Cardiac DiseasesPhase 2/3NCT00281424
Increasing Walking Following Cardiac Rehabilitation
A Phase 2/3 study testing pedometer in people with Cardiac Diseases and Walking, run by University of Alberta at 1 site in Canada.
Trial summary
The purpose of the project was to test the widely endorsed assumption that pedometers produce or encourage more physical activity participation in the form of walking. The investigators hypothesized that pedometers would not increase the amount of walking cardiac patients participated in after their cardiac… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Diseases, Walking
- What is being tested?
- pedometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Jan 2009
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients referred to the Northern Alberta Cardiac Rehabilitation Program
- Patients who are willing to participate
- Are able to read English
- Patients who are able to walk at 2.0 mph based on their exercise stress test results
Who cannot join
- patients unable to walk or walking contra-indicated
- unwilling
- do not read English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Walking Following Completion of Cardiac Rehabilitation
The purpose of the project was to test the widely endorsed assumption that pedometers produce or encourage more physical activity participation in the form of walking. The investigators hypothesized that pedometers would not increase the amount of walking cardiac patients participated in after their cardiac rehabilitation program compared to patients without pedometers.
Read the detailed description
As evidenced by the media attention given to pedometers and recent physical activity promotional efforts focused on pedometers, people seem to think that owning a pedometer will influence activity levels.
However, an examination of a few social cognitive theories produces no theoretical rationale that would support any sustained positive influence of pedometers in the absence of some other conditional factor, such as a behavioural goal or a social support system. We believe that once people determine how many steps their usual routes and daily activity typically amounts to, that the pedometer will no longer be used. We based our contentions on two theories: self efficacy theory (Bandura, 1986;1997) and self-determination theory (Deci \& Ryan, 2000).
- Conditions
- Cardiac Diseases, Walking
- Being tested
- pedometer
- Keywords
- exercise adherence, cardiac patients, walking
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedometerDevice
gave pedometer and info
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | no pedometer |
| pedometer | Experimental | given pedometer Receives: Device: pedometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity behaviour
Measured: months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startJun 2005
- Primary completionJan 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseasesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy M Rodgers, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281424
- Sponsor's protocol ID
- B-080105
- Status last verified
- Nov 2024
- First submitted
- 20 Jan 2006
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Walking Following Completion of Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT00281424
- Acronym / sponsor ID
- B-080105
- Conditions
- Cardiac Diseases, Walking
- Keywords
- exercise adherence, cardiac patients, walking
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 24 Jan 2006 (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.
The purpose of the project was to test the widely endorsed assumption that pedometers produce or encourage more physical activity participation in the form of walking. The investigators hypothesized that pedometers would not increase the amount of walking cardiac patients participated in after their cardiac rehabilitation program compared to patients without pedometers.
Detailed description
As evidenced by the media attention given to pedometers and recent physical activity promotional efforts focused on pedometers, people seem to think that owning a pedometer will influence activity levels.
However, an examination of a few social cognitive theories produces no theoretical rationale that would support any sustained positive influence of pedometers in the absence of some other conditional factor, such as a behavioural goal or a social support system. We believe that once people determine how many steps their usual routes and daily activity typically amounts to, that the pedometer will no longer be used. We based our contentions on two theories: self efficacy theory (Bandura, 1986;1997) and self-determination theory (Deci \& Ryan, 2000).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –no pedometer |
| pedometer | Experimental | Device: pedometergiven pedometer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All patients referred to the Northern Alberta Cardiac Rehabilitation Program
- Patients who are willing to participate
- Are able to read English
- Patients who are able to walk at 2.0 mph based on their exercise stress test results
Key exclusion criteria (3 listed)
- patients unable to walk or walking contra-indicated
- unwilling
- do not read English
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 |
|---|---|---|
| pedometergave pedometer and info | Device | pedometer |
Primary outcome
Physical activity behaviour
Time frame: months
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 6 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Cardiac Diseases
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Wendy M Rodgers, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing pedometer in people with Cardiac Diseases and Walking, run by University of Alberta 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 3 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 6 Nov 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical activity behaviour (time frame: months). 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 6 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.