NCT00535210

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

3.7 years

First QC Date

September 24, 2007

Last Update Submit

May 8, 2017

Conditions

Keywords

spinal cord injuryexercise rehabilitationinpatientRCTphysical function

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is physical function. This outcome will be measured before and after the program.

    6 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

1

OTHER
Behavioral: Cardiovascular training

2

OTHER
Behavioral: Balance training

Interventions

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.

1

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.

2

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Sustained a traumatic spinal cord injury,
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GF Strong Rehab Research Lab

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Janice Eng, Ph.D

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • William Miller, Ph.D

    University of British Columbia

    STUDY DIRECTOR
  • Andrei Krassioukov, Ph.D

    University of British Columbia

    STUDY DIRECTOR
  • Chihya Hung

    University of British Columbia

    STUDY CHAIR
  • Amira Tawashy

    University of British Columbia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

September 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations