Contact information
Type
Scientific
Primary contact
Prof Robert Ross
ORCID ID
Contact details
Queen's University
School of Kinesiology and Health Studies
28 Division Street
Kingston
K7L 3N6
Canada
-
rossr@queensu.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00955071
Protocol/serial number
MCT-190617
Study information
Scientific title
Dose-response effects of exercise on abdominal obesity and risk factors for cardiovascular disease (CVD) in women and men
Acronym
SERENA
Study hypothesis
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
Queens University, Faculty of Health Sciences Research Ethics Board (REB) approved on the 22nd July 2009 (ref: PHE-093-09)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/09/2009
Overall trial end date
31/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
320
Participant 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
Recruitment start date
01/09/2009
Recruitment end date
31/08/2013
Locations
Countries of recruitment
Canada
Trial participating centre
Queen's University
Kingston
K7L 3N6
Canada
Sponsor information
Organisation
Queen's University (Canada)
Sponsor details
Office of Research Services
Fleming Hall/Jemmett Wing
3rd floor
78 Fifth Field Company Lane
Kingston
Ontario
K7L 3N6
Canada
+1 613 533 6081
woods@queensu.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-190617)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/23123790
2. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25732273