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Health Benefits of Aerobic and Resistance Training in Individuals With Type 2 Diabetes (HART-D)
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Louisiana
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Baton Rouge, Louisiana, Verenigde Staten, 70817
- Pennington Biomedical Research Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
- unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment
- failure to complete behavioral run-in and baseline testing
- hospitalization for depression in the last 6 months
- not physically capable of performing the exercise required for the study protocols
- consuming > 14 alcoholic beverages per week
- plans to be away > 4 weeks in the next 9 months
- lack of support from primary health care provider or family members
- significant weight loss in the past year (>20 lbs) or current use of weight loss medications
- current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- another member of household is a participant or staff member of HART-D
- bariatric surgery
- other temporary intervening event, such as sick spouse, bereavement, or recent move
- 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
- pregnant or plan on becoming pregnant in the next 9 months
- cancers requiring treatment in the past 5 years, unless prognosis is excellent
- self-reported HIV or tuberculosis
- history or evidence of serious arrythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation
- 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
- any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise
- advanced neuropathy or retinopathy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 1
We randomly assigned 72 individuals to an aerobic exercise training only group.
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compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
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Experimenteel: 2
We randomly assigned 73 individuals to an resistance exercise training only group.
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compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
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Experimenteel: 3
We randomly assigned 76 individuals to a combination of aerobic plus resistance training group.
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compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
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Placebo-vergelijker: 4
We randomly assigned 41 individuals to a stretching and relaxation group.
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compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Hemoglobin A1C
Tijdsspanne: at 9 months
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at 9 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Fasting glucose
Tijdsspanne: at 9 months
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at 9 months
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Basal insulin
Tijdsspanne: at 9 months
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at 9 months
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Resting blood pressure
Tijdsspanne: at 9 months
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at 9 months
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C reactive protein
Tijdsspanne: at 9 months
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at 9 months
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Visceral adiposity
Tijdsspanne: at 9 months
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at 9 months
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Body Composition
Tijdsspanne: at 9 months
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at 9 months
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Cardiorespiratory fitness
Tijdsspanne: at 9 months
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at 9 months
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Muscular strength
Tijdsspanne: at 9 months
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at 9 months
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metabolic measures, including serum cholesterol and triglycerides
Tijdsspanne: at 9 months
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at 9 months
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Timothy S Church, MPH, MD, PhD, Pennington Biomedical Research Center
Publicaties en nuttige links
Algemene publicaties
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- Nelson KM, Reiber G, Boyko EJ; NHANES III. Diet and exercise among adults with type 2 diabetes: findings from the third national health and nutrition examination survey (NHANES III). Diabetes Care. 2002 Oct;25(10):1722-8. doi: 10.2337/diacare.25.10.1722.
- Khaw KT, Wareham N, Luben R, Bingham S, Oakes S, Welch A, Day N. Glycated haemoglobin, diabetes, and mortality in men in Norfolk cohort of european prospective investigation of cancer and nutrition (EPIC-Norfolk). BMJ. 2001 Jan 6;322(7277):15-8. doi: 10.1136/bmj.322.7277.15.
- Ishii T, Yamakita T, Sato T, Tanaka S, Fujii S. Resistance training improves insulin sensitivity in NIDDM subjects without altering maximal oxygen uptake. Diabetes Care. 1998 Aug;21(8):1353-5. doi: 10.2337/diacare.21.8.1353.
- Baldi JC, Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med. 2003 Aug;24(6):419-23. doi: 10.1055/s-2003-41173.
- Katsuki A, Sumida Y, Gabazza EC, Murashima S, Furuta M, Araki-Sasaki R, Hori Y, Yano Y, Adachi Y. Homeostasis model assessment is a reliable indicator of insulin resistance during follow-up of patients with type 2 diabetes. Diabetes Care. 2001 Feb;24(2):362-5. doi: 10.2337/diacare.24.2.362.
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- Smutok MA, Reece C, Kokkinos PF, Farmer CM, Dawson PK, DeVane J, Patterson J, Goldberg AP, Hurley BF. Effects of exercise training modality on glucose tolerance in men with abnormal glucose regulation. Int J Sports Med. 1994 Aug;15(6):283-9. doi: 10.1055/s-2007-1021061.
- Surgeon General's report on physical activity and health. From the Centers for Disease Control and Prevention. JAMA. 1996 Aug 21;276(7):522. No abstract available.
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- Willey KA, Singh MA. Battling insulin resistance in elderly obese people with type 2 diabetes: bring on the heavy weights. Diabetes Care. 2003 May;26(5):1580-8. doi: 10.2337/diacare.26.5.1580.
- 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. Erratum In: JAMA. 2011 Mar 2;305(9):892.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PBRC 26046
- R01DK068298 (Subsidie/contract van de Amerikaanse NIH)
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