Effects of different intensities of exercise on health risk factors
| ISRCTN | ISRCTN43414825 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43414825 |
| ClinicalTrials.gov number | NCT00955071 |
| Secondary identifying numbers | MCT-190617 |
- Submission date
- 09/02/2010
- Registration date
- 11/02/2010
- Last edited
- 28/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Robert Ross
Scientific
Scientific
Queen's University
School of Kinesiology and Health Studies
28 Division Street
Kingston
K7L 3N6
Canada
| rossr@queensu.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Dose-response effects of exercise on abdominal obesity and risk factors for cardiovascular disease (CVD) in women and men |
| Study acronym | SERENA |
| Study objectives | The driving hypothesis is that the attenuation of health risk with exercise is largely explained by associated reductions in abdominal obesity, in particular visceral fat. Specifically, we will test the following hypotheses: 1. That by comparison to controls, all treatments will be associated with reduction in abdominal subcutaneous, visceral fat, liver fat and insulin resistance 2. That reduction in abdominal subcutaneous, visceral and liver fat and insulin resistance in high volume low intensity exercise (HVLI) and low volume high intensity exercise (LVHI) will be greater than low volume low intensity exercise (LVLI) 3. That hypotheses 1 and 2 are true independent of gender |
| Ethics approval(s) | Queens University, Faculty of Health Sciences Research Ethics Board (REB) approved on the 22nd July 2009 (ref: PHE-093-09) |
| Health condition(s) or problem(s) studied | Cardiometabolic risk |
| Intervention | The intervention (duration of treatment) will be six months and the negative energy balance will be induced by the increase in exercise alone (e.g., no caloric restriction). 1. No exercise, wait list control group 2. Low volume (180 kcal), low intensity (50%) exercise group 3. High volume (360 kcal), low intensity (50%) exercise group 4. Low volume (180 kcal), high intensity (75%) exercise group |
| Intervention type | Other |
| Primary outcome measure | Waist circumference and 2-hour glucose, measured at baseline, 16, 24 and 48 weeks |
| Secondary outcome measures | Measured at baseline, 16, 24 and 48 weeks: 1. Visceral fat 2. Metabolic syndrome variables (glucose, systolic and diastolic blood pressure, triglycerides and high density lipoprotein [HDL]-cholesterol) |
| Overall study start date | 01/09/2009 |
| Completion date | 31/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 320 |
| Key inclusion criteria | 1. 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 randomising 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 increased 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) 2. Abdominally obese (waist circumference greater than 88 and 102 cm for women and men respectively) and National Cholesterol Education Program, Adult Treatment Panel III (NCEP-ATPIII) defined metabolic syndrome. Abdominal obesity for non-Caucasians will be determined using values suggested by the International Diabetes Federation. 3. Sedentary lifestyle (planned physical activity for the purpose of health one day per week or less) 4. Weight stable (± 2 kg) for 6 months prior to the beginning of the study 5. Body mass index (BMI) less than 40 kg/m^2 (because a lifestyle-based intervention alone for obesity reduction is ideal for persons with a BMI less than 40 kg/m^2) |
| Key exclusion criteria | 1. 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 ischaemia 2. Diabetes 3. Current smokers 4. Alcohol consumption greater than 21 drinks per week 5. Plans to move from the area 6. Participating in another research study 7. Clinically judged to be unsuitable for participation or adherence as determined by the participants physician 8. Inability or unwillingness to provide informed consent 9. For women, planned pregnancy in the next year |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 31/08/2013 |
Locations
Countries of recruitment
- Canada
Study participating centre
Queen's University
Kingston
K7L 3N6
Canada
K7L 3N6
Canada
Sponsor information
Queen's University (Canada)
University/education
University/education
Office of Research Services
Fleming Hall/Jemmett Wing, 3rd floor
78 Fifth Field Company Lane
Kingston, Ontario
K7L 3N6
Canada
| Phone | +1 613 533 6081 |
|---|---|
| woods@queensu.ca | |
| Website | http://www.queensu.ca/ors/contact.html |
"ROR" |
https://ror.org/02y72wh86 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-190617)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/01/2013 | Yes | No | |
| Results article | results | 03/03/2015 | Yes | No |
Editorial Notes
28/03/2019: Publication references added.
