The Effect of an Exercise Program on Physical Function After a Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cardiovascular training
Balance training
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, exercise rehabilitation, inpatient, RCT, physical function
Eligibility Criteria
Inclusion Criteria:
- Sustained a traumatic spinal cord injury,
- 16-50 years of age,
- Able to push a manual wheelchair and arm ergometer,
- Able to participate in exercise three times per week for 30 minutes,
- Able to follow English instructions.
Exclusion Criteria:
- Unstable cardiovascular status (congestive heart failure, uncontrolled hypertension, uncontrolled atrial fibrillation, or left ventricular failure),
- Significant musculo-skeletal problems (e.g., rheumatoid arthritis) or neurological conditions (e.g., Parkinson's disease) due to conditions other than spinal cord injury,
- Increased pain with exercise.
Sites / Locations
- GF Strong Rehab Research Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
The primary outcome is physical function. This outcome will be measured before and after the program.
Secondary Outcome Measures
Secondary outcomes include sitting balance and blood pressure in response to changes in position. Both these measures will be evaluated before and after the program.
Full Information
NCT ID
NCT00535210
First Posted
September 24, 2007
Last Updated
May 8, 2017
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00535210
Brief Title
The Effect of an Exercise Program on Physical Function After a Spinal Cord Injury
Official Title
The Effects of a Group Exercise Program on Function in Spinal Cord Injury Rehabilitation: A Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Unsuccessful recruiting patients, never got beyond pilot testing of patients
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study would focus on adding a group exercise program to the usual therapy delivered in the hospital. We propose to design an exercise program that would be 30 minutes in length, 3 times per week. A medical doctor and physiotherapist would oversee the design and monitoring of the program.
We believe that this program will: 1) Increase the potential for better health, thus improving independence and quality of life; 2) Help people make the move from therapist run exercise to self management of exercise; 3) Engage the patient in the therapy process and place an expectation of active participation on the client; and 4) Promote physical activity as part of a healthy lifestyle.
Detailed Description
In total 30 participants admitted for spinal cord injury rehabilitation at GF Strong Rehabilitation Centre will be randomly assigned to either cardiovascular training group or balance training group. The cardiovascular training group will receive their usual therapy plus 3 days of 30 minutes of exercise per week. This program will last for 6 weeks while the participant is in the hospital. The cardiovascular training program will include pushing and pulling on pulleys, wheeling over mats, punching a boxing bag, and using an arm ergometer. The balance training group will receive their usual therapy plus 3 days of 30 minutes of sitting balance activities. This program will last for 6 weeks while the participant is in the hospital. The balance training program will include sitting on mats - moving arm support from in front of the body to behind body, moving from sitting to lying and back up, and catching soft foam ball thrown directly to centre of chest and throwing it back.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury, exercise rehabilitation, inpatient, RCT, physical function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Title
2
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Cardiovascular training
Intervention Description
The cardiovascular training group will receive their usual therapy plus 3 days of 30 minutes of exercise per week. This program will last for 6 weeks while the participant is in the hospital. The cardiovascular training program will include pushing and pulling on pulleys, wheeling over mats, punching a boxing bag, and using an arm ergometer. The balance training group will receive their usual therapy plus 3 days of 30 minutes of sitting balance activities. This program will last for 6 weeks while the participant is in the hospital.
Intervention Type
Behavioral
Intervention Name(s)
Balance training
Intervention Description
The balance training group will receive their usual therapy plus 3 days of 30 minutes of sitting balance activities. This program will last for 6 weeks while the participant is in the hospital. The balance training program will include sitting on mats - moving arm support from in front of the body to behind body, moving from sitting to lying and back up, and catching soft foam ball thrown directly to centre of chest and throwing it back.
Primary Outcome Measure Information:
Title
The primary outcome is physical function. This outcome will be measured before and after the program.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary outcomes include sitting balance and blood pressure in response to changes in position. Both these measures will be evaluated before and after the program.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sustained a traumatic spinal cord injury,
16-50 years of age,
Able to push a manual wheelchair and arm ergometer,
Able to participate in exercise three times per week for 30 minutes,
Able to follow English instructions.
Exclusion Criteria:
Unstable cardiovascular status (congestive heart failure, uncontrolled hypertension, uncontrolled atrial fibrillation, or left ventricular failure),
Significant musculo-skeletal problems (e.g., rheumatoid arthritis) or neurological conditions (e.g., Parkinson's disease) due to conditions other than spinal cord injury,
Increased pain with exercise.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Eng, Ph.D
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Miller, Ph.D
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrei Krassioukov, Ph.D
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chihya Hung
Organizational Affiliation
University of British Columbia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amira Tawashy
Organizational Affiliation
University of British Columbia
Official's Role
Study Chair
Facility Information:
Facility Name
GF Strong Rehab Research Lab
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
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The Effect of an Exercise Program on Physical Function After a Spinal Cord Injury
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