跳至主要内容
临床试验/CTRI/2024/08/072694
CTRI/2024/08/072694尚未招募不适用

Screening of Individuals at risk for Peripheral Arterial Disease in lower extremity and influence of supervised exercise training on physical function and lower extremity vascularization.

Bhoomika Sawant MGM School of Physiotherapy MGM Institute of Health Sciences1 个研究点 分布在 1 个国家目标入组 484 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
484
试验地点
1
主要终点
early identification of risk factors for Peripheral Arterial Disease

研究概览

简要总结

Introduction

Peripheral arterial disease (PAD) is a circulatory condition resulting from reduced blood flow through the arteries, primarily due to atherosclerosis. PAD affects about 10-15% of the population and 20% of people over 60. Despite its prevalence, PAD is often underdiagnosed, especially in developing countries like India. PAD leads to significant physical and psychosocial impairments, increasing the risk of coronary heart disease, cerebrovascular disease, and severe limb complications.

Research Question

To investigate early screening for PAD and the impact of supervised exercise training on physical function, quality of life, and lower limb vascularisation.

Clinical Significance

Effective non-invasive screening tools for PAD are crucial, especially for asymptomatic patients, to improve prognosis. Physical activity can reduce the risk and improve survival in PAD patients. This study aims to develop a novel non-invasive screening tool and a supervised exercise training protocol to enhance physical function and vascularisation in PAD patients.

Aim of the Study

To screen individuals at risk for early signs of PAD in the lower extremities and evaluate the effect of exercise training on physical function, quality of life, and lower extremity vascularisation.

Objectives

  1. Identify early signs of lower extremity PAD in at-risk individuals (e.g., those with diabetes or hypertension).
  2. Study lower extremity vascularisation in activities such as squatting and kneeling in individuals with mild to moderate PAD.
  3. Compare the effect of a 12-week supervised exercise program on physical function, quality of life, and lower extremity vascularisation between a control group and an intervention group.

Conclusion

This study aims to develop a novel non-invasive tool for early diagnosis of PAD and evaluate the benefits of a supervised exercise training protocol, aiming to improve physical function, quality of life, and vascular health in PAD patients

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Males and females with risk factors Either Diabetes or Hypertension With one the following; Smoking, hypercholesteremia, physical Inactivity, Obesity .
  • ABI value 0.7-0.9(mild to moderate affection of Peripheral arterial disease.

排除标准

  • Dementia Induvial with cognitive impairment – inability to follow instructions Amputation Major surgery or myocardial infraction during previous three months Unstable Angina Walking limited by a condition other than leg Ischemia.

结局指标

主要结局

early identification of risk factors for Peripheral Arterial Disease

时间窗: 8 weeks

to understand lower limb vascularisation in ground level activities

时间窗: 8 weeks

to develop a supervised exercise training protocol for improving physical function and quality of life in patients with peripheral arterial diease

时间窗: 8 weeks

次要结局

  • Early identification of Peripheral Arterial Disease using a Novel screening tool(screening tool)

研究者

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

Bhoomika Sawant

MGM School of Physiotherapy,MGM Institute of Health Sciences, Navi Mumbai

研究点 (1)

Loading locations...

相似试验