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临床试验/CTRI/2024/12/078454
CTRI/2024/12/078454尚未招募不适用

Association of kinesiophobia with physical function, mental health and health related quality of life in patients with Ischemic Heart Disease – A cross sectional study

MGM School of Physiotherapy, MGM Insitute of Health Sciences1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2025年1月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
111
试验地点
1
主要终点
Tampa scale for kinesiophobia

研究概览

简要总结

This study aims to explore the association of kinesiophobia (fear of movement) with physical function, mental health, and health-related quality of life in patients with Ischemic Heart Disease (IHD). IHD, also known as coronary artery disease, is a leading cause of morbidity and mortality globally, and its prevalence has been increasing in India due to rising risk factors like diabetes, hypertension, and physical inactivity. Kinesiophobia, commonly seen in cardiac patients, can hinder physical rehabilitation, as patients may avoid physical activity due to fear of re-injury or symptoms like angina and shortness of breath.

The study will be conducted over 12 months in Navi Mumbai and Raigad districts, involving 111 IHD patients aged 30–75 years. The research will use a cross-sectional design, employing purposive sampling and various validated assessment tools. Key measures will include the Tampa Scale for Kinesiophobia (TSK) to assess fear of movement, and the WHOQOL-BREF, DASS-21, and WHODAS 2.0 to evaluate health-related quality of life, mental health, and disability, respectively. Physical function will be assessed using tests like the 6-minute walk test and muscle strength assessments.

Additionally, the study will investigate patients’ knowledge, attitudes, and beliefs about physical activity and its relationship with kinesiophobia. Data will be analyzed using descriptive and inferential statistics to determine correlations between kinesiophobia and the various health outcomes.

The goal is to understand how kinesiophobia affects both the physical and psychological aspects of IHD patients’ lives and to identify factors influencing their attitudes toward exercise, with a view to improving rehabilitation adherence and overall quality of life.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • IHD managed conservatively and surgically (PTCA and CABG).

排除标准

  • Exclusion criteria comprised patients with unstable angina or myocardial infarction within the previous month, impaired cognition, or a resting heart rate exceeding 120 beats per minute.
  • Individuals with systolic blood pressure above 180 mmHg or diastolic blood pressure exceeding 100 mmHg, severe valvular dysfunction, or pain intensity greater than 5 on the Numeric Rating Scale (NRS) were also excluded.
  • Additional exclusions included those with musculoskeletal conditions such as unhealed fractures or osteoarthritis graded above 2, as well as patients diagnosed with neurological disorders (ICD G00-G99) or psychological disorders (ICD F00-F99).

结局指标

主要结局

Tampa scale for kinesiophobia

时间窗: the outcome measure will be assessed one time as it is cross sectional study

次要结局

  • NRS scale(NYHA scale)

研究者

发起方
MGM School of Physiotherapy, MGM Insitute of Health Sciences
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Iffat Mohmadali Khatib

MGM Institue of Health Sciences

研究点 (1)

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