Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study (IMPACT)
2021年3月15日 更新者：Latha Palaniappan, MD, MS、Stanford University
The Initiate and Maintain Physical Activity in Clinics (IMPACT) study will determine the optimal and feasible level of frequency of structured contact needed in a clinical setting for adult patients with Type 2 Diabetes Mellitus to initiate and maintain physical activity recommendations long-term.
調査の概要
詳細な説明
The IMPACT Study will compare the health outcomes and lifestyle habits amongst the three groups of study participants.
Study participants will be randomized into three exercise group.
Group 1 will participate in instructor-led exercise training sessions 1 time per week, for 24 weeks (approximately 6 months).
Group 2 will participate in instructor-led exercise training sessions 3 times per week, for 24 weeks (approximately 6 months).
Group 3 will not attend any instructor-led exercise training sessions.
All groups will be encouraged to see their usual providers for routine healthcare, and continue their usual medication regimen.
研究の種類
介入
入学 (実際)
354
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
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California
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Palo Alto、California、アメリカ、94304
- Stanford University
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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
18年～80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:
- Recent hemoglobin A1c result between 6.5 and 13.0%
- Diagnosed with Type 2 Diabetes Mellitus
- Able and willing to enroll and meet the requirements of the study
Exclusion Criteria:
- Inability to speak, read or understand English
- Long-term current use or dependency on insulin
- Systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg
- Resting heart rate > 120 bpm
- History of or present heart or cardiovascular conditions
- History of or present respiratory disease
- History of or present spinal cord injury
- History of stroke or Transient Ischemic Attack (TIA)
- History of cancer diagnosis in the past 5 years or present cancer diagnosis
- Medical, psychiatric, behavioral limitations that may interfere with study participation
- Participating in other clinical trials that may interfere with study procedures and outcomes
- Currently pregnant or plans to become pregnant within three years
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Once-Weekly Structured Contact
Participants in the Once Weekly Structured Contact group will take part in an 6-month exercise intervention and attend one structured group exercise session per week.
They will engage in aerobic and resistance training for approximately 80 minutes per exercise session.
Additionally, they will attend three exercise evaluations and six study visits.
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The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting.
Group sessions include Aerobic Training and Combined Training.
Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week.
Participants in both groups will attend three exercise evaluations during the intervention period.
Participants will also use provided logs to track their daily exercise activities outside of group sessions.
Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.
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実験的：Thrice-Weekly Structured Contact
Participants in the Thrice-Weekly Structured Contact group will take part in an 6-month exercise intervention and attend three structured group exercise sessions per week.
In total, they will engage in aerobic and resistance training sessions for approximately 200 minutes per week.
Additionally, they will attend three exercise evaluations and six study visits.
|
The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting.
Group sessions include Aerobic Training and Combined Training.
Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week.
Participants in both groups will attend three exercise evaluations during the intervention period.
Participants will also use provided logs to track their daily exercise activities outside of group sessions.
Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.
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介入なし：Usual Care
Participants in the Usual Care group will not take part in an 6-month exercise intervention.
They will continue to seek regular care from their primary care providers and attend six study visits.
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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 |
|---|---|
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Changes in Hemoglobin A1c Level Across Study Visits
時間枠：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Changes in Maximal Oxygen Consumption Across Study Visits
時間枠：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Changes in Self-Reported Physical Activity Level Across Study Visits
時間枠：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Changes in Body Weight Across Study Visits
時間枠：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Changes in Body Mass Index Across Study Visits
時間枠：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Changes in Waist Circumference Across Study Visits
時間枠：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Changes in Blood Pressure Across Study Visits
時間枠：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Changes in Heart Rate Across Study Visits
時間枠：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Changes in Dietary Intake Across Study Visits
時間枠：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Changes in Self-Reported Quality of Life Across Study Visits
時間枠：Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Changes in Exercise Perception Across Study Visits
時間枠：Baseline, 6-, 30-month follow-up
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Baseline, 6-, 30-month follow-up
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Changes in Patient Satisfaction During Intervention Period
時間枠：3-, 6-month follow-up
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3-, 6-month follow-up
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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。
スポンサー
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 (実際)
2016年10月1日
一次修了 (実際)
2020年1月1日
研究の完了 (実際)
2020年1月1日
試験登録日
最初に提出
2014年2月11日
QC基準を満たした最初の提出物
2014年2月11日
最初の投稿 (見積もり)
2014年2月13日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月17日
QC基準を満たした最後の更新が送信されました
2021年3月15日
最終確認日
2021年3月1日
詳しくは
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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