Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/02/2010
Date assigned
11/02/2010
Last edited
11/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Queen’s 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 measures

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

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

http://www.queensu.ca/ors/contact.html

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes