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临床试验/NCT07468955
NCT07468955已完成不适用

The Impact of Cardiac Rehabilitation on Functional Capacity, Depression, Quality of Life, and Sleep Quality in Patients With Heart Disease: A Retrospective Study

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
Functional Capacity

研究概览

简要总结

Objective: This study aimed to retrospectively evaluate the impact of cardiac rehabilitation (CR) on functional capacity, depressive symptoms, health-related quality of life, and sleep quality in patients with heart disease.

Methods: A retrospective analysis was conducted on patients who participated in a structured CR program. Clinical records were reviewed to compare pre- and post-rehabilitation outcomes. Functional capacity was assessed using the 6-Minute Walk Test (6MWT), while depressive symptoms, health-related quality of life, and sleep quality were evaluated using the Beck Depression Inventory (BDI), the Short Form-36 (SF-36), and the Pittsburgh Sleep Quality Index (PSQI), respectively.

详细描述

Background and Rationale:Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide. Comprehensive cardiac rehabilitation (CR) programs are widely recognized as a cornerstone of secondary prevention, aiming to improve physical fitness, psychological well-being, and overall health status in cardiac patients. However, real-world retrospective data assessing the multi-dimensional impact of structured CR-encompassing functional capacity, psychological distress (depressive symptoms), health-related quality of life, and sleep quality-simultaneously remain crucial for optimizing patient care protocols.

Study Objectives:The primary objective of this retrospective study is to evaluate the changes in clinical, functional, and psychosocial outcomes following participation in a structured cardiac rehabilitation program. Specifically, the study aims to compare pre- and post-rehabilitation measures regarding: Functional exercise capacity, depressive symptom severity, health-related quality of life (HRQoL), sleep quality.

Study Design and Patient Population:This study utilizes a retrospective observational design. Clinical records and institutional databases will be systematically reviewed to identify patients with heart disease who were admitted to and completed a structured cardiac rehabilitation program.

Data Collection and Outcome Measures: All patient data regarding baseline characteristics, clinical history, and pre- and post-rehabilitation assessments are routinely collected as part of standard clinical care. The primary and secondary outcome measures to be extracted and analyzed include:

  1. Functional Capacity: Assessed using the 6-Minute Walk Test (6MWT), measuring the distance walked in 6 minutes as an indicator of submaximal aerobic capacity.
  2. Depressive Symptoms: Evaluated via the Beck Depression Inventory (BDI), a self-report questionnaire measuring the severity of depression.
  3. Health-Related Quality of Life (HRQoL): Evaluated using the Short Form-36 (SF-36) health survey, covering both physical and mental component summaries.
  4. Sleep Quality: Assessed using the Pittsburgh Sleep Quality Index (PSQI), measuring sleep habits and disturbances over a 1-month time interval.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with coronary artery disease (CAD), status post-myocardial infarction (MI), stable angina, or those who have undergone cardiac surgery
  • Availability of complete pre- and post-rehabilitation clinical records, including 6-Minute Walk Test (6MWT), BDI, SF-36, and PSQI scores.
  • Patients classified as stable by a cardiologist prior to the initiation of the exercise program.

排除标准

  • Presence of severe orthopedic, neurological, or musculoskeletal disorders that prevent the performance of the 6-Minute Walk Test or exercise training.
  • Patients with severe cognitive impairment
  • Unstable angina pectoris, uncontrolled arrhythmias, or advanced heart failure (NYHA Class IV) that contraindicates aerobic exercise.
  • Patients who dropped out of the rehabilitation program before completion or had more than a 20% absence rate in sessions.
  • Patients who underwent major non-cardiac surgery within the last 3 months.

研究组 & 干预措施

Cardiac Rehabilitation Group

Experimental

Patients in this group participated in a structured, multidisciplinary cardiac rehabilitation program. The intervention included individualized aerobic exercise training, resistance exercises, patient education, and psychosocial counseling.

干预措施: Exercise Based Cardiac Rehabilitation (Other)

结局指标

主要结局

Functional Capacity

时间窗: Baseline and post-intervention (6 week later)

unctional capacity is assessed using the 6-Minute Walk Test (6MWT). The distance walked in 6 minutes is recorded in meters. An increase in distance indicates improved functional exercise capacity.

Change in Depressive Symptom

时间窗: Baseline and post-intervention (6 week later)

Assessed using the Beck Depression Inventory (BDI). The BDI is a 21-item self-report scale. Scores range from 0 to 63, where higher scores indicate more severe depressive symptoms.

Change in Quality of Life

时间窗: Baseline and post-intervention (6 week later)

Assessed using the Short Form-36 (SF-36) Health Survey. It consists of 36 items covering 8 dimensions of health. Scores range from 0 to 100 for each subscale, with higher scores representing better health status.

Change in Sleep Quality

时间窗: Baseline and post-intervention (6 week later)

Assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 individual items generating 7 component scores. The global score ranges from 0 to 21; higher scores indicate poorer sleep quality (scores \>5 suggest significant sleep disturbance).

Functional Capacity

时间窗: Baseline and and post-intervention (6 week later)

unctional capacity is assessed using the 6-Minute Walk Test (6MWT). The distance walked in 6 minutes is recorded in meters. An increase in distance indicates improved functional exercise capacity.

Change in Depressive Symptom

时间窗: Baseline and and post-intervention (6 week later)

Assessed using the Beck Depression Inventory (BDI). The BDI is a 21-item self-report scale. Scores range from 0 to 63, where higher scores indicate more severe depressive symptoms.

Change in Quality of Life

时间窗: Baseline and and post-intervention (6 week later)

Assessed using the Short Form-36 (SF-36) Health Survey. It consists of 36 items covering 8 dimensions of health. Scores range from 0 to 100 for each subscale, with higher scores representing better health status.

Change in Sleep Quality

时间窗: Baseline and and post-intervention (6 week later)

Assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 individual items generating 7 component scores. The global score ranges from 0 to 21; higher scores indicate poorer sleep quality (scores \>5 suggest significant sleep disturbance).

次要结局

未报告次要终点

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ismail Okur

Assit. Prof.

Kutahya Health Sciences University

研究点 (1)

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