Diabetes Aerobic and Resistance Exercise (DARE) Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 Diabetes Mellitus |
Behavioral: Aerobic and Resistance Exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Resistance Exercise as an Intervention in Type 2 Diabetes Mellitus |
- hemoglobin A1c (HbA1c) [ Time Frame: 6-months ] [ Designated as safety issue: No ]Measured pre and post intervention
- Body composition (CT scan) [ Time Frame: 6-months ] [ Designated as safety issue: No ]Measured pre and post intervention
- resting energy expenditure [ Time Frame: 6-months ] [ Designated as safety issue: No ]Measured pre and post intervention
- LDL particle diameter, insulin, CRP, FFA, HDL, LDL, Total chol./HDL ratio, triglycerides [ Time Frame: 6-months ] [ Designated as safety issue: No ]Measured pre and post intervention
- Blood Pressure [ Time Frame: 6-months ] [ Designated as safety issue: No ]Measured pre and post intervention
- quality of life (QOL) [ Time Frame: 6-months ] [ Designated as safety issue: No ]Measured pre and post intervention
| Enrollment: | 251 |
| Study Start Date: | September 1999 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aerobic Group
Aerobic 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.
|
Behavioral: Aerobic and Resistance Exercise
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. Other Name: non applicable
|
|
Experimental: Resistance Group
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.
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. |
Behavioral: Aerobic and Resistance Exercise
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. Other Name: non applicable
|
|
Experimental: Combined Aerobic and Resistance Training
Combined 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.
|
Behavioral: Aerobic and Resistance Exercise
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. Other Name: non applicable
|
|
No Intervention: Control Group
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Insulin therapy, or uncontrolled hyperglycemia (HbA1c>0.099). Insulin therapy is an exclusion criterion because it would render HOMA insulin sensitivity calculation invalid.
- 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.
Contacts and Locations| Canada, Ontario | |
| Ottawa Hospital Research Institute | |
| Ottawa, Ontario, Canada, K1H 7W9 | |
| Principal Investigator: | Ronald J Sigal, MD MPH FRCPC | Ottawa Hospital Research Institute, Ottawa Hospital, University of Ottawa |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00195884 History of Changes |
| Other Study ID Numbers: | MCT-44155 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 22, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Ottawa Hospital Research Institute:
|
Diabetes Mellitus Type 2 Diabetes Aerobic |
Resistance weight training Exercise |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013