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

Spinal Cord Injury Clinical Trial

Official title:

Implementation and Evaluation of the New Physical Activity Guidelines for People With Spinal Cord Injury.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368172
• Other study ID #: HicksPAGs
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2011
• Last updated: April 7, 2014
• Start date: July 2011
• Est. completion date: June 2013

Study information

• Verified date: April 2014
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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

Locations

Country	Name	City	State
Canada	Centre for Health Promotion and Rehabilitation, McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Rick Hansen Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Fitness	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.	4 months	No
Secondary	Self-efficacy for achieving the physical activity guidelines	Assessed through questionnaire.	4 months	No
Secondary	Adherence to physical activity guidelines	Assessed through enrolment records	4 months	No