The Diabetes Aerobic and Resistance Bands Exercise (DARE-Bands) Trial

NCT02009995 | Unknown

• 1 other identifier: 1026315
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND Resistance exercise training with free weights or weight machines clearly improves glucose (sugar) control in type 2 diabetes (T2D). However, many patients with T2D would prefer not to attend an exercise facility, for reasons of cost and/or convenience. Coinvestigator Jonathon Fowles has developed and pilot-tested a home-based exercise program for people with T2D using resistance bands. However, the effects of resistance-bands training (on glucose control in T2D have not been evaluated in a high-quality randomized trial. SPECIFIC AIMS To determine the effects of six months of progressive home-based resistance bands training (RBT) versus no RBT in people with T2D on blood glucose control (HbA1c, primary outcome), waist circumference, heart disease risk factors, and quality of life. METHODS A total of 100 T2D participants will be randomized to 2 arms: home-based RBT (RBT-H) or aerobic training only (ATO). Both groups will accumulate 150 minutes per week of aerobic exercise such as walking. The resistance exercise workout includes 12 exercises, targeting all major muscle groups. RBT-H subjects will complete most exercise at home with periodic supervision. SIGNIFICANCE The global burden of type 2 diabetes is increasing, and complications of the illness occur primarily in those whose glucose control is fair or poor. If exercise training with resistance bands improves glucose control, it could be beneficial to the large numbers of patients who cannot travel to a gym or cannot afford gym membership. If resistance exercise is then adopted by more patients, it is likely that the morbidity associated with type 2 diabetes will be decreased. This is particularly true if such training also improves quality of life, and more people are thus inclined to continue exercising in the long term.

Conditions

Type 2 Diabetes

Keywords

Diabetes Mellitus; Type 2 Diabetes Mellitus; Resistance Training; Resistance Exercise; Resistance Band; Thera-band; elastic band; exercise band

Outcome Measures

Primary Outcomes (1)

• Testing of Strength

  The maximum weight that can be lifted 8 times while maintaining proper form (8RM) will be determined for chest press (upper body) and leg press (lower body).

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (18)

• Blood Pressure

  Baseline, 12 weeks, 24 weeks

• Smoking

  baseline

• Traditional lipids

  Baseline, 12 weeks, 24 weeks

• Apolipoproteins

  Baseline, 12 weeks, 24 weeks

• HSCRP

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

Aerobic Training (AT) only

ACTIVE COMPARATOR

All subjects will participate in a 10-week ramp-in period with the goal of achieving 150 minutes of moderate-to-vigorous physical activity per week. Walking and jogging will be the primary modes of achieving the prescribed aerobic activity as these are the modes of aerobic exercise that are most accurately recorded by an accelerometer. Subjects will use the Rate of Perceived Exertion (RPE) to guide aerobic exercise intensity. Aerobic activity will be objectively monitored by the Technogym MyWellness Key (MWK) accelerometer, which is a lightweight device worn on the waistband.

Behavioral: Aerobic Training (AT)

AT plus Primarily Home-Based Resistance Band Training

EXPERIMENTAL

Both of the bands + AT groups will engage in RBT 3 times per week, progressing to 3 sets of 8-12 repetitions of 12 exercises. The exercises will be: chair squat, sitting chest press, seated rear fly, seated row, overhead press, lateral raise, biceps curl, triceps extension, leg extension, hamstring curl, gluteal extension, and abdominals. The resistance band exercise sessions will be between 25-60 minutes. Participants in this group will attend supervised group sessions weekly in weeks 1-4, every 2 weeks in weeks 5-8, and every 4 weeks thereafter to ensure proper form and appropriate progression. Participants in this group will be responsible to complete all remaining sessions (a total of 3 per week, including supervised sessions) at home on their own time.

Behavioral: Aerobic Training (AT); Behavioral: AT plus Primarily Home-Based Resistance Band Training

Interventions

Aerobic Training (AT) BEHAVIORAL

All subjects will participate in a 10-week ramp-in period with the goal of achieving 150 minutes of moderate-to-vigorous physical activity per week. Walking and jogging will be the primary modes of achieving the prescribed aerobic activity as these are the modes of aerobic exercise that are most accurately recorded by an accelerometer. Subjects will use the Rate of Perceived Exertion (RPE) to guide aerobic exercise intensity. Aerobic activity will be objectively monitored by the Technogym MyWellness Key (MWK) accelerometer, which is a lightweight device worn on the waistband.

AT plus Primarily Home-Based Resistance Band Training; Aerobic Training (AT) only

AT plus Primarily Home-Based Resistance Band Training BEHAVIORAL

The bands + AT group will engage in RBT 3 times per week, progressing to 3 sets of 10-15 repetitions of 12 exercises. The exercises will be: chair squat, sitting chest press, seated rear fly, seated row, overhead press, lateral raise, biceps curl, triceps extension, leg extension, hamstring curl, gluteal extension, and abdominals. The resistance band exercise sessions will be between 25-60 minutes. Participants in this group will attend supervised group sessions weekly in weeks 1-4, every 2 weeks in weeks 5-8, and every 4 weeks thereafter to ensure proper form and appropriate progression. Participants in this group will be responsible to complete all remaining sessions (a total of 3 per week, including supervised sessions) at home on their own time.

AT plus Primarily Home-Based Resistance Band Training

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged \>35 years with T2D as defined by the CDA Expert Committee.
• A1C values within range of 6.6%-9.9%.
• Willingness to follow study procedures (e.g. wear the accelerometer for exercise sessions and download them at least weekly, complete exercise logs, attend supervised group-based resistance band sessions, perform resistance bands exercise at home).

You may not qualify if:

• Participation in a regular program of physical conditioning or aerobic sports/activities for \>150 minutes per week during the 6 months prior to enrolment.
• Participation in any resistance exercise training during the previous 6 months.
• Requirement for insulin therapy currently or in the previous 3 months.
• Uncontrolled hyperglycemia (A1C \> 10%), as it would be a clear indication for cointervention.
• Hypo-glycemia unawareness, or severe hypoglycemia requiring assistance from another person within the previous 3 months.
• Restrictions in physical activity due to disease: unstable cardiac or pulmonary disease, severe aortic stenosis, Marfan's syndrome (risk of aortic dissection from resistance training), intermittent claudication sufficient to interfere with aerobic exercise progression, severe peripheral neuropathy or active proliferative retinopathy, disabling stroke, severe arthritis, musculoskeletal injuries compromising safety of the prescribed exercises, inability to walk 10 minutes.
• Other illness, judged by the patient or study physician to make participation in this study inadvisable.
• Inability to understand or comply with instructions.
• Pregnancy at the start of the study, or intention to become pregnant in the next 6 months.
• Plans to move to a different city within the next 12 months.
• Inability to communicate in English or French.
• Unwillingness to sign informed consent.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Richmond Road Diagnostic and Treatment Centre

Calgary, Alberta, T2T 5C7, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ronald Sigal, MPH, MD

  University of Calgary, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Cardiac Sciences, Kinesiology and Community Health Sciences

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

CA (1)