- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01740505
HealthySteps: Exercise for Older Adults With Mobility Limitation (HealthySteps)
January 19, 2015 updated by: Dawn C. Mackey, Simon Fraser University
HealthySteps: A Pilot Randomized Controlled Trial of Exercise to Improve Walking Energetics, Fatigue, and Activity in Older Adults With Mobility Limitation
This study will compare three different exercise programs in older adults who report difficulty walking and will determine if the programs improve walking.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women who live in the lower mainland (greater Vancouver) area of British Columbia
- Aged 65 years or older
- Living independently in their own home
- Report mobility limitation, defined as any difficulty walking one-quarter mile (about 2-3 blocks) outside on level ground or climbing one flight of stairs (about 10 steps) without resting because of a health or physical problem
Exclusion Criteria:
- Have a current medical condition for which exercise is contraindicated
- Have participated in an exercise intervention study in the past 6 months
- Do not have adequate cognitive function to provide informed consent and participate fully in the study
- Do not speak and understand English fluently
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Timing and Coordination
|
This intervention is based on progressively difficult stepping and walking patterns that promote the timing and coordination of stepping within the gait cycle.
Small-group 60-minute classes twice weekly for 12 weeks.
|
Experimental: Aerobic Walking
|
Outdoor walking with progressive increases in exercise intensity.
Small-group 60-minute classes twice weekly for 12 weeks.
|
Active Comparator: Stretching and Relaxation
|
Full-body stretching, range-of-motion exercises, and relaxation techniques.
No specific gait training.
Small-group 60-minute classes twice weekly for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
energy cost of walking
Time Frame: 12 weeks
|
assessed by oxygen consumption during treadmill and overground walking
|
12 weeks
|
fatigue and fatigability
Time Frame: 12 weeks
|
assessed by questionnaire, rated perceived exertion during walking, and decrements in walking performance over time.
|
12 weeks
|
daily activity
Time Frame: 12 weeks
|
assessed by accelerometry and the Physical Activity Scale for the Elderly
|
12 weeks
|
life-space mobility
Time Frame: 12 weeks
|
assessed by life-space mobility questionnaire
|
12 weeks
|
endurance
Time Frame: 12 weeks
|
assessed by the long-distance corridor walk
|
12 weeks
|
physical function
Time Frame: 12 weeks
|
assessed by standing balance, gait speed, and chair stands
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
energy cost of walking
Time Frame: 24 weeks
|
assessed by oxygen consumption during treadmill and overground walking
|
24 weeks
|
fatigue and fatigability
Time Frame: 24 weeks
|
assessed by questionnaire, rated perceived exertion during walking, and decrements in walking performance over time
|
24 weeks
|
daily activity
Time Frame: 24 weeks
|
assessed by accelerometry and the Physical Activity Scale for the Elderly
|
24 weeks
|
life-space mobility
Time Frame: 24 weeks
|
assessed by the life-space mobility questionnaire
|
24 weeks
|
endurance
Time Frame: 24 weeks
|
assessed by the long-distance corridor walk
|
24 weeks
|
physical function
Time Frame: 24 weeks
|
assessed by standing balance, gait speed, and chair stands
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dawn C Mackey, PhD, Simon Fraser University; Vancouver Coastal Health Research Institute, Centre for Hip Health and Mobility
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
November 23, 2012
First Submitted That Met QC Criteria
November 29, 2012
First Posted (Estimate)
December 4, 2012
Study Record Updates
Last Update Posted (Estimate)
January 21, 2015
Last Update Submitted That Met QC Criteria
January 19, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DFMG-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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