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临床试验/NCT05927363
NCT05927363
已完成
不适用

Impact on the Physical Activity Level of Coronary Patients in Phase 3 of a Therapeutic Educational Consolidation Program Involving a "Patient Partner" Associated With a Healthcare Professional. A Randomized Controlled Trial.

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 84 人2024年1月12日

概览

阶段
不适用
干预措施
Controls
疾病 / 适应症
Myocardial Infarction
发起方
Centre Hospitalier Universitaire de Nīmes
入组人数
84
试验地点
1
主要终点
Moderate-to-sustained physical activity in the Experimental Group
状态
已完成
最后更新
3个月前

概览

简要总结

Following myocardial infarction, cardiac rehabilitation has undeniable benefits on criteria such as cardiovascular mortality and coronary recurrence. Cardiac rehabilitation consists of 3 phases:

  1. immediate post-acute, in a cardiology department,
  2. active cardiac rehabilitation for several weeks under medical supervision as an inpatient or outpatient,
  3. Resumption of active life by the patient. Indeed, one of the major aims of secondary prevention is long-term adherence to physical activity.However, only 20% to 40% of coronary patients remain physically active at 6 months or 1 year, and the effects of Phase 2 cardiac rehabilitation are not maintained. Managing to maintain at least a moderate level of physical activity after Phase 2 of CR is a major objective.

Various interventions (booklets, applications, activity programs, motivational talks led by healthcare professionals have been tested and compared with the usual care in Phase 3 cardiac rehabilitation. An effect seems to exist on the level of physical activity reported, but with a significant evaluation bias. This study aims to use accelerometry to evaluate the 6-month efficacy of the therapeutic education program for consolidation in phase 3 of Cardiovascular Rehabilitation involving a patient partner and a caregiver on moderate-to-sustained physical activity (> 3 METs) in coronary patients on Phase 3 of cardiac rehabilitation compared with usual rehabilitation management.

详细描述

Following myocardial infarction, cardiac rehabilitation has shown undeniable benefits on strong criteria such as cardiovascular mortality and coronary recurrence. Cardiac rehabilitation consists of 3 phases: 1. immediate post-acute, in a cardiology department, 2. active cardiac rehabilitation for several weeks under medical supervision as an inpatient or outpatient, 3. Resumption of active life by the patient: one of the major aims of secondary prevention is long-term adherence to physical activity. The importance of phase 2 of cardiac rehabilitation is particularly emphasized and is the subject of recommendations by learned societies. The aim is to re-train the patient under paramedical and medical supervision, and to induce behavioral changes through specific therapeutic education. Exercise re-training aims to increase the patient's cardiorespiratory functional capacity and their ability to do physical activity of moderate-to-sustained intensity. One of the most commonly used units to calculate the intensity of physical activity is the Metabolic Equivalent of Task (MET). The higher the intensity of the activity, the higher the number of METs. Physical activity of at least moderate intensity, as recommended in the long-term care of coronary patients corresponds to 3 METs. The therapeutic objective by international recommendations, and explained to patients during phase 2 CR, is to achieve 150 minutes a week of moderate-to-sustained physical activity (3 METs or more). However, only 20% to 40% of coronary patients remain physically active at 6 months or 1 year, which means that the effects of Phase 2 cardiac rehabilitation are not maintained. Managing to maintain at least a moderate level of physical activity after phase 2 of CR, is a major objective. Various interventions (booklets, applications, activity programs, motivational talks led by healthcare professionals have been tested and compared with the usual care in Phase 3 cardiac rehabilitation. An effect seems to exist on the level of physical activity reported, but with a significant evaluation bias. Objective, validated measures of physical activity such as accelerometry have not proved their long-term efficacy (6 months being the classically explored endpoint). An intervention establishing a patient-centered relationship and cognitive-behavioral elements would seem to be a perspective of choice to be explored, therapeutic education having been little explored in phase 3 of cardiac rehabilitation and in the long term. To address some of the barriers identified in qualitative studies, the joint participation of a "patient partner" would seem to of interest. The PP is a patient who has acquired knowledge of their disease over time, through experience and experience and therapeutic education. They encourage dialogue between care teams and patients, facilitating patients' self-expression, and contributes to a better understanding of the discourse. The hypothesis is that a therapeutic educational consolidation program, involving a "patient partner" associated with a health professional, will increase the level of physical activity of coronary patients in Phase 3 of cardiac rehabilitation. The main objective of this study is to use accelerometry to evaluate the 6-month efficacy of the therapeutic education program for consolidation in phase 3 of Cardiovascular Rehabilitation involving a patient partner and a caregiver on the level of moderate to sustained physical activity (\> 3 METs) in coronary patients on Phase 3 of cardiac rehabilitation compared with usual rehabilitation management.

注册库
clinicaltrials.gov
开始日期
2024年1月12日
结束日期
2025年12月9日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
责任方
Sponsor

入排标准

入选标准

  • Patient of legal age (≥ 18 years).
  • Patient having undergone phase 2 treatment in the cardiovascular rehabilitation department of the CHU for myocardial infarction.
  • Patient with a means of communication that allows easy internet connection (i.e. a smartphone).
  • Patient fluent in French.
  • Patient who has given free informed consent.
  • Patient affiliated or beneficiary of a health insurance scheme.

排除标准

  • Patient with severe or unstable comorbidity (respiratory insufficiency renal failure, decompensated heart failure). heart failure).
  • Patient with unstable angina.
  • Patient with contraindications to physical activity following physical activity following cardiovascular rehabilitation (according to medical discussion, based on the recommendations of the French Society of Cardiology).
  • Patient with no suitable means of communication.
  • Patient under court protection, guardianship or curatorship.
  • Pregnant, parturient or breast-feeding patients.

研究组 & 干预措施

Controls

Patients in Phase 3 of cardiac rehabilitation, undergoing the usual care provided.

Experimental Group

Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.

干预措施: Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnership

Experimental Group

Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.

干预措施: Teleconsultation at 2 months

Experimental Group

Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.

干预措施: Teleconsultation at 4 months

Experimental Group

Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.

干预措施: Remote group education workshop

Experimental Group

Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.

干预措施: Administration of self-questionnaires: IPAQ, EMAPS, the Exercise Confidence Survey, EQ-5D-5L and the Mediterranean diet adherence score.

Experimental Group

Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.

干预措施: 6-minute walk test and administers the modified Borg scale at its conclusion.

Experimental Group

Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.

干预措施: Biological check-up

Experimental Group

Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.

干预措施: Accelerometer

Experimental Group

Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.

干预措施: Administration of a logbook

结局指标

主要结局

Moderate-to-sustained physical activity in the Experimental Group

时间窗: Month 6

The accelerometer will be used to evaluate the 6-month efficacy of the therapeutic educational program for consolidation in Phase 3 of Cardiovascular Rehabilitation involving a patient partner and a caregiver and its affect on the level of moderate-to-sustained physical activity (\> 3 METs) in coronary patients in Phase 3 of cardiac rehabilitation compared with usual rehabilitation management. The amount of moderate-to-sustained physical activity (\> 3 METs) will be measured in minutes per week.

Moderate-to-sustained physical activity in Controls

时间窗: Month 6

The accelerometer will be used to evaluate the 6-month efficacy of the therapeutic educational program for consolidation in Phase 3 of Cardiovascular Rehabilitation involving a patient partner and a caregiver and its affect on the level of moderate-to-sustained physical activity (\> 3 METs) in coronary patients in Phase 3 of cardiac rehabilitation compared with usual rehabilitation management. The amount of moderate-to-sustained physical activity (\> 3 METs) will be measured in minutes per week.

次要结局

  • Triglycerides in the Experimental Group(Month 6)
  • Number of steps taken per week in the Experimental Group(Month 6)
  • Blood pressure in Controls(Month 6)
  • Modified Borg score in Controls(Month 6)
  • Abdominal circumference in Controls(Month 6)
  • Aerobic capacity in the Experimental Group(Month 6)
  • Moderate-to-sustained physical activity in the Experimental Group(Month 3)
  • Moderate-to-sustained physical activity in Controls(Month 3)
  • Number of steps taken per week in Controls(Month 6)
  • Modified Borg score in the Experimental Group(Month 6)
  • Time spent sitting/lying down per week in Controls(Month 6)
  • International Physical Activity Questionnaire Score in the Experimental Group(Month 6)
  • International Physical Activity Questionnaire Score in Controls(Month 6)
  • Time spent sitting/lying down per week in the Experimental Group(Month 6)
  • Blood pressure in the Experimental Group(Month 6)
  • Aerobic capacity in Controls(Month 6)
  • Cholesterol in the Experimental Group(Month 6)
  • Cholesterol in Controls(Month 6)
  • Low-density lipoprotein in Controls(Month 6)
  • High-density lipoprotein in the Experimental Group(Month 6)
  • Abdominal circumference in the Experimental Group(Month 6)
  • Low-density lipoprotein in the Experimental Group(Month 6)
  • High-density lipoprotein in Controls(Month 6)
  • Compliance with medication in the Experimental Group(Month 6)
  • Mediterranean diet adherence test in Controls(Month 6)
  • Understanding barriers to motivation: Experimental group(Month 6)
  • Understanding barriers to motivation in Controls(Month 6)
  • Blood glucose levels in the Experimental Group(Month 6)
  • Motivation for doing physical activity in Controls(Month 6)
  • Triglycerides in Controls(Month 6)
  • Compliance with medication in Controls(Month 6)
  • Exercise Confidence Survey in the Experimental Group(Month 6)
  • Exercise Confidence Survey in Controls(Month 6)
  • Blood glucose levels in Controls(Month 6)
  • Motivation for doing physical activity in the Experimental Group(Month 6)
  • Mediterranean diet adherence test in the Experimental Group(Month 6)
  • Number of steps taken per week in the Experimental Group(Month 0)
  • Number of steps taken per week in the Experimental Group(Month 3)
  • Number of steps taken per week in Controls(Month 0)
  • Number of steps taken per week in Controls(Month 3)
  • Time spent sitting/lying down per week in the Experimental Group(Month 0)
  • Time spent sitting/lying down per week in the Experimental Group(Month 3)
  • Time spent sitting/lying down per week in Controls(Month 0)
  • Time spent sitting/lying down per week in Controls(Month 3)
  • International Physical Activity Questionnaire Score in the Experimental Group(Month 0)
  • International Physical Activity Questionnaire Score in the Experimental Group(Month 3)
  • International Physical Activity Questionnaire Score in Controls(Month 0)
  • International Physical Activity Questionnaire Score in Controls(Month 3)
  • Blood pressure in the Experimental Group(Month 0)
  • Blood pressure in the Experimental Group(Month 3)
  • Blood pressure in Controls(Month 0)
  • Blood pressure in Controls(Month 3)
  • Modified Borg score in the Experimental Group(Month 0)
  • Modified Borg score in the Experimental Group(Month 3)
  • Modified Borg score in Controls(Month 0)
  • Modified Borg score in Controls(Month 3)
  • Abdominal circumference in the Experimental Group(Month 0)
  • Abdominal circumference in the Experimental Group(Month 3)
  • Abdominal circumference in Controls(Month 0)
  • Abdominal circumference in Controls(Month 3)
  • Aerobic capacity in the Experimental Group(Month 0)
  • Aerobic capacity in the Experimental Group(Month 3)
  • Aerobic capacity in Controls(Month 0)
  • Aerobic capacity in Controls(Month 3)
  • Cholesterol in the Experimental Group(Month 0)
  • Cholesterol in the Experimental Group(Month 3)
  • Cholesterol in Controls(Month 0)
  • Cholesterol in Controls(Month 3)
  • Low-density lipoprotein in the Experimental Group(Month 0)
  • Low-density lipoprotein in the Experimental Group(Month 3)
  • Low-density lipoprotein in Controls(Month 0)
  • Low-density lipoprotein in Controls(Month 3)
  • High-density lipoprotein in the Experimental Group(Month 0)
  • High-density lipoprotein in the Experimental Group(Month 3)
  • High-density lipoprotein in Controls(Month 0)
  • High-density lipoprotein in Controls(Month 3)
  • Triglycerides in the Experimental Group(Month 0)
  • Triglycerides in the Experimental Group(Month 3)
  • Triglycerides in Controls(Month 0)
  • Triglycerides in Controls(Month 3)
  • Blood glucose levels in the Experimental Group(Month 0)
  • Blood glucose levels in the Experimental Group(Month 3)
  • Blood glucose levels in Controls(Month 0)
  • Blood glucose levels in Controls(Month 3)
  • Compliance with medication in the Experimental Group(Month 0)
  • Compliance with medication in the Experimental Group(Month 3)
  • Compliance with medication in Controls(Month 0)
  • Compliance with medication in Controls(Month 3)
  • Motivation for doing physical activity in the Experimental Group(Month 0)
  • Motivation for doing physical activity in the Experimental Group(Month 3)
  • Motivation for doing physical activity in Controls(Month 0)
  • Motivation for doing physical activity in Controls(Month 3)
  • Exercise Confidence Survey in the Experimental Group(Month 0)
  • Exercise Confidence Survey in the Experimental Group(Month 3)
  • Exercise Confidence Survey in Controls(Month 0)
  • Exercise Confidence Survey in Controls(Month 3)
  • Mediterranean diet adherence test in the Experimental Group(Month 0)
  • Mediterranean diet adherence test in the Experimental Group(Month 3)
  • Mediterranean diet adherence test in Controls(Month 0)
  • Mediterranean diet adherence test in Controls(Month 3)
  • Understanding barriers to motivation: Experimental group(Month 0)
  • Understanding barriers to motivation: Experimental group(Month 3)
  • Understanding barriers to motivation in Controls(Month 0)
  • Understanding barriers to motivation in Controls(Month 3)

研究点 (1)

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