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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00535210
Other study ID # H07-01073
Secondary ID
Status Terminated
Phase N/A
First received September 24, 2007
Last updated May 8, 2017
Start date September 2007
Est. completion date May 2011

Study information

Verified date May 2017
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender All
Age group 16 Years to 50 Years
Eligibility Inclusion Criteria:

1. Sustained a traumatic spinal cord injury,

2. 16-50 years of age,

3. Able to push a manual wheelchair and arm ergometer,

4. Able to participate in exercise three times per week for 30 minutes,

5. Able to follow English instructions.

Exclusion Criteria:

1. Unstable cardiovascular status (congestive heart failure, uncontrolled hypertension, uncontrolled atrial fibrillation, or left ventricular failure),

2. Significant musculo-skeletal problems (e.g., rheumatoid arthritis) or neurological conditions (e.g., Parkinson's disease) due to conditions other than spinal cord injury,

3. Increased pain with exercise.

Study Design


Intervention

Behavioral:
Cardiovascular training
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.
Balance training
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.

Locations

Country Name City State
Canada GF Strong Rehab Research Lab Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome is physical function. This outcome will be measured before and after the program. 6 months
Secondary 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. 6 months
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