Clinical trial NCT06791239: Comparison of Thoracic Squeeze and Manual Diaphragmatic Release Technique in COPD Patients
Official title: Comparison of Thoracic Squeeze and Manual Diaphragmatic Release Technique on Respiratory Parameters and Functional Capacity in COPD Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: Thoracic squeeze technique
Manual diaphragmatic release technique
COPD
digital spirometry
functional capacity
quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 34
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Respiratory parameter FEV1/FVC ratio
timeFrame: 1 week
measure: Respiratory parameter Forced Expiratory Volume
timeFrame: 1 week
measure: Respiratory parameter Forced Vital Capacity (FVC)
timeFrame: 1 week
measure: Functional capacity
timeFrame: 1 week
Secondary outcomes:
measure: Chest excursion
timeFrame: 1 week
measure: Quality of life self-administered questionnaire
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Lady Reading Hospital
state: KPK
Study officials:
affiliation: Riphah International University
name: Maria Naeem, DPT, MS-CPPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braz Junior DS, Dornelas de Andrade A, Teixeira AS, Cavalcanti CA, Morais AB, Marinho PE. Whole-body vibration improves functional capacity and quality of life in patients with severe chronic obstructive pulmonary disease (COPD): a pilot study. Int J Chron Obstruct Pulmon Dis. 2015 Jan 12;10:125-32. doi: 10.2147/COPD.S73751. eCollection 2015.