Physical Activity Guidelines for People With Spinal Cord Injury (SCI)

This study has been completed.
Sponsor:
Collaborator:
Rick Hansen Foundation
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01368172
First received: June 6, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The first evidence-based physical activity guidelines for people with spinal cord injury were released in March, 2011. This project will evaluate the implementation of the new physical activity guidelines in a community exercise setting in Hamilton, Ontario. The investigators hypothesize that persons who follow the guidelines will experience increased aerobic fitness and muscle strength. The investigators also hypothesize that participants will find the guidelines easy to follow and that their self-efficacy for participating in physical activity will be improved following the study period.


Condition Intervention Phase
Spinal Cord Injury
Behavioral: Physical Activity Guidelines
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Implementation and Evaluation of the New Physical Activity Guidelines for People With Spinal Cord Injury.

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Physical Fitness [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Peak VO2 tests will be done on a cycle ergometer to assess aerobic capacity/endurance, and peak strength will be measured on accessible weight-training equipment.


Secondary Outcome Measures:
  • Self-efficacy for achieving the physical activity guidelines [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Assessed through questionnaire.

  • Adherence to physical activity guidelines [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Assessed through enrolment records


Enrollment: 30
Study Start Date: July 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Activity Guidelines
Participants randomized to this arm received training/guidance on following the physical activity guidelines for adults with spinal cord injury
Behavioral: Physical Activity Guidelines
Participants in the Physical Activity Guidelines Arm will be asked to participate in at least 20 minutes of moderate to heavy intensity aerobic activity 2 times per week as well as strength training exercises (moderate intensity) 2 times per week. The Control Arm will not be supervised to follow the physical activity guidelines
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults with spinal cord injury who have been given clearance to exercise by their primary care physician (or healthcare team)

Exclusion Criteria:

  • ventilatory support
  • inability to voluntarily participate in upper body exercises
  • inability to communicate in English
  • ongoing infection
  • unstable autonomic dysreflexia
  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: NCT01368172

Locations
Canada, Ontario
Centre for Health Promotion and Rehabilitation, McMaster University
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
Rick Hansen Foundation
Investigators
Principal Investigator: Audrey Hicks, PhD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01368172     History of Changes
Other Study ID Numbers: HicksPAGs
Study First Received: June 6, 2011
Last Updated: April 7, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
spinal cord injury
physical activity
physical fitness

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

ClinicalTrials.gov processed this record on September 22, 2014