Comparison of Thoracic Squeeze and Manual Diaphragmatic Release Technique in COPD Patients

Not Applicable

Not yet recruiting

• Conditions: COPD (Chronic Obstructive Pulmonary Disease)

• Registration Number: NCT06791239
• Lead Sponsor: Riphah International University

Brief Summary

The goal of this randomized control trial is to evaluate and compare the efficacy of two physiotherapy techniques-Thoracic Squeeze Technique (TST) and Manual Diaphragmatic Release Technique (MDRT)-on improving respiratory parameters, functional capacity, and quality of life in patients with mild to moderate Chronic Obstructive Pulmonary Disease (COPD).

Objectives:

* Assess the impact of TST and MDRT on respiratory parameters (FEV1, FVC, FEV1/FVC ratio, and chest expansion).

* Compare the functional capacity outcomes of the two techniques using the 6-Minute Walk Test (6MWT).

* Evaluate the effects of TST and MDRT on patient wellbeing and daily life through the COPD Assessment Test (CAT).

Study Design:

The study involves 34 participants, divided into two groups (n=17 each) via sealed envelope randomization. Both groups will receive their respective interventions (TST or MDRT) alongside a standardized pulmonary rehabilitation protocol (pursed-lip breathing, diaphragmatic breathing, active cycle of breathing, and endurance exercises). The intervention will be conducted three times per week for three weeks.

Outcome Measures:

Primary outcomes include respiratory parameters assessed through spirometry and chest expansion using a measuring tape. Secondary outcomes include functional capacity (6MWT) and patient wellbeing (CAT scores). Baseline and post-intervention measures will be analyzed using SPSS, employing Mixed ANOVA to determine interaction effects.

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) is a chronic inflammatory condition of the respiratory system that progressively impairs airflow, leading to significant limitations in physical capacity and quality of life. COPD is a global health concern, being the third leading cause of death worldwide, with an increasing prevalence due to aging populations and environmental pollution. Despite advancements in pharmacological treatments, COPD management requires comprehensive rehabilitation strategies, particularly for improving respiratory function and functional capacity.

Two physiotherapy techniques, the Thoracic Squeeze Technique and Manual Diaphragmatic Release Technique, have been individually employed to address respiratory function in COPD patients. However, direct comparisons of their effectiveness on respiratory parameters, functional capacity, and overall quality of life are scarce. This study aims to evaluate and compare the effects of these techniques, combined with conventional pulmonary rehabilitation, to identify the more effective intervention for optimizing COPD treatment.

The trial will be conducted at Lady Reading Hospital, Peshawar, over six months following ethical approval.

This study will provide evidence-based insights into the relative efficacy of Thoracic Squeeze and Manual Diaphragmatic Release techniques. Findings will guide physiotherapists in optimizing rehabilitation protocols for COPD patients, improving respiratory function, functional capacity, and overall quality of life. Moreover, the research aims to contribute to the standardization of physiotherapy practices for COPD management, ensuring consistent and effective patient care.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Study Start: 2025-02-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

• Patients with mild or moderate COPD according to the GOLD criteria.GOLD 1: Mild FEV1 ≥ 80% predicted value, GOLD 2: Moderate FEV1 between 50% and 80% predicted value.
• Age between 40- 60 years.
• Both male and female.
• Patients who are willing to give voluntary consent to practice.

Exclusion Criteria

• Patients with unstable hemodynamic parameters (arterial pressure <100mmHg Systolic and <60 mmHg diastolic blood pressure.
• Patients who have undergone recent 6 to 12 weeks cardio thoracic or abdominal surgery.
• Patients who have a recent history of chest wall or abdominal trauma; substantial chest wall deformity History of recent fractures and cognitive impairments.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory parameter FEV1/FVC ratio	1 week	The Gold standard tool used in the diagnosis of COPD is spirometry. In today GOLD guidelines the diagnosis of pulmonary function test based on a bronchodilator FEV1/FVC ratio of less than 0. 7.
Respiratory parameter Forced Expiratory Volume	1 week	Forced Expiratory Volume in 1 Second (FEV1 measures the volume of air that can be forcefully exhaled in the first second serving as an indicator of airway obstruction severity.
Respiratory parameter Forced Vital Capacity (FVC)	1 week	Forced Vital Capacity (FVC) the total volume of air exhale during a forced breath assessing overall lung capacity.
Functional capacity	1 week	Six Minute walk test: The 6-Minute Walk Test (6MWT) is a simple and practical test used to assess the functional exercise capacity of individuals. It measures the distance an individual can walk quickly on a flat hard surface in a period of six minutes. The test is commonly used in patients with chronic respiratory diseases such as COPD.

Secondary Outcome Measures

Name	Time	Method
Chest excursion	1 week	Chest excursion measurement is a simple clinical test used to assess the mobility of thoracic cage during respiration. This can be particularly useful in diagnosing and monitoring respiratory conditions such as COPD to measure lung expansion. Chest expansion will be measured at three levels; Upper Lobe: at the level of the fourth rib. Middle Lobe: at the level of the xiphoid process. Lower Lobe: at the level of the tenth rib.
Quality of life self-administered questionnaire	3 weeks	The COPD assessment test (CAT) is a self-administered questionnaire that consist of eight questions to explore different symptoms and impacts of COPD. .

Trial Locations

Locations (1)

Lady Reading Hospital; 🇵🇰 Peshawar, KPK, Pakistan