Type 2 DiabetesDARE-BandsNCT02009995
The Diabetes Aerobic and Resistance Bands Exercise (DARE-Bands) Trial
A study testing Aerobic Training (AT) and AT plus Primarily Home-Based Resistance Band Training in people with Type 2 Diabetes, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Aerobic Training (AT) and AT plus Primarily Home-Based Resistance Band Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
- Uncontrolled hypertension: systolic BP >160 mmHg or diastolic BP >100 mmHg, both measured in sitting position. If too-high A1C or BP is the only reason for exclusion, subjects will be asked to see their physicians regarding the hyperglycemia or BP, and invited to re-apply for the study several months later if the problem is under better control.
- Hypo-glycemia unawareness, or severe hypoglycemia requiring assistance from another person within the previous 3 months.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Richmond Road Diagnostic and Treatment Centre
Calgary, Alberta, T2T 5C7
Samantha McGinley, BSc, MSc, 403-955-8117, skmcginl@ucalgary.ca
Ronald Sigal, MPH, MD
About this study
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.
Read more
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.
Read the detailed description
BACKGROUND Resistance exercise training with free weights or weight machines clearly improves glycemic control in type 2 diabetes (T2D). However, many patients with T2D would prefer not to, or are not able to attend an exercise facility,for reasons of cost, comfort or convenience. Coinvestigator Dr. Jonathon Fowles developed a home-based exercise program for people with T2D using resistance bands. Before-after studies using this intervention have found improvements in glycemic control, strength, and blood pressure. However, the effects of resistance-bands training (RBT) on glycemic control in T2D have not been evaluated in a high-quality randomized trial.
RESEARCH QUESTIONS To determine the effects of six months of progressive home-based RBT plus aerobic exercise, versus home-based aerobic exercise alone, in previously-sedentary people with T2D.
METHODS After a 2-week run-in period to assess adherence, 100 T2D subjects not currently engaging in regular exercise will be randomized in equal numbers to 2 arms: primarily home-based RBT (RBT-H) or aerobic only control (ATO) . Both groups will complete aerobic training: accumulation of 150 minutes per week of walking or jogging, measured by accelerometers. The RBT workout will include 12 distinctive exercises, targeting all major muscle groups. Subjects will be trained in groups led by a Kinesiologist (exercise specialist) twice per week for two weeks during run-in. After randomization, the RBT-H group will perform RBT three times per week. RBT-H participants will perform RBT three times per week primarily at home, with 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. Adherence to RBT will be verified through direct supervision of group sessions, and completion of detailed exercise logs for home-based and group sessions. Participants will photograph the log after each session and email the photo to a designated email address. Study outcomes will be assessed at baseline, 12 and 24 weeks post-randomization. Dietary advice will be standardized through repeated sessions with a dietician, and doses of medications altering glucose, lipids and BP will be held constant unless change is medically urgent. Primary analyses will be intention-to-treat, using repeated measures mixed modeling. Per-protocol analyses will be done including only subjects who completed >70% of prescribed exercise sessions and all end-of-study outcome measures.
SIGNIFICANCE The global burden of type 2 diabetes is increasing, and complications of the illness occur primarily in those whose glycemic control is fair or poor. If home-based exercise training with resistance bands improves glycemic control and other vascular risk factors, it could be beneficial to the large numbers of patients who prefer not to have to 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
- Being tested
- Aerobic Training (AT), AT plus Primarily Home-Based Resistance Band Training
- Keywords
- Diabetes Mellitus, Type 2 Diabetes Mellitus, Resistance Training, Resistance Exercise, Resistance Band, Thera-band, elastic band, exercise band
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Training (AT)Behavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Aerobic Training (AT); Behavioral: AT plus Primarily Home-Based Resistance Band Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 12 weeks, 24 weeks
Secondary outcomes (18)
Blood Pressure
Three measures of systolic and diastolic blood pressure (BP) will be taken at 2-minute intervals using a BP-Tru automated BP monitor (BP-Tru, Coquitlam, BC), with the subject sitting with back supported; the mean of the lower two measures will be taken as the true BP.
Measured: Baseline, 12 weeks, 24 weeks
Smoking
will be assessed by self-report (number of cigarettes/day). The smoking rate is expected to be low and we do not expect intergroup differences. We will gather this information because smoking, an important predictor of diabetic complications including CVD, is used in the UKPDS Outcomes Model.
Measured: baseline
Traditional lipids
Total cholesterol, HDL-Cholesterol and triglycerides will be measured by enzymatic colorimetric assays, and LDL-C calculated using the Friedewald equations. Total cholesterol/HDL-cholesterol ratio will be calculated.
Measured: Baseline, 12 weeks, 24 weeks
Apolipoproteins
Apolipoprotein B (ApoB), Apolipoprotein A-1 (ApoA1), ApoB/ApoA1 ratio.
Measured: Baseline, 12 weeks, 24 weeks
HSCRP
Addition of HSCRP (High-sensitivity C-reactive Protein) levels to cardiac risk prediction equations can provide incremental risk discrimination beyond that provided by age, sex, smoking, BP, and diabetes.
Measured: Baseline, 12 weeks, 24 weeks
Moderate-vigourous aerobic exercise
Weekly time spent in moderate-to-vigourous intensity physical activity (i.e. greater than 3 METs) as measured by the MyWellness Key accelerometer will be collected via the web-based interface.
Measured: every week from baseline to 24 weeks
The UKPDS Outcomes Model
is a computer simulation model for forecasting the occurrence of seven diabetes-related complications.
Measured: Baseline, 12 weeks, 24 weeks
Satisfaction with the exercise program
Structured interview.
Measured: 12 and 24 weeks
Continued participation in exercise after end of intervention
telephone interviews every 3 months for 2 years after the end of the intervention period.
Measured: 3, 6, 9, 12, 15, 18, 21, 24 months after completion of the intervention
Medication Changes
Medication and doses will be assessed. Changes (start/increased dose; stop/decreased dose) in medications altering glucose, lipids or blood pressure will be considered secondary outcomes.
Measured: Baseline, 12 weeks, 24 weeks
Adverse Events
Participants will be questioned regularly at each clinic visit regarding adverse events, which will be tracked systematically using standard forms.
Measured: Baseline, 12 weeks, 24 weeks
Hemoglobin A1c (A1C)
A1C reflects average blood glucose over the previous 2-3 months and is expressed as a percent (normal A1C 4-6%, target A1C in diabetes <7%). A 1% absolute decrement in A1C (e.g. from 8.0% to 7.0%) is associated with a 37% lower risk of microvascular complications of diabetes. In epidemiological analyses, lower A1C was also associated with lower risk of CVD. There has never been a negative impact of A1C-lowering in exercise trials.
Measured: Baseline, 12 weeks, 24 weeks
Weight
Taken in light clothing without shoes.
Measured: Baseline, 12 weeks, 24 weeks
Waist circumference
Measured midway between the lowest rib and the top of the iliac crest.
Measured: Baseline, 12 weeks, 24 weeks
Hip circumference
Measured around the widest portion of the buttocks.
Measured: Baseline, 12 weeks, 24 weeks
SF-36 questionnaire
Used to assess health related quality of life.
Measured: Baseline, 12 weeks, 24 weeks
Diabetes Distress Scale Questionnaire
Assesses emotional distress and functioning specific to living with diabetes.
Measured: Baseline, 12 weeks, 24 weeks
EuroQOL EQ-5D questionnaire
Assesses five core domains of quality of life (mobility, self-care, ability to conduct usual activities, pain and discomfort, and anxiety and depression).
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ron Sigal, University of Calgary
- Investigators
- Ronald Sigal, MPH, MD, Principal investigator, University of Calgary, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009995
- Sponsor's protocol ID
- 1026315
- Acronym
- DARE-Bands
- Status last verified
- Oct 2016
- First submitted
- 9 Dec 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diabetes Aerobic and Resistance Bands Exercise (DARE-Bands) Trial
- ClinicalTrials.gov ID
- NCT02009995
- Acronym / sponsor ID
- DARE-Bands / 1026315
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Mellitus, Type 2 Diabetes Mellitus, Resistance Training, Resistance Exercise, Resistance Band, Thera-band, elastic band, exercise band
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND Resistance exercise training with free weights or weight machines clearly improves glycemic control in type 2 diabetes (T2D). However, many patients with T2D would prefer not to, or are not able to attend an exercise facility,for reasons of cost, comfort or convenience. Coinvestigator Dr. Jonathon Fowles developed a home-based exercise program for people with T2D using resistance bands. Before-after studies using this intervention have found improvements in glycemic control, strength, and blood pressure. However, the effects of resistance-bands training (RBT) on glycemic control in T2D have not been evaluated in a high-quality randomized trial.
RESEARCH QUESTIONS To determine the effects of six months of progressive home-based RBT plus aerobic exercise, versus home-based aerobic exercise alone, in previously-sedentary people with T2D.
METHODS After a 2-week run-in period to assess adherence, 100 T2D subjects not currently engaging in regular exercise will be randomized in equal numbers to 2 arms: primarily home-based RBT (RBT-H) or aerobic only control (ATO) . Both groups will complete aerobic training: accumulation of 150 minutes per week of walking or jogging, measured by accelerometers. The RBT workout will include 12 distinctive exercises, targeting all major muscle groups. Subjects will be trained in groups led by a Kinesiologist (exercise specialist) twice per week for two weeks during run-in. After randomization, the RBT-H group will perform RBT three times per week. RBT-H participants will perform RBT three times per week primarily at home, with 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. Adherence to RBT will be verified through direct supervision of group sessions, and completion of detailed exercise logs for home-based and group sessions. Participants will photograph the log after each session and email the photo to a designated email address. Study outcomes will be assessed at baseline, 12 and 24 weeks post-randomization. Dietary advice will be standardized through repeated sessions with a dietician, and doses of medications altering glucose, lipids and BP will be held constant unless change is medically urgent. Primary analyses will be intention-to-treat, using repeated measures mixed modeling. Per-protocol analyses will be done including only subjects who completed >70% of prescribed exercise sessions and all end-of-study outcome measures.
SIGNIFICANCE The global burden of type 2 diabetes is increasing, and complications of the illness occur primarily in those whose glycemic control is fair or poor. If home-based exercise training with resistance bands improves glycemic control and other vascular risk factors, it could be beneficial to the large numbers of patients who prefer not to have to 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training (AT) only | Active comparator | Behavioral: Aerobic Training (AT)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 | Experimental | Behavioral: Aerobic Training (AT), Behavioral: AT plus Primarily Home-Based Resistance Band TrainingBoth 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
- Uncontrolled hypertension: systolic BP >160 mmHg or diastolic BP >100 mmHg, both measured in sitting position. If too-high A1C or BP is the only reason for exclusion, subjects will be asked to see their physicians regarding the hyperglycemia or BP, and invited to re-apply for the study several months later if the problem is under better control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Training (AT)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. | Behavioural | AT plus Primarily Home-Based Resistance Band Training, Aerobic Training (AT) only |
| AT plus Primarily Home-Based Resistance Band TrainingThe 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. | Behavioural | AT plus Primarily Home-Based Resistance Band Training |
Primary outcome
Testing of Strength
Time frame: Baseline, 12 weeks, 24 weeks
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).
18 secondary outcomes
Blood Pressure
Time frame: Baseline, 12 weeks, 24 weeks
Smoking
Time frame: baseline
Traditional lipids
Time frame: Baseline, 12 weeks, 24 weeks
Apolipoproteins
Time frame: Baseline, 12 weeks, 24 weeks
HSCRP
Time frame: Baseline, 12 weeks, 24 weeks
Moderate-vigourous aerobic exercise
Time frame: every week from baseline to 24 weeks
The UKPDS Outcomes Model
Time frame: Baseline, 12 weeks, 24 weeks
Satisfaction with the exercise program
Time frame: 12 and 24 weeks
Continued participation in exercise after end of intervention
Time frame: 3, 6, 9, 12, 15, 18, 21, 24 months after completion of the intervention
Medication Changes
Time frame: Baseline, 12 weeks, 24 weeks
Adverse Events
Time frame: Baseline, 12 weeks, 24 weeks
Hemoglobin A1c (A1C)
Time frame: Baseline, 12 weeks, 24 weeks
Weight
Time frame: Baseline, 12 weeks, 24 weeks
Waist circumference
Time frame: Baseline, 12 weeks, 24 weeks
Hip circumference
Time frame: Baseline, 12 weeks, 24 weeks
SF-36 questionnaire
Time frame: Baseline, 12 weeks, 24 weeks
Diabetes Distress Scale Questionnaire
Time frame: Baseline, 12 weeks, 24 weeks
EuroQOL EQ-5D questionnaire
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Sigal, MPH, MD principal investigator
University of Calgary, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Training (AT) and AT plus Primarily Home-Based Resistance Band Training in people with Type 2 Diabetes, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing of Strength (time frame: Baseline, 12 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.