Diabetes Aerobic and Resistance Exercise (DARE) Study

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Ottawa
Canadian Diabetes Association
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00195884
First received: September 12, 2005
Last updated: January 22, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • hemoglobin A1c (HbA1c) [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Measured pre and post intervention


Secondary Outcome Measures:
  • 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.

  • 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.

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195884

Locations
Canada, Ontario
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 7W9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
University of Ottawa
Canadian Diabetes Association
Investigators
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 August 21, 2014