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

The Effects of a Group Exercise Program on Function in Spinal Cord Injury Rehabilitation: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Behavioral: Cardiovascular training; Behavioral: Balance training

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • GF Strong Rehab Research Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome is physical function. This outcome will be measured before and after the program.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: September 24, 2007
• First Submitted That Met QC Criteria: September 25, 2007
• First Posted (ESTIMATE): September 26, 2007

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: RCT; physical function; spinal cord injury; inpatient; exercise rehabilitation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: H07-01073