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A Physical Activity Programme Focussed on Step Volume and Intensity for People With Cardiovascular Disease: Getting Active and Staying Active After Cardiac Rehabilitation (STEP COACH RCT)

2026年7月20日 更新者：Radboud University Medical Center

Step Targets for Patients With Coronary Artery Disease: Towards Better Physical Activity Adherence Following Cardiac Rehab - A Randomised Controlled Trial

The goal of this clinical trial is to learn about the effect of a physical activity program, focussing on increasing step volume and step intensity (STEP COACH program), compared to usual care in patients with coronary heart problems. The main question it aims to answer is: What is the effect of the STEP COACH program on physical activity levels in patients with coronary artery disease who participated in cardiac rehabilitation?

Participants will be randomised in 2 groups:

  1. Control group who receives usual care (i.e., a 3-month cardiac rehabilitation program);
  2. STEP COACH group who receives usual care and the 9-month STEP COACH program.

Objectively measured changes in physical activity time from pre to post STEP COACH program will be compared between groups to see if participants in the STEP COACH group are able to increase their daily physical activity time more compared to participants in the control group.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

People with coronary artery disease are strongly recommended to participate in cardiac rehabilitation programs to improve clinical outcomes and prevent premature death. However, emerging evidence shows that participation in contemporary cardiac rehabilitation programs does not or minimally impact habitual physical activity patterns, and that time spent in physical activity often decreases after completing these programs. Hence, there is a strong need for novel, complementary lifestyle programs to improve long-term adherence to physical activity guidelines in patients with coronary artery disease, as this could attenuate disease progression and the risk for adverse health outcomes.

The primary aim of this study is to assess the effect of the 9-month STEP COACH intervention on the daily minutes of moderate-to-vigorous intensity physical activity compared to usual care in patients with coronary artery disease.

研究の種類

介入

入学 (推定)

334

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

  • オランダ
      • Arnhem、オランダ、6815AD
        • Rijnstate
      • Nijmegen、オランダ、6525GA
        • Radboud University Medical Center
      • Nijmegen、オランダ、6532SZ
        • Canisius Wilhelmina Ziekenhuis
      • Uden、オランダ、5406PT
        • Bernhoven

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Hospital admission for CAD (ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable angina pectoris (UAP), or stable angina pectoris (AP)) and/or having undergone a percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
  • Referral to cardiac rehabilitation;
  • 18 years of age or older;
  • Able to understand and perform study related procedures.

Exclusion Criteria:

  • Unable to give informed consent;
  • Wheelchair-bound / not physically able to stand or walk;
  • Language barrier;
  • CABG surgery expected within 8 weeks after inclusion;
  • New York Heart Association class III or IV heart failure;
  • Participation in another interventional study targeting physical activity;
  • Already adhering to physical activity guidelines (i.e. on average >8,000 steps/day (smartphone) or >10,000 steps/day (smartwatch or smartband) in the 6 months prior to inclusion).

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：防止
  • 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
介入なし：Usual care group
The usual care group will receive a 3-month cardiac rehabilitation program, as recommended by international guidelines. The cardiac rehabilitation program consists of individual consultations with the nurse specialist on lifestyle, medical and psychosocial wellbeing, and an outpatient exercise program with a physiotherapist.
実験的：STEP COACH intervention group
The intervention group receives a 9-month, nurse-delivered physical activity intervention in addition to cardiac rehabilitation (i.e., usual care).
行動：STEP COACH intervention group
The STEP COACH program will encourage patients to progressively increase the volume (i.e. number of daily steps) and intensity (i.e. cadence >100 steps/min) of habitual physical activity. To promote behaviour change, participants will receive 3 in-person consultations and additional telephone consultations with the nurse and study team, which focus on knowledge, motivation, action planning, self-monitoring, evaluation and long-term maintenance. Participants will use their own smartwatch or smartphone to track and evaluate their habitual physical activity via an online platform.

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
Daily moderate-to-vigorous physical activity (min/day)
時間枠：Baseline (before cardiac rehabilitation) to 9 months (end of STEP COACH program)
Change in moderate-to-vigorous physical activity time, measured using a thigh-worn accelerometer over 7 days
Baseline (before cardiac rehabilitation) to 9 months (end of STEP COACH program)

二次結果の測定

結果測定
メジャーの説明
時間枠
Daily moderate-to-vigorous physical activity (min/day)
時間枠：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 12 months (follow-up)
Changes in moderate-to-vigorous physical activity time, measured using a thigh-worn accelerometer over 7 days
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 12 months (follow-up)
Distance covered during Interval Shuttle Walk Test (m)
時間枠：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
Changes in total distance covered (m) during the interval shuttle walk test, a measure for functional capacity
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
Health-related quality of life
時間枠：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Changes in health-related quality of life (physical, emotional and social domain) will be assessed with the MacNew questionnaire.
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Stress (cortisol) levels
時間枠：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
Changes in cortisol levels, measured by hair sampling from the occipital region.
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
Daily step count (steps/day)
時間枠：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Changes in number of steps/day, measured using a thigh-worn accelerometer over 7 days
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Peak 30-min cadence (steps/min)
時間枠：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Changes in peak 30-min cadence (steps/min), measured using a thigh-worn accelerometer over 7 days
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Time at moderate-to-vigorous walking cadence (min)
時間枠：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Changes in daily time at moderate-to-vigorous walking cadence (i.e., >100 steps/min), measured using a thigh-worn accelerometer over 7 days
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
24-hour movement behaviour distribution
時間枠：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Changes in 24-hour movement behaviour distributions, i.e. daily time sleeping, sedentary, standing, light-intensity physical activity, moderate-intensity physical activity and vigorous-intensity physical activity, measured using a thigh-worn accelerometer over 7 days
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)

その他の成果指標

結果測定
メジャーの説明
時間枠
Cost-effectiveness of the STEP COACH intervention
時間枠：Baseline (before cardiac rehabilitation) to 12 months (follow-up)
The results of the EQ-5D-5L questionnaire (i.e., the participants' health state) will be converted into quality-adjusted life years (QALYs). The costs considered for the cost-effectiveness analysis of the RCT are direct costs of the STEP COACH program and of the care utilisation.
Baseline (before cardiac rehabilitation) to 12 months (follow-up)
Long-term clinical outcomes
時間枠：Baseline (before cardiac rehabilitation) to 15 years of follow-up
All-cause mortality and major adverse cardiac events (MACE)
Baseline (before cardiac rehabilitation) to 15 years of follow-up

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

Radboud University Medical Center

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9月1日

一次修了 (推定)

2028年8月31日

研究の完了 (推定)

2028年8月31日

試験登録日

最初に提出

2026年7月20日

QC基準を満たした最初の提出物

2026年7月20日

最初の投稿 (実際)

2026年7月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月23日

QC基準を満たした最後の更新が送信されました

2026年7月20日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026-19007
  • #03-002-2023-0036 (その他の助成金/資金番号：Dutch Heart Foundation)

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

In line with the Open Science initiative and FAIR principles, metadata of the study will be published on the Open Science Framework and IPD will be available on reasonable request via the corresponding author.

IPD 共有時間枠

IPD will be availabe after publication of the results by the research team.

IPD 共有アクセス基準

All data will be stored in the Digital Research Environment (DRE, mydre. org), an online, cloud- based, globally available research platform. The DRE facilitates users to collaborate on research projects within the boundaries of data management regulations (General Data Protection Regulation and Good Clinical Practice compliant) in a flexible and safe way regarding security, Information and Communication Technology (ICT) infrastructure and audit trail.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

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