Sedentary BehaviourPhase 1/2NCT00281385
Health and Psychological Outcomes of Lifestyle Versus Traditional Physical Activity
A Phase 1/2 study testing traditional vs. lifestyle exercise in people with Sedentary Behaviour and Adherence, run by University of Alberta at 1 site in Canada.
Trial summary
This study is a comparison of the traditional prescription versus the lifestyle exercise prescription in sedentary adults over 6 months. Biological and psychological parameters will be assessed over the 6 month study. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behaviour, Adherence, Traditional Exercise
- What is being tested?
- traditional vs. lifestyle exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25-65 years old
- exercise less than twice per month in the preceeding 6 months
- physician consent to participate
Who cannot join
- health problems
- exercise more than twice per month in the preceeding 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health and Psychological Outcomes of Lifestyle Versus Traditional Physical Activity- Study 1
This study is a comparison of the traditional prescription versus the lifestyle exercise prescription in sedentary adults over 6 months. Biological and psychological parameters will be assessed over the 6 month study. Biological indicators will be assessed pre and post including body composition, muscular strength, endurance, and flexibility, aerobic fitness, and blood tests. Psychological parameters will be assessed pre, mid, and post including self-efficacy, motivation, need satisfaction, physical self-description, leisure-time exercise, as well as all constructs from the thepry of planned behaviour.
- Being tested
- traditional vs. lifestyle exercise
- Keywords
- adherence, lifestyle, exercise, pedometer, training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional vs. lifestyle exerciseBehavioural
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviourStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Wendy M Rodgers, PhD., Principal investigator, University of AlbertaGordon J Bell, PhD, Principal investigator, University of AlbertaKerry Courneya, PhD, Principal investigator, University of AlbertaVicki J Harber, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281385
- Sponsor's protocol ID
- 2002-0422-02
- Other IDs
- CIHR
- Status last verified
- Nov 2024
- First submitted
- 20 Jan 2006
- Last updated
- 5 Nov 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Psychological Outcomes of Lifestyle Versus Traditional Physical Activity- Study 1
- ClinicalTrials.gov ID
- NCT00281385
- Acronym / sponsor ID
- 2002-0422-02
- Keywords
- adherence, lifestyle, exercise, pedometer, training
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- 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.
This study is a comparison of the traditional prescription versus the lifestyle exercise prescription in sedentary adults over 6 months. Biological and psychological parameters will be assessed over the 6 month study. Biological indicators will be assessed pre and post including body composition, muscular strength, endurance, and flexibility, aerobic fitness, and blood tests. Psychological parameters will be assessed pre, mid, and post including self-efficacy, motivation, need satisfaction, physical self-description, leisure-time exercise, as well as all constructs from the thepry of planned behaviour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 25-65 years old
- exercise less than twice per month in the preceeding 6 months
- physician consent to participate
Key exclusion criteria (2 listed)
- health problems
- exercise more than twice per month in the preceeding 6 months
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 |
|---|---|---|
| traditional vs. lifestyle exercise | Behavioural | – |
Primary outcome
Not reported in the source record.
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 5 Nov 2024.
Related trials for Sedentary Behaviour
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
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
Gordon J Bell, PhD principal investigator
University of Alberta
Kerry Courneya, 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 1/2 study testing traditional vs. lifestyle exercise in people with Sedentary Behaviour and Adherence, 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 3 inclusion and 2 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 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 5 Nov 2024.