NCT01368172

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

1.9 years

First QC Date

June 6, 2011

Last Update Submit

April 7, 2014

Conditions

Keywords

spinal cord injuryphysical activityphysical fitness

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Self-efficacy for achieving the physical activity guidelines

    4 months

  • Adherence to physical activity guidelines

    4 months

Study Arms (2)

Physical Activity Guidelines

EXPERIMENTAL

Participants randomized to this arm received training/guidance on following the physical activity guidelines for adults with spinal cord injury

Behavioral: Physical Activity Guidelines

Control

NO INTERVENTION

Interventions

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

Physical Activity Guidelines

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Health Promotion and Rehabilitation, McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Spinal Cord InjuriesMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Audrey Hicks, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 7, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations