Health Benefits of Aerobic and Resistance Training in Individuals With Type 2 Diabetes

NCT ID: NCT00458133

Last Updated: 2022-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-06-30

Brief Summary

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The goal of the proposed study, Health Benefits of Aerobic and Resistance Training in individuals with type 2 diabetes (HART-D), is to compare the effect of resistance training alone (RT), resistance in combination with aerobic training (AT+RT), and aerobic training alone (AT) to standard care (SC) on hemoglobin A1C (HbA1C), in initially sedentary women and men with type 2 diabetes (T2D).

Detailed Description

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Although it is generally accepted that regular exercise provides substantial health benefits to individuals with T2D, the exact exercise prescription in terms of type (AT versus RT versus AT+RT) still remains an important research issue, particularly in regard to week-to-week glucose control as assessed by HbA1C.

There is a need for more adequately powered and well-controlled studies to examine the effects of RT, AT and AT+RT on HbA1C in individuals with T2D. With the incidence of T2D expected to increase dramatically in the coming years, it is essential to have a better understanding of the relative benefits of various exercise interventions. This information can help better formulate exercise recommendations for patients with T2D as well as potentially provide more exercise options, which is important given the small percentage of individuals with TD2 who regularly exercise. The study group was sedentary women and men with T2D, aged 30 to 75 years. We randomly assigned 262 individuals to an aerobic exercise training only group (AT; n=72), a resistance training only group (RT; n=73), a combination of aerobic plus resistance training (AT+RT; n=76), or a standard care group (SC; n=41). The AT individuals participated in 3 or 4 training sessions each week for 9 months progressing to a total energy expenditure of 12 kcal/kg/week (KKW), which is an exercise dose consistent with the current public health recommendations for physical activity for individuals with T2D. The target exercise intensity was 50%-80% of baseline VO2 max. The RT group participated in 3 sessions per week (9 exercises, 2-3 sets each), which focuses on large muscle groups. This RT regimen is based on the studies that most successfully improved HbA1C in individuals with T2D. Individuals in the AT+RT group completed 10 KKW of aerobic training and a reduced resistance-training regimen of 2 sessions per week (9 exercises, 1 set of each). The AT+RT regimen represents the exercise recommendations of the American College of Sports Medicine (ACSM) and the American Diabetes Association (ADA).

Simply stated, we compared the effect of resistance training alone, resistance in combination with aerobic training, and aerobic training alone to standard care on HbA1C, in initially sedentary women and men with T2D. The primary outcome measure was HbA1C, an integrated measure of blood glucose control over the past 8-12 weeks. Other outcomes of interest included resting blood pressure, C-reactive protein (CRP), total body fat, and lean muscle mass as measured by DEXA, cardiorespiratory fitness, muscular strength, and metabolic measures including serum cholesterol and triglycerides.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

We randomly assigned 72 individuals to an aerobic exercise training only group.

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching \& relaxing groups.

2

We randomly assigned 73 individuals to an resistance exercise training only group.

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching \& relaxing groups.

3

We randomly assigned 76 individuals to a combination of aerobic plus resistance training group.

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching \& relaxing groups.

4

We randomly assigned 41 individuals to a stretching and relaxation group.

Group Type PLACEBO_COMPARATOR

exercise

Intervention Type BEHAVIORAL

compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching \& relaxing groups.

Interventions

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exercise

compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching \& relaxing groups.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 30-75 years
* type 2 diabetes determined by self-report with verification
* 6.5% \< HbA1C \< 11%
* sedentary lifestyle - not being physically active greater than or equal to 3 days per week for 20 minutes each time for the previous 6 months, and not performing regular resistance exercise

Exclusion Criteria

* inadequate control of co-morbid conditions
* resting blood pressure greater than or equal to 160/100 mm Hg
* Triglycerides greater than or equal to 500 mg/dL
* BMI is greater than or equal to 48
* current use of an insulin pump or insulin injections other than Lantus
* metal object in the body that may interfere with MRI/MRS scans
* factors that may limit adherence to intervention or affect conduct of the trial

1. unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment
2. failure to complete behavioral run-in and baseline testing
3. hospitalization for depression in the last 6 months
4. not physically capable of performing the exercise required for the study protocols
5. consuming \> 14 alcoholic beverages per week
6. plans to be away \> 4 weeks in the next 9 months
7. lack of support from primary health care provider or family members
8. significant weight loss in the past year (\>20 lbs) or current use of weight loss medications
9. current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
10. another member of household is a participant or staff member of HART-D
11. bariatric surgery
12. other temporary intervening event, such as sick spouse, bereavement, or recent move
13. other medical, psychiatric, or behavioral limitations that, in the view of the principal investigator, may interfere with study participation or the ability to follow the intervention protocol
* underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention

1. pregnant or plan on becoming pregnant in the next 9 months
2. cancers requiring treatment in the past 5 years, unless prognosis is excellent
3. self-reported HIV or tuberculosis
4. history or evidence of serious arrythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation
5. renal disease: urine dipstick 4+ protein, serum creatinine is greater than or equal to 1.4 mg/dL (women) or is greater than or equal to 1.5 mg/dL (men) or currently receiving dialysis
6. any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise
7. advanced neuropathy or retinopathy
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy S Church, MPH, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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Church TS, Blair SN, Cocreham S, Johannsen N, Johnson W, Kramer K, Mikus CR, Myers V, Nauta M, Rodarte RQ, Sparks L, Thompson A, Earnest CP. Effects of aerobic and resistance training on hemoglobin A1c levels in patients with type 2 diabetes: a randomized controlled trial. JAMA. 2010 Nov 24;304(20):2253-62. doi: 10.1001/jama.2010.1710.

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Swift DL, Johannsen NM, Earnest CP, Blair SN, Church TS. Effect of exercise training modality on C-reactive protein in type 2 diabetes. Med Sci Sports Exerc. 2012 Jun;44(6):1028-34. doi: 10.1249/MSS.0b013e31824526cc.

Reference Type RESULT
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Swift DL, Johannsen NM, Myers VH, Earnest CP, Smits JA, Blair SN, Church TS. The effect of exercise training modality on serum brain derived neurotrophic factor levels in individuals with type 2 diabetes. PLoS One. 2012;7(8):e42785. doi: 10.1371/journal.pone.0042785. Epub 2012 Aug 6.

Reference Type RESULT
PMID: 22880108 (View on PubMed)

Senechal M, Johannsen NM, Swift DL, Earnest CP, Lavie CJ, Blair SN, Church TS. Association between Changes in Muscle Quality with Exercise Training and Changes in Cardiorespiratory Fitness Measures in Individuals with Type 2 Diabetes Mellitus: Results from the HART-D Study. PLoS One. 2015 Aug 7;10(8):e0135057. doi: 10.1371/journal.pone.0135057. eCollection 2015.

Reference Type DERIVED
PMID: 26252477 (View on PubMed)

Pandey A, Swift DL, McGuire DK, Ayers CR, Neeland IJ, Blair SN, Johannsen N, Earnest CP, Berry JD, Church TS. Metabolic Effects of Exercise Training Among Fitness-Nonresponsive Patients With Type 2 Diabetes: The HART-D Study. Diabetes Care. 2015 Aug;38(8):1494-501. doi: 10.2337/dc14-2378. Epub 2015 Jun 17.

Reference Type DERIVED
PMID: 26084342 (View on PubMed)

Henagan TM, Stewart LK, Forney LA, Sparks LM, Johannsen N, Church TS. PGC1alpha -1 Nucleosome Position and Splice Variant Expression and Cardiovascular Disease Risk in Overweight and Obese Individuals. PPAR Res. 2014;2014:895734. doi: 10.1155/2014/895734. Epub 2014 Dec 28.

Reference Type DERIVED
PMID: 25614734 (View on PubMed)

Johannsen NM, Swift DL, Lavie CJ, Earnest CP, Blair SN, Church TS. Categorical analysis of the impact of aerobic and resistance exercise training, alone and in combination, on cardiorespiratory fitness levels in patients with type 2 diabetes: results from the HART-D study. Diabetes Care. 2013 Oct;36(10):3305-12. doi: 10.2337/dc12-2194. Epub 2013 Jul 22.

Reference Type DERIVED
PMID: 23877979 (View on PubMed)

Johannsen NM, Sparks LM, Zhang Z, Earnest CP, Smith SR, Church TS, Ravussin E. Determinants of the Changes in Glycemic Control with Exercise Training in Type 2 Diabetes: A Randomized Trial. PLoS One. 2013 Jun 21;8(6):e62973. doi: 10.1371/journal.pone.0062973. Print 2013.

Reference Type DERIVED
PMID: 23805175 (View on PubMed)

Senechal M, Swift DL, Johannsen NM, Blair SN, Earnest CP, Lavie CJ, Church TS. Changes in body fat distribution and fitness are associated with changes in hemoglobin A1c after 9 months of exercise training: results from the HART-D study. Diabetes Care. 2013 Sep;36(9):2843-9. doi: 10.2337/dc12-2428. Epub 2013 May 13.

Reference Type DERIVED
PMID: 23670995 (View on PubMed)

Other Identifiers

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R01DK068298

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBRC 26046

Identifier Type: -

Identifier Source: org_study_id

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