NCT06791239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

January 14, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

Thoracic squeeze techniqueManual diaphragmatic release techniqueCOPDdigital spirometryfunctional capacityquality of life

Outcome Measures

Primary Outcomes (4)

  • Respiratory parameter FEV1/FVC ratio

    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.

    1 week

  • Respiratory parameter Forced Expiratory Volume

    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.

    1 week

  • Respiratory parameter Forced Vital Capacity (FVC)

    Forced Vital Capacity (FVC) the total volume of air exhale during a forced breath assessing overall lung capacity.

    1 week

  • Functional capacity

    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.

    1 week

Secondary Outcomes (2)

  • Chest excursion

    1 week

  • Quality of life self-administered questionnaire

    3 weeks

Study Arms (2)

Thoracic squeeze technique

EXPERIMENTAL

The Thoracic Squeeze Technique is a manual physiotherapy intervention aimed at improving lung function, airway clearance, and respiratory mechanics. It involves the application of gentle, rhythmic compression to the chest wall during the exhalation phase of breathing, followed by a release. This technique can be performed with the patient in a sitting, semi-reclined, or supine position, depending on their condition and comfort level.

Other: Thoracic squeeze technique

Manual Diaphragmatic release technique

EXPERIMENTAL

The Manual Diaphragmatic Release Technique is a soft tissue manipulation technique used to improve the mobility, function, and efficiency of the diaphragm. It is commonly applied in physiotherapy, particularly in respiratory, musculoskeletal, and manual therapy practices, to address breathing dysfunctions, postural imbalances, and associated pain or discomfort.

Other: Manual diaphragmatic release technique

Interventions

The Thoracic Squeeze Technique is a manual therapy method used primarily in respiratory physiotherapy to improve lung expansion, enhance respiratory function, and facilitate secretion clearance in patients with respiratory conditions.

Thoracic squeeze technique

The Manual Diaphragmatic Release Technique is a soft tissue manipulation technique used to improve the mobility, function, and efficiency of the diaphragm. It is commonly applied in physiotherapy, particularly in respiratory, musculoskeletal, and manual therapy practices, to address breathing dysfunctions, postural imbalances, and associated pain or discomfort.

Manual Diaphragmatic release technique

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Reading Hospital

Peshawar, KPK, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 25624756BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Naeem, DPT, MS-CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 24, 2025

Study Start

February 1, 2025

Primary Completion

May 30, 2025

Study Completion

June 30, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations