The Effect of an Exercise Program on Physical Function After a Spinal Cord Injury

This study has been terminated.
(Unsuccessful recruiting patients, never got beyond pilot testing of patients)
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00535210
First received: September 24, 2007
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Spinal Cord Injury
Behavioral: Cardiovascular training
Behavioral: Balance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effects of a Group Exercise Program on Function in Spinal Cord Injury Rehabilitation: A Pilot Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The primary outcome is physical function. This outcome will be measured before and after the program. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: September 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 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.
2 Behavioral: 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.

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

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535210

Locations
Canada, British Columbia
GF Strong Rehab Research Lab
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Janice Eng, Ph.D University of British Columbia
Study Director: William Miller, Ph.D University of British Columbia
Study Director: Andrei Krassioukov, Ph.D University of British Columbia
Study Chair: Chihya Hung University of British Columbia
Study Chair: Amira Tawashy University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00535210     History of Changes
Other Study ID Numbers: H07-01073
Study First Received: September 24, 2007
Last Updated: January 29, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
spinal cord injury
exercise rehabilitation
inpatient
RCT
physical function

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 29, 2014