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
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Experimental: Physical Activity Guidelines
Participants randomized to this arm received training/guidance on following the physical activity guidelines for adults with spinal cord injury
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Participants in the Physical Activity Guidelines Arm will be asked to participate in at least 20 minutes of moderate to heavy intensity aerobic activity 2 times per week as well as strength training exercises (moderate intensity) 2 times per week.
The Control Arm will not be supervised to follow the physical activity guidelines
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Fitness
Time Frame: 4 months
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Peak VO2 tests will be done on a cycle ergometer to assess aerobic capacity/endurance, and peak strength will be measured on accessible weight-training equipment.
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4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy for achieving the physical activity guidelines
Time Frame: 4 months
|
Assessed through questionnaire.
|
4 months
|
Adherence to physical activity guidelines
Time Frame: 4 months
|
Assessed through enrolment records
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
June 6, 2011
First Submitted That Met QC Criteria
June 6, 2011
First Posted (Estimate)
June 7, 2011
Study Record Updates
Last Update Posted (Estimate)
April 8, 2014
Last Update Submitted That Met QC Criteria
April 7, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HicksPAGs
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injury
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Taipei Veterans General Hospital, TaiwanThe Industrial Technology Research InstituteUnknownSpinal Cord Injuries | Complete Spinal Cord Injury | Incomplete Spinal Cord InjuryTaiwan
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University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingSCI - Spinal Cord Injury | Incomplete Spinal Cord InjuryUnited States
-
Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
-
NervGen PharmaRecruitingSpinal Cord Injuries | Chronic Spinal Cord Injury | Subacute Spinal Cord InjuryUnited States
-
MetroHealth Medical CenterNational Institute of Neurological Disorders and Stroke (NINDS); Case Western...RecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury CervicalUnited States
-
Kevin KilgoreNational Institute of Neurological Disorders and Stroke (NINDS); Case Western... and other collaboratorsRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury Cervical | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C5-C7 Level With Incomplete LesionUnited States
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The University of Texas Health Science Center,...TerminatedSpinal Cord Injuries | Cervical Spinal Cord Injury | Traumatic Spinal Cord CompressionUnited States
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S.Biomedics Co., Ltd.Yonsei University; Linical Co., Ltd.RecruitingSpinal Cord Injury, Acute | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C4 Level With Complete LesionKorea, Republic of
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StemCells, Inc.TerminatedStudy of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord InjuryCervical Spinal Cord Injury | Spine Injury | Cervical Spine InjuryUnited States, Canada
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Mahidol UniversityRecruitingSpinal Cord Injury | Incomplete Spinal Cord InjuryThailand
Clinical Trials on Physical Activity Guidelines
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Pennington Biomedical Research CenterCompleted
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Norwegian University of Science and TechnologyCompletedEssential HypertensionNorway
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University of TorontoCanadian Institutes of Health Research (CIHR)RecruitingSedentary Behavior | Metabolic DisturbanceCanada
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University of Missouri-ColumbiaCompletedExercise InterventionUnited States
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University of NottinghamCompletedPain | Arthritis | Osteoarthritis | Physical Activity | Knee Osteoarthritis | Motor Activity | Sedentary | GonarthritisUnited Kingdom
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University of TorontoWomen's College HospitalCompleted
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The University of Hong KongUnknownOverweight | Sedentary Lifestyle | Eating DisordersHong Kong
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University of AlbertaCompleted
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University of Texas at AustinNational Institute of Nursing Research (NINR)Recruiting
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University of ConnecticutCompletedPhysical Activity | Health BehaviorUnited States