ObesityNCT00955071
Effects of Exercise on Abdominal Obesity and Risk Factors for Cardiovascular Disease
A study testing Exercise: LVLI, Exercise: HVLI and Exercise: LVHI in people with Obesity and Metabolic Syndrome, run by Queen's University at 1 site in Canada.
Trial summary
The investigators will randomize abdominally obese men and women at increased health risk to one of the following 4 conditions: 1) No-exercise, wait list controls (C), 2) Low volume, low intensity exercise (LVLI), 3) High volume, low intensity exercise (HVLI), 4) Low volume, high intensity exercise (LVHI). Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome, Cardiovascular Disease
- What is being tested?
- Exercise: LVLI, Exercise: HVLI and Exercise: LVHI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to May 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women between 40 and 60 years of age. The lower age range for men and women is selected to help ensure recruitment of a sample with metabolic syndrome as prevalence of metabolic syndrome is significantly related to age. The selection of 60 years for the upper age range reflects concerns we have randomizing older adults to the high intensity exercise group wherein exercise at 75-80% of maximum may be difficult to achieve, and likely to be associated with increase orthopaedic injury and thus, poor compliance. We also considered lowering the lower age range from 40 to 35 years, but decided against doing so to increase the cost-effectiveness of recruitment (e.g., ensure a higher yield of those with metabolic syndrome).
- Abdominally obese (waist circumference greater than 88 and 102 cm for women and men respectively) and NCEP-ATPIII defined Metabolic Syndrome. Abdominal obesity for non-Caucasians will be determined using values suggested by the International Diabetes Federation.
- Sedentary lifestyle (planned physical activity for the purpose of health one day per week or less).
- Weight stable (± 2 kg) for 6 months prior to the beginning of the study.
- BMI less than 40 kg/m2 (Because a lifestyle-based intervention alone for obesity reduction is ideal for persons with a BMI less than 40 kg/m2).
Who cannot join
- Physical impairment which would make the intervention very difficult, or unsafe according to the patient's physician including history of myocardial infarction, stroke, coronary bypass surgery or angioplasty in the last 6 months; peripheral artery disease, unstable angina or ischemia.
- Diabetes.
- Current smokers.
- Alcohol consumption > 21 drinks per week.
- Plans to move from the area.
- Participating in another research study.
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- Clinically judged to be unsuitable for participation or adherence as determined by the participants physician.
- Inability or unwillingness to provide informed consent.
- For women, planned pregnancy in the next year.
Trial locations and contacts
1 site in 1 country.
Canada1 site
School of Kinesiology and Health Studies, Queen's University
Kingston, Ontario, K7L 3N6
About this study
Official title: Dose-response Effects of Exercise on Abdominal Obesity and Risk Factors for CVD in Men and Women.
The investigators will randomize abdominally obese men and women at increased health risk to one of the following 4 conditions: 1) No-exercise, wait list controls (C), 2) Low volume, low intensity exercise (LVLI), 3) High volume, low intensity exercise (HVLI), 4) Low volume, high intensity exercise (LVHI).
The primary aim of the trial is to determine the effects of varying exercise dose (energy expenditure, kcal) or intensity (relative to VO2max (cardiorespiratory fitness)) on waist circumference and glucose tolerance. The investigators will test the following hypotheses: 1) That the reduction in waist circumference and improvement in glucose tolerance in response to all treatments will be greater than controls. 2) That reduction in waist circumference and improvement in glucose tolerance in HVLI and LVHI will be greater than LVLI. 3) That hypotheses 1 and 2 are true independent of gender.
- Conditions
- Obesity, Metabolic Syndrome, Cardiovascular Disease
- Being tested
- Exercise: LVLI, Exercise: HVLI, Exercise: LVHI
- Keywords
- exercise, physical activity, diet, metabolic risk, visceral fat, Insulin Resistance
- Medical subject headings
- Obesity, Metabolic Syndrome, Cardiovascular Diseases, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise: LVLIOther
low volume, low intensity
Exercise: HVLIOther
high volume, low intensity
Exercise: LVHIOther
low volume, high intensity
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Exercise: LVLI | Active comparator | low volume, low intensity Receives: Other: Exercise: LVLI |
| Exercise: HVLI | Active comparator | high volume, low intensity Receives: Other: Exercise: HVLI |
| Exercise: LVHI | Active comparator | low volume, high intensity Receives: Other: Exercise: LVHI |
What is being measured
The primary outcome is the main question the study is designed to answer.
waist circumference
Measured: 6 months
2-hour glucose
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Bob Ross, Queen's University
- Investigators
- Robert Ross, PhD, Principal investigator, Queen's UniversityRobert Hudson, MD,PhD, Principal investigator, Queen's UniversityMiu Lam, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955071
- Sponsor's protocol ID
- Ross 2009
- Status last verified
- Aug 2013
- First submitted
- 4 Aug 2009
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cowan TE, Brennan AM, Stotz PJ, Clarke J, Lamarche B, Ross R. Separate Effects of Exercise Amount and Intensity on Adipose Tissue and Skeletal Muscle Mass in Adults with Abdominal Obesity. Obesity (Silver Spring). 2018 Nov;26(11):1696-1703. doi: 10.1002/oby.22304. Epub 2018 Sep 27.
PubMed 30261125Ross R, Hudson R, Stotz PJ, Lam M. Effects of exercise amount and intensity on abdominal obesity and glucose tolerance in obese adults: a randomized trial. Ann Intern Med. 2015 Mar 3;162(5):325-34. doi: 10.7326/M14-1189.
PubMed 25732273Ross R, Hudson R, Day AG, Lam M. Dose-response effects of exercise on abdominal obesity and risk factors for cardiovascular disease in adults: study rationale, design and methods. Contemp Clin Trials. 2013 Jan;34(1):155-60. doi: 10.1016/j.cct.2012.10.010. Epub 2012 Nov 1.
PubMed 23123790
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Effects of Exercise on Abdominal Obesity and Risk Factors for CVD in Men and Women.
- ClinicalTrials.gov ID
- NCT00955071
- Acronym / sponsor ID
- Ross 2009
- Conditions
- Obesity, Metabolic Syndrome, Cardiovascular Disease
- Keywords
- exercise, physical activity, diet, metabolic risk, visceral fat, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Aug 2009 (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 investigators will randomize abdominally obese men and women at increased health risk to one of the following 4 conditions: 1) No-exercise, wait list controls (C), 2) Low volume, low intensity exercise (LVLI), 3) High volume, low intensity exercise (HVLI), 4) Low volume, high intensity exercise (LVHI).
The primary aim of the trial is to determine the effects of varying exercise dose (energy expenditure, kcal) or intensity (relative to VO2max (cardiorespiratory fitness)) on waist circumference and glucose tolerance. The investigators will test the following hypotheses: 1) That the reduction in waist circumference and improvement in glucose tolerance in response to all treatments will be greater than controls. 2) That reduction in waist circumference and improvement in glucose tolerance in HVLI and LVHI will be greater than LVLI. 3) That hypotheses 1 and 2 are true independent of gender.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Exercise: LVLI | Active comparator | Other: Exercise: LVLIlow volume, low intensity |
| Exercise: HVLI | Active comparator | Other: Exercise: HVLIhigh volume, low intensity |
| Exercise: LVHI | Active comparator | Other: Exercise: LVHIlow volume, high intensity |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women between 40 and 60 years of age. The lower age range for men and women is selected to help ensure recruitment of a sample with metabolic syndrome as prevalence of metabolic syndrome is significantly related to age. The selection of 60 years for the upper age range reflects concerns we have randomizing older adults to the high intensity exercise group wherein exercise at 75-80% of maximum may be difficult to achieve, and likely to be associated with increase orthopaedic injury and thus, poor compliance. We also considered lowering the lower age range from 40 to 35 years, but decided against doing so to increase the cost-effectiveness of recruitment (e.g., ensure a higher yield of those with metabolic syndrome).
- Abdominally obese (waist circumference greater than 88 and 102 cm for women and men respectively) and NCEP-ATPIII defined Metabolic Syndrome. Abdominal obesity for non-Caucasians will be determined using values suggested by the International Diabetes Federation.
- Sedentary lifestyle (planned physical activity for the purpose of health one day per week or less).
- Weight stable (± 2 kg) for 6 months prior to the beginning of the study.
- BMI less than 40 kg/m2 (Because a lifestyle-based intervention alone for obesity reduction is ideal for persons with a BMI less than 40 kg/m2).
Key exclusion criteria (9 listed)
- Physical impairment which would make the intervention very difficult, or unsafe according to the patient's physician including history of myocardial infarction, stroke, coronary bypass surgery or angioplasty in the last 6 months; peripheral artery disease, unstable angina or ischemia.
- Diabetes.
- Current smokers.
- Alcohol consumption > 21 drinks per week.
- Plans to move from the area.
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 |
|---|---|---|
| Exercise: LVLIlow volume, low intensity | Other | Exercise: LVLI |
| Exercise: HVLIhigh volume, low intensity | Other | Exercise: HVLI |
| Exercise: LVHIlow volume, high intensity | Other | Exercise: LVHI |
Primary outcome
waist circumference
Time frame: 6 months
2-hour glucose
Time frame: 6 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 2 Aug 2013.
- Derived from this study: PubMed 30261125Cowan TE, Brennan AM, Stotz PJ, Clarke J, Lamarche B, Ross R. Separate Effects of Exercise Amount and Intensity on Adipose Tissue and Skeletal Muscle Mass in Adults with Abdominal Obesity. Obesity (Silver Spring). 2018 Nov;26(11):1696-1703. doi: 10.1002/oby.22304. Epub 2018 Sep 27.
- Derived from this study: PubMed 25732273Ross R, Hudson R, Stotz PJ, Lam M. Effects of exercise amount and intensity on abdominal obesity and glucose tolerance in obese adults: a randomized trial. Ann Intern Med. 2015 Mar 3;162(5):325-34. doi: 10.7326/M14-1189.
- Derived from this study: PubMed 23123790Ross R, Hudson R, Day AG, Lam M. Dose-response effects of exercise on abdominal obesity and risk factors for cardiovascular disease in adults: study rationale, design and methods. Contemp Clin Trials. 2013 Jan;34(1):155-60. doi: 10.1016/j.cct.2012.10.010. Epub 2012 Nov 1.
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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.
Robert Ross, PhD principal investigator
Queen's University
Robert Hudson, MD,PhD principal investigator
Queen's University
Miu Lam, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise: LVLI, Exercise: HVLI and Exercise: LVHI in people with Obesity and Metabolic Syndrome, run by Queen's 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 5 inclusion and 9 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 2 Aug 2013. 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?
waist circumference (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00955071, which also lists 3 linked publications.
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 2 Aug 2013.