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Effects of Hourly Stair-Climbing Exercise Snacks on Metabolic and Vascular Health in Adults With Prediabetes (RISE UP)

2026年9月23日 更新者:Hossein Rafiei、St. Louis University

RISE UP: Rapid Intense Stair Exercise for Unleashing Metabolic Potential in Prediabetes

This study will examine whether very short bouts of stair climbing performed throughout the day can improve blood sugar control and cardiovascular health in adults with prediabetes. Participants will complete three separate study visits in random order: uninterrupted sitting, sitting interrupted by 3-minute light walking breaks each hour, and sitting interrupted by brief stair-climbing exercise "snacks" each hour.

During each visit, the research team will measure glucose, insulin, blood lipids, markers of inflammation and oxidative stress, and blood-vessel function. Continuous glucose monitors, blood samples, heart-rate and blood-pressure measurements, vascular ultrasound, and questionnaires will be used to assess the participants' responses.

The goal of the study is to determine whether brief stair-climbing breaks may be a practical way to reduce the negative effects of prolonged sitting and improve metabolic health in adults with prediabetes.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is a single-site, randomized, counterbalanced crossover pilot study evaluating the acute metabolic, vascular, and behavioral effects of interrupting prolonged sitting with brief stair-climbing exercise snacks in adults with prediabetes. A total of 20 participants will complete all three experimental conditions in randomized order, with a washout period of at least 7 days between visits.

The three experimental conditions are: (1) uninterrupted sitting, (2) sitting interrupted each hour by a 3-minute light walking break, and (3) sitting interrupted each hour by a brief stair-climbing exercise snack consisting of approximately 20 seconds of stair ascent at a fast but safe self-selected pace.

Participants will attend each experimental visit after an overnight fast. Two standardized meals will be provided during each approximately 6-hour experimental visit: Meal 1 at the beginning of the postprandial testing period and Meal 2 approximately 180 minutes later. Metabolic responses will be assessed using continuous glucose monitoring and serial blood sampling for glucose, insulin, lipids, inflammatory markers, and oxidative stress markers. Vascular responses will be assessed using noninvasive ultrasound. Heart rate, blood pressure, ratings of perceived exertion, symptoms, and participant-reported feasibility and acceptability will also be assessed.

The study is designed to determine whether brief hourly stair-climbing exercise snacks improve postprandial glucose and insulin responses and other cardiometabolic outcomes compared with uninterrupted sitting and light walking breaks, and to explore the feasibility and acceptability of this approach in adults with prediabetes.

研究の種類

介入

入学 (推定)

20

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。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Missouri
      • St Louis、Missouri、アメリカ、63104

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~69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 18 to 69 years, inclusive. Body mass index (BMI) 25.0 to 40.0 kg/m², inclusive.

Objectively confirmed prediabetes based on at least one of the following:

  • HbA1c 5.7% to 6.4%;
  • fasting plasma glucose 100 to 125 mg/dL; or
  • 2-hour plasma glucose 140 to 199 mg/dL during a 75-g oral glucose tolerance test.

Able to understand study procedures and provide written informed consent in English.

Able to safely perform repeated walking and vigorous stair-climbing activity based on medical history, resting vital signs, PAR-Q+ responses, investigator assessment, and medical clearance when required.

Able to safely undergo repeated venous blood collection and IV-catheter placement.

Able to safely consume the standardized study meals. Willing and able to complete all three experimental conditions and comply with fasting, dietary, physical-activity, medication, and pre-visit standardization instructions.

Exclusion Criteria:

BMI below 25.0 kg/m² or above 40.0 kg/m². Diagnosed type 1 or type 2 diabetes mellitus. Laboratory findings that do not confirm prediabetes or that suggest diabetes, including HbA1c ≥6.5%, fasting plasma glucose ≥126 mg/dL, or 2-hour plasma glucose ≥200 mg/dL during a 75-g oral glucose tolerance test.

Cardiovascular, pulmonary, musculoskeletal, neurological, or other medical conditions that would preclude safe participation in the walking or stair-climbing interventions.

Resting vital signs, current symptoms, or other screening findings indicating that exercise participation would be unsafe.

Pregnancy, plans to become pregnant during the study period, or breastfeeding. Current use of medications that may substantially affect glucose metabolism, lipid metabolism, body weight, study outcomes, or safe participation, including insulin, glucose-lowering medications, GLP-1 receptor agonists, pharmacologic weight-loss medications, systemic corticosteroids, or other medications judged by the investigator to interfere with study outcomes or safety.

Contraindications to vascular ultrasound, repeated blood collection, IV-catheter placement, or exercise participation.

Food allergies, intolerances, or dietary restrictions that prevent safe consumption of the standardized study meals.

Known allergy or severe skin sensitivity to adhesives used with continuous glucose monitors.

Bleeding disorder, current anticoagulant use, history of anemia, recent blood donation, recurrent fainting during blood collection, difficult venous access, or another condition judged to create unacceptable risk from repeated blood sampling or IV-catheter placement.

Inability to safely perform repeated walking or stair climbing. PAR-Q+ result requiring further medical evaluation when the participant does not obtain required written medical clearance.

Any other condition or finding that, in the judgment of the Principal Investigator or qualified study investigator, would make participation unsafe or substantially interfere with completion of study procedures.

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:クロスオーバー割り当て
  • 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
介入なし:Uninterrupted Sitting

Participants will remain seated throughout the approximately 6-hour experimental visit, except as needed for study procedures. At the time points corresponding to activity bouts in the walking and stair-climbing conditions, participants will remain seated. This condition serves as the sedentary control condition.

アクティブコンパレータ:Hourly 3-Minute Light Walking Breaks

Participants will interrupt prolonged sitting with a 3-minute light walking break at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. Walking breaks will therefore occur at 60-minute intervals.

Participants will interrupt prolonged sitting with a 3-minute light walking break at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. Activity breaks are therefore separated by approximately 60 minutes. Participants will otherwise remain seated except as required for study procedures.

実験的:Hourly Stair-Climbing Exercise Snacks

Participants will interrupt prolonged sitting with brief stair-climbing exercise snacks at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. During each bout, participants will ascend approximately three flights of stairs at a fast but safe self-selected pace for about 20 seconds.

Participants will interrupt prolonged sitting with brief stair-climbing exercise snacks at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. During each bout, participants will ascend approximately three flights of stairs at a fast but safe self-selected pace for about 20 seconds. Participants will not run or skip steps, and use of the handrail will be permitted as needed.

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
メジャーの説明
時間枠
6-Hour Postprandial Glucose Area Under the Curve (AUC)
時間枠:From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma glucose will be measured from a fasting venous blood sample obtained before Meal 1 and from serial venous blood samples collected every 30 minutes through 360 minutes after Meal 1 completion. Meal 1 completion will define the start of the postprandial period, and a second standardized meal will be provided at approximately 180 minutes. Plasma glucose AUC will be calculated across the 6-hour experimental period and compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.

From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
6-Hour Postprandial Plasma Insulin Area Under the Curve (AUC)
時間枠:From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma insulin will be measured from a fasting venous blood sample obtained before Meal 1 and from prespecified serial venous blood samples collected through 360 minutes after Meal 1 completion. Meal 1 completion will define time 0, and a second standardized meal will be provided at approximately 180 minutes. Insulin AUC will be calculated across the 0- to 360-minute experimental period and compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.

From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

二次結果の測定

結果測定
メジャーの説明
時間枠
6-Hour Postprandial Plasma Free Fatty Acid Response
時間枠:From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma free fatty acids will be measured from prespecified serial venous blood samples collected during each experimental visit. A fasting baseline sample will be obtained before Meal 1, followed by postprandial sampling through 360 minutes after Meal 1. Free fatty acid responses across the postprandial period will be compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.

From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
6-Hour Postprandial Plasma Triglyceride Response
時間枠:From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma triglycerides will be measured from prespecified serial venous blood samples collected during each experimental visit. A fasting baseline sample will be obtained before Meal 1, followed by postprandial sampling through 360 minutes after Meal 1. Triglyceride responses across the postprandial period will be compared among the three experimental conditions.

From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
Postprandial Plasma Malondialdehyde (MDA)
時間枠:From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma malondialdehyde (MDA), a marker of oxidative stress, will be measured from prespecified venous blood samples collected during each experimental visit. A fasting baseline sample will be obtained before Meal 1, with postprandial assessment through 360 minutes after Meal 1. MDA responses will be compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.

From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
Postprandial Plasma Inflammatory Cytokines (TNF-α and IL-6)
時間枠:From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) will be measured from prespecified venous blood samples collected during each experimental visit. A fasting baseline sample will be obtained before Meal 1, with postprandial assessment through 360 minutes after Meal 1. TNF-α and IL-6 responses will be compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.

From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
Change in Superficial Femoral Artery Diameter
時間枠:Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion

Superficial femoral artery diameter will be assessed using noninvasive Duplex ultrasound before and after each experimental condition. B-mode ultrasound images will be used to quantify arterial diameter, and changes will be compared among uninterrupted sitting, hourly light walking breaks, and hourly stair-climbing exercise snacks.

Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion
Change in Superficial Femoral Artery Blood-Flow Velocity
時間枠:Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion

Superficial femoral artery blood-flow velocity will be assessed using Doppler ultrasound before and after each experimental condition. Changes in blood-flow velocity will be compared among uninterrupted sitting, hourly light walking breaks, and hourly stair-climbing exercise snacks.

Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion
Change in Superficial Femoral Artery Shear Pattern
時間枠:Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion

Superficial femoral artery shear patterns will be derived from vascular ultrasound measurements obtained before and after each experimental condition. Changes in shear patterns will be compared among uninterrupted sitting, hourly light walking breaks, and hourly stair-climbing exercise snacks.

Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion
Heart Rate Response to Activity Bouts
時間枠:Immediately before and immediately after activity bouts at approximately 30, 90, 150, 210, 270, and 330 minutes after Meal 1 completion

Heart rate will be recorded immediately before and immediately after each walking or stair-climbing bout, with measurements obtained at corresponding matched time points during the uninterrupted-sitting condition. Heart rate responses will be compared among the three experimental conditions.

Immediately before and immediately after activity bouts at approximately 30, 90, 150, 210, 270, and 330 minutes after Meal 1 completion
Rating of Perceived Exertion During Activity Bouts
時間枠:Immediately after activity bouts at approximately 30, 90, 150, 210, 270, and 330 minutes after Meal 1 completion

Rating of perceived exertion will be assessed using the Borg Rating of Perceived Exertion Scale (6-20) immediately after each walking and stair-climbing bout. Higher scores indicate greater perceived exertion. Ratings will be used to characterize perceived exercise intensity across the active conditions.

Immediately after activity bouts at approximately 30, 90, 150, 210, 270, and 330 minutes after Meal 1 completion
End-of-Study Acceptability and Practicality Questionnaire Responses
時間枠:After completion of the final experimental visit, approximately 3 to 6 weeks after enrollment

Participants will complete the RISE UP End-of-Study Acceptability, Practicality, and Potential Adoption Questionnaire after the final experimental visit. Items assess acceptability, enjoyment, practicality, confidence, perceived usefulness, and willingness for future adoption. Agreement items use a 5-point response scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Higher scores indicate greater agreement with the individual statement. Because the questionnaire includes both positively and negatively worded items and no overall score will be calculated, higher scores do not uniformly indicate a better or worse outcome. Individual questionnaire items will be summarized separately.

After completion of the final experimental visit, approximately 3 to 6 weeks after enrollment
Participant-Reported Barriers and Facilitators to Implementation
時間枠:After completion of the final experimental visit, approximately 3 to 6 weeks after enrollment

Participants will report perceived barriers and facilitators to implementing brief stair-climbing exercise snacks in daily life using questionnaire items and open-ended responses. Closed-ended barrier items use a 5-point response scale ranging from 1 (Strongly disagree) to 5 (Strongly agree), with higher scores indicating greater agreement that the specified factor represents a barrier. Open-ended responses will be summarized qualitatively. No overall barriers or facilitators score will be calculated.

After completion of the final experimental visit, approximately 3 to 6 weeks after enrollment

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

捜査官

  • 主任研究者:Hossein Rafiei, PhD, RD, ACSM-CPT、St. Louis University

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 (推定)

2026年10月1日

一次修了 (推定)

2027年7月1日

研究の完了 (推定)

2027年7月1日

試験登録日

最初に提出

2026年9月16日

QC基準を満たした最初の提出物

2026年9月23日

最初の投稿 (実際)

2026年9月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月29日

QC基準を満たした最後の更新が送信されました

2026年9月23日

最終確認日

2026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

  • STUDY00000085
  • PROJ-000884 (その他の助成金/資金番号:Saint Louis University)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

De-identified individual participant data underlying the results reported in the primary publication may be shared upon reasonable request to the Principal Investigator, subject to institutional policies, applicable ethical and privacy requirements, and execution of an appropriate data-use agreement when required.

IPD 共有時間枠

Beginning 6 months after publication of the primary study results and continuing for 5 years.

IPD 共有アクセス基準

De-identified individual participant data underlying the published results and selected supporting materials may be made available to qualified researchers upon reasonable request to the Principal Investigator. Requests should include a scientifically sound proposal describing the planned analyses and intended use of the data. Access will be subject to applicable Saint Louis University policies, ethical and privacy requirements, and execution of a data-use agreement when required. Data will not include direct participant identifiers.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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