Clinical trial NCT00535210: 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
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
exercise rehabilitation
inpatient
RCT
physical function
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 9
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome is physical function. This outcome will be measured before and after the program.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehab Research Lab
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Janice Eng, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: William Miller, Ph.D
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Andrei Krassioukov, Ph.D
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Chihya Hung
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Amira Tawashy
role: STUDY_CHAIR
References: