Effects of different intensities of exercise on health risk factors

ISRCTN ISRCTN43414825
DOI https://doi.org/10.1186/ISRCTN43414825
ClinicalTrials.gov (NCT) NCT00955071
Protocol serial number MCT-190617
Sponsor Queen's University (Canada)
Funder Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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

Queen's University
School of Kinesiology and Health Studies
28 Division Street
Kingston
K7L 3N6
Canada

rossr@queensu.ca

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleDose-response effects of exercise on abdominal obesity and risk factors for cardiovascular disease (CVD) in women and men
Study acronymSERENA
Study objectivesThe 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)Queen’s 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) studiedCardiometabolic risk
InterventionThe 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 typeOther
Primary outcome measure(s)

Waist circumference and 2-hour glucose, measured at baseline, 16, 24 and 48 weeks

Key secondary outcome measure(s)

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)

Completion date31/08/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration320
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2009
Date of final enrolment31/08/2013

Locations

Countries of recruitment

  • Canada

Study participating centre

Queen's University
Kingston
K7L 3N6
Canada

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 03/03/2015 Yes No
Protocol article protocol 01/01/2013 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

28/03/2019: Publication references added.

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