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Health Benefits of Aerobic and Resistance Training in Individuals With Type 2 Diabetes (HART-D)

2022年9月13日 更新者:Pennington Biomedical Research Center
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).

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

262

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Louisiana
      • Baton Rouge、Louisiana、アメリカ、70817
        • Pennington Biomedical Research Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

30年~75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:1
We randomly assigned 72 individuals to an aerobic exercise training only group.
compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
実験的:2
We randomly assigned 73 individuals to an resistance exercise training only group.
compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
実験的:3
We randomly assigned 76 individuals to a combination of aerobic plus resistance training group.
compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.
プラセボコンパレーター:4
We randomly assigned 41 individuals to a stretching and relaxation group.
compared effects on HbA1C on aerobic only, resistance only, combination of aerobic and resistance, and a stretching & relaxing groups.

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Hemoglobin A1C
時間枠:at 9 months
at 9 months

二次結果の測定

結果測定
時間枠
Fasting glucose
時間枠:at 9 months
at 9 months
Basal insulin
時間枠:at 9 months
at 9 months
Resting blood pressure
時間枠:at 9 months
at 9 months
C reactive protein
時間枠:at 9 months
at 9 months
Visceral adiposity
時間枠:at 9 months
at 9 months
Body Composition
時間枠:at 9 months
at 9 months
Cardiorespiratory fitness
時間枠:at 9 months
at 9 months
Muscular strength
時間枠:at 9 months
at 9 months
metabolic measures, including serum cholesterol and triglycerides
時間枠:at 9 months
at 9 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Timothy S Church, MPH, MD, PhD、Pennington Biomedical Research Center

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2007年4月1日

一次修了 (実際)

2010年3月1日

研究の完了 (実際)

2010年6月1日

試験登録日

最初に提出

2007年4月5日

QC基準を満たした最初の提出物

2007年4月5日

最初の投稿 (見積もり)

2007年4月9日

学習記録の更新

投稿された最後の更新 (実際)

2022年9月15日

QC基準を満たした最後の更新が送信されました

2022年9月13日

最終確認日

2022年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • PBRC 26046
  • R01DK068298 (米国 NIH グラント/契約)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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