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临床试验/CTRI/2025/03/082174
CTRI/2025/03/082174尚未招募不适用

Effect of Instrumented and Non Instrumented Breathing Exercise Along With Endurance Training On Pulmonary Functions And Functional Capacity Of Obese Hypertensive Individuals An Experimental Study

Datta Meghe College Of Physiotherapy1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年3月17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
130
试验地点
1
主要终点
To assess the pulmonary functions with the help of Pulmonary Function Tests (FVC, FEV1, PEF and FVC/FEV1)

研究概览

简要总结

This study focuses on assessing the impact of instrumented and non-instrumented breathing exercises, combined with endurance training, on the pulmonary functions and functional capacity of obese hypertensive individuals. Hypertension and obesity are significant global health concerns, often occurring together, and are associated with impaired pulmonary function, reduced exercise tolerance, and an increased risk of cardiovascular diseases. Effective interventions are needed to address these complications and improve the quality of life for affected individuals.

The study will include 130 participants aged 30-60 years with a history of hypertension (≥5 years) and obesity (BMI ≥30 kg/m²). Participants will be divided into two groups. Group 1 will perform endurance training combined with incentive spirometry, while Group 2 will perform endurance training combined with inspiratory diaphragm breathing (IDB) and expiratory pursed-lip breathing (EPLB) exercises. Both groups will follow a structured 4-week program consisting of treadmill and cycling exercises at low intensity (not exceeding 20% of HRR), gradually increasing in duration over the weeks. Each group will also perform their respective breathing exercises for 15 minutes, 5 days a week.

Outcome measures include pulmonary function tests (FVC, FEV1, PEF) and functional capacity, assessed through the 6-minute walk test (6MWT), will be measured before and after the intervention. By comparing the results, the study aims to determine the effectiveness of instrumented versus non-instrumented breathing exercises in improving respiratory health and functional endurance.

This research is designed to explore optimal rehabilitation strategies for obese hypertensive individuals, offering evidence-based approaches to enhance lung function, exercise tolerance, and overall well-being.

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
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Participants who are willing to participate.
  • 2.History of hypertension ≥5 years.
  • 3.Hypertensive individuals with BP ≥ 140/90 mmHg. 4.Obese individuals with BMI of ≥ 30 kg/m2.

排除标准

  • 1.History of Smoking and Diabetes.
  • 2.Presence of any chronic pulmonary disease, neuromuscular disease, cardiovascular disease other than Hypertension.
  • 3.Airway infection or acute asthma in a month before enrolment and during the study.
  • 4.Severe orthopedic problems with a significant impact on daily activities.
  • 5.Presence of any psychiatric or cognitive disorder.

结局指标

主要结局

To assess the pulmonary functions with the help of Pulmonary Function Tests (FVC, FEV1, PEF and FVC/FEV1)

时间窗: Pre-intervention and Post-intervention 4th week.

次要结局

  • To check the endurance with the help of 6MWT (distance walked)(Pre-intervention and Post-intervention 4th week.)

研究者

发起方
Datta Meghe College Of Physiotherapy
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Bhiniksha Mandlik

Datta Meghe College of Physiotherapy

研究点 (1)

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