Mobility LimitationHealthyStepsNCT01740505
HealthySteps: Exercise for Older Adults With Mobility Limitation
A study testing Timing and Coordination, Aerobic Walking and Stretching and Relaxation in people with Mobility Limitation, run by Simon Fraser University at 1 site in Canada.
Trial summary
This study will compare three different exercise programs in older adults who report difficulty walking and will determine if the programs improve walking. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Timing and Coordination, Aerobic Walking and Stretching and Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: 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.
- Conditions
- Mobility Limitation
- Being tested
- Timing and Coordination, Aerobic Walking, Stretching and Relaxation
- Keywords
- energy cost of walking, energy metabolism, aged, older adult, exercise, gait, walking, aerobic, motor skill
- Medical subject headings
- Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing and CoordinationBehavioural
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.
Aerobic WalkingBehavioural
Outdoor walking with progressive increases in exercise intensity. Small-group 60-minute classes twice weekly for 12 weeks.
Stretching and RelaxationBehavioural
Full-body stretching, range-of-motion exercises, and relaxation techniques. No specific gait training. Small-group 60-minute classes twice weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Timing and Coordination | Experimental | Not described Receives: Behavioral: Timing and Coordination |
| Aerobic Walking | Experimental | Not described Receives: Behavioral: Aerobic Walking |
| Stretching and Relaxation | Active comparator | Not described Receives: Behavioral: Stretching and Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy cost of walking
assessed by oxygen consumption during treadmill and overground walking
Measured: 12 weeks
fatigue and fatigability
assessed by questionnaire, rated perceived exertion during walking, and decrements in walking performance over time.
Measured: 12 weeks
daily activity
assessed by accelerometry and the Physical Activity Scale for the Elderly
Measured: 12 weeks
life-space mobility
assessed by life-space mobility questionnaire
Measured: 12 weeks
endurance
assessed by the long-distance corridor walk
Measured: 12 weeks
physical function
assessed by standing balance, gait speed, and chair stands
Measured: 12 weeks
Secondary outcomes (6)
energy cost of walking
assessed by oxygen consumption during treadmill and overground walking
Measured: 24 weeks
fatigue and fatigability
assessed by questionnaire, rated perceived exertion during walking, and decrements in walking performance over time
Measured: 24 weeks
daily activity
assessed by accelerometry and the Physical Activity Scale for the Elderly
Measured: 24 weeks
life-space mobility
assessed by the life-space mobility questionnaire
Measured: 24 weeks
endurance
assessed by the long-distance corridor walk
Measured: 24 weeks
physical function
assessed by standing balance, gait speed, and chair stands
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Collaborators
- Drummond Foundation
- Responsible party
- Principal investigator, Dawn C. Mackey, Simon Fraser University
- Investigators
- Dawn C Mackey, PhD, Principal investigator, Simon Fraser University; Vancouver Coastal Health Research Institute, Centre for Hip Health and Mobility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740505
- Sponsor's protocol ID
- DFMG-001
- Acronym
- HealthySteps
- Status last verified
- Jan 2015
- First submitted
- 23 Nov 2012
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HealthySteps: A Pilot Randomized Controlled Trial of Exercise to Improve Walking Energetics, Fatigue, and Activity in Older Adults With Mobility Limitation
- ClinicalTrials.gov ID
- NCT01740505
- Acronym / sponsor ID
- HealthySteps / DFMG-001
- Conditions
- Mobility Limitation
- Keywords
- energy cost of walking, energy metabolism, aged, older adult, exercise, gait, walking, aerobic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Collaborators
- Drummond Foundation
- Study start
- Jan 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare three different exercise programs in older adults who report difficulty walking and will determine if the programs improve walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Timing and Coordination | Experimental | Behavioral: Timing and Coordination |
| Aerobic Walking | Experimental | Behavioral: Aerobic Walking |
| Stretching and Relaxation | Active comparator | Behavioral: Stretching and Relaxation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timing and CoordinationThis 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. | Behavioural | Timing and Coordination |
| Aerobic WalkingOutdoor walking with progressive increases in exercise intensity. Small-group 60-minute classes twice weekly for 12 weeks. | Behavioural | Aerobic Walking |
| Stretching and RelaxationFull-body stretching, range-of-motion exercises, and relaxation techniques. No specific gait training. Small-group 60-minute classes twice weekly for 12 weeks. | Behavioural | Stretching and Relaxation |
Primary outcome
energy cost of walking
Time frame: 12 weeks
assessed by oxygen consumption during treadmill and overground walking
fatigue and fatigability
Time frame: 12 weeks
assessed by questionnaire, rated perceived exertion during walking, and decrements in walking performance over time.
daily activity
Time frame: 12 weeks
assessed by accelerometry and the Physical Activity Scale for the Elderly
life-space mobility
Time frame: 12 weeks
assessed by life-space mobility questionnaire
endurance
Time frame: 12 weeks
assessed by the long-distance corridor walk
physical function
Time frame: 12 weeks
assessed by standing balance, gait speed, and chair stands
6 secondary outcomes
energy cost of walking
Time frame: 24 weeks
fatigue and fatigability
Time frame: 24 weeks
daily activity
Time frame: 24 weeks
life-space mobility
Time frame: 24 weeks
endurance
Time frame: 24 weeks
physical function
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn C Mackey, PhD principal investigator
Simon Fraser University; Vancouver Coastal Health Research Institute, Centre for Hip Health and Mobility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing and Coordination, Aerobic Walking and Stretching and Relaxation in people with Mobility Limitation, run by Simon Fraser University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
energy cost of walking (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.