Diabetes Aerobic and Resistance Exercise (DARE) Study
Resistance Exercise as an Intervention in Type 2 Diabetes Mellitus
1 other identifier
interventional
251
1 country
1
Brief Summary
The main purpose of this study is to assess the impact of exercise training (aerobic exercise, resistance exercise, combined aerobic and resistance exercise) versus a sedentary waiting list control on glycemic control (as reflected in reduced hemoglobin A1c \[HbA1c\]), body composition (weight, body mass index \[BMI\], waist circumference, total body fat, visceral and subcutaneous abdominal fat, mid-thigh muscle cross-sectional area), lipids (Apo-B, Apo-A1, Apo-B/A1 ratio, low density lipoprotein (LDL) particle diameter, high-sensitivity C-reactive protein) and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Sep 1999
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJanuary 23, 2013
January 1, 2013
5.5 years
September 12, 2005
January 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hemoglobin A1c (HbA1c)
Measured pre and post intervention
6-months
Secondary Outcomes (5)
Body composition (CT scan)
6-months
resting energy expenditure
6-months
LDL particle diameter, insulin, CRP, FFA, HDL, LDL, Total chol./HDL ratio, triglycerides
6-months
Blood Pressure
6-months
quality of life (QOL)
6-months
Study Arms (4)
Aerobic Group
EXPERIMENTALAerobic training is divided into three stages: the Starter phase (during the run-in period), the Progression phase, and the Maintenance phase. All aerobic activities are performed on a cycle ergometer, treadmill, elliptical exercise machine or stairclimber. Subjects are free to vary the machine(s) used from one visit to the next. Exercise intensity is standardized using Polar Heartminder heart rate monitors that display the subject's heart rate and emits a warming signal when heart rate is outside the prescribed training zone, thus guiding the subject in adjustment of the work load up or down to achieve the desired intensity.
Resistance Group
EXPERIMENTALExercises are performed at weight machines arranged in a circuit. Throughout the resistance training program, subjects will alternate between the exercises of group A and group B below. * Group A: abdominal crunches, seated row (back), seated biceps curls, supine bench press (chest), leg press, shoulder press (shoulders and neck); leg extension (quadriceps) * Group B: abdominal crunches, lat pulldown (back), sitting chest press (chest), leg press, upright row (shoulders and neck), triceps pushdown, leg curls (hamstrings). Subjects are instructed to exhale while lifting a weight and inhale while lowering it, in order to minimize blood pressure excursions. Warm-up and cooldown are the same as for aerobic training.
Combined Aerobic and Resistance Training
EXPERIMENTALCombined aerobic and resistance training. This group will perform both aerobic and resistance training programs, as described above. The aerobic and resistance components are performed on the same days, in varying orders.
Control Group
NO INTERVENTIONMembers of this group are asked to revert to their pre-study activity levels for 5 months, at which point they begin the combined aerobic and resistance exercise program.
Interventions
Aerobic activities are performed on a cycle ergometer or treadmill. Exercise intensity is standardized using Polar Heart rate monitors that display the subject's heart rate. Resistance training:Exercises are performed at weight machines arranged in a circuit. Throughout the resistance training program, subjects will alternate between the exercises of group A and group B below. Group A: abdominal crunches, seated row, seated biceps curls, supine bench press, leg press, shoulder press; leg extension Group B: abdominal crunches, lat pulldown, sitting chest press, leg press, upright row, triceps pushdown, leg curls. Combined aerobic and resistance training group will perform both aerobic and resistance training programs, as described above. Control: members of this group are asked to revert to their pre-study activity levels for 5 months, at which point they begin the combined aerobic and resistance exercise program.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus as defined by the 1998 CDA Guidelines
- Male or female
- treated with diet and/or oral agents (no insulin)
- age 40-70
- HbA1c 0.066-0.099
You may not qualify if:
- Participation during the previous 6 months in a regular program of exercise or aerobic sports greater than 2 times per week for at least 20 minutes per session, or in any resistance training during the previous 6 months
- Changes in medications for diabetes, BP or lipids in the 2 months prior to enrollment.
- Significant weight change (increase or decrease of greater than 5% of body weight during the two months before enrollment).
- Significant renal disease: serum creatinine greater than 200 mEq/l. or proteinuria \>1 g/24 hours.
- Uncontrolled hypertension: BP \>160 mm Hg systolic or \>95 mm Hg diastolic BP in a sitting position.
- Restrictions in physical activity due to disease: intermittent claudication, severe peripheral neuropathy or active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis.
- Other illness, judged by the patient or study physician to make participation in this study inadvisable.
- Significant cognitive deficit resulting in inability to understand or comply with instructions.
- Pregnancy at the start of the study, or intention to become pregnant in the next year.
- Inability to communicate in English or French.
- Unwillingness to sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- Canadian Institutes of Health Research (CIHR)collaborator
- University of Ottawacollaborator
- Canadian Diabetes Associationcollaborator
Study Sites (1)
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 7W9, Canada
Related Publications (6)
Sigal RJ, Kenny GP, Wasserman DH, Castaneda-Sceppa C. Physical activity/exercise and type 2 diabetes. Diabetes Care. 2004 Oct;27(10):2518-39. doi: 10.2337/diacare.27.10.2518. No abstract available.
PMID: 15451933BACKGROUNDBoule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.
PMID: 11559268BACKGROUNDTerada T, Boule NG, Forhan M, Prado CM, Kenny GP, Prud'homme D, Ito E, Sigal RJ. Cardiometabolic risk factors in type 2 diabetes with high fat and low muscle mass: At baseline and in response to exercise. Obesity (Silver Spring). 2017 May;25(5):881-891. doi: 10.1002/oby.21808. Epub 2017 Mar 20.
PMID: 28317297DERIVEDGavin C, Sigal RJ, Cousins M, Menard ML, Atkinson M, Khandwala F, Kenny GP, Proctor S, Ooi TC; Diabetes Aerobic and Resistance Exercise (DARE) trial investigators. Resistance exercise but not aerobic exercise lowers remnant-like lipoprotein particle cholesterol in type 2 diabetes: a randomized controlled trial. Atherosclerosis. 2010 Dec;213(2):552-7. doi: 10.1016/j.atherosclerosis.2010.08.071. Epub 2010 Sep 27.
PMID: 20870234DERIVEDReid RD, Tulloch HE, Sigal RJ, Kenny GP, Fortier M, McDonnell L, Wells GA, Boule NG, Phillips P, Coyle D. Effects of aerobic exercise, resistance exercise or both, on patient-reported health status and well-being in type 2 diabetes mellitus: a randomised trial. Diabetologia. 2010 Apr;53(4):632-40. doi: 10.1007/s00125-009-1631-1. Epub 2009 Dec 13.
PMID: 20012857DERIVEDSigal RJ, Kenny GP, Boule NG, Wells GA, Prud'homme D, Fortier M, Reid RD, Tulloch H, Coyle D, Phillips P, Jennings A, Jaffey J. Effects of aerobic training, resistance training, or both on glycemic control in type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Sep 18;147(6):357-69. doi: 10.7326/0003-4819-147-6-200709180-00005.
PMID: 17876019DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald J Sigal, MD MPH FRCPC
Ottawa Hospital Research Institute, Ottawa Hospital, University of Ottawa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
September 1, 1999
Primary Completion
March 1, 2005
Study Completion
April 1, 2011
Last Updated
January 23, 2013
Record last verified: 2013-01