Diaphragmatic Release vs Inspiratory Muscle Training in Pulmonary Fibrosis

N/ANot Yet RecruitingNCT07810153

Pharos University in Alexandria40 enrolled

Overview

This study evaluates the efficacy of adding manual Diaphragmatic Release Technique (DRT) versus Targeted Inspiratory Muscle Training (IMT) to standard medical therapy in patients with stable pulmonary fibrosis. Forty participants are randomly allocated into two equal groups: Group A: Receives manual therapy (cranial and lateral traction to the rib cage for 10-15 minutes) 3 times per week for 12 weeks alongside standard medical care. Group B: Performs targeted inspiratory muscle training using a threshold device (5-7 sets of 6-10 breaths at 30-40% perceived effort) 3 times per week for 12 weeks alongside standard medical care.

Pulmonary fibrosis is characterized by progressive lung parenchyma destruction, resulting in restricted pulmonary function, severe dyspnea, impaired exercise tolerance, and reduced quality of life. While standard pharmacotherapy remains essential, non-pharmacological interventions such as physical therapy techniques are vital to optimize physiological function and functional independence in these patients. This randomized controlled trial aims to compare the therapeutic effects of two distinct physical therapy interventions-Diaphragmatic Release Technique (DRT) and Targeted Inspiratory Muscle Training (IMT)-administered over a 12-week period in patients with stable pulmonary fibrosis. Study Procedures \& Interventions: A total of 40 eligible participants with stable pulmonary fibrosis will be randomly allocated into one of two parallel treatment arms (20 participants per group): Group A (Diaphragmatic Release Technique - DRT): Participants will receive a manual therapy intervention in addition to their standard medical treatment. The therapist applies gentle cranial and lateral traction to the rib cage while the patient is in a supine position to provide a sustained stretch to the diaphragm. Sessions last 10-15 minutes and are conducted 3 times per week for 12 weeks. Group B (Targeted Inspiratory Muscle Training - IMT): Participants will perform targeted inspiratory muscle training using a threshold inspiratory muscle trainer device in addition to their standard medical treatment. Performed in an upright seated position, patients execute deep, forceful inspirations starting at 30-40% of their perceived effort. Each session consists of 5-7 sets of 6-10 breaths (\~15 minutes total), 3 times per week for 12 weeks, with weekly progressive intensity adjustments

Study Type

INTERVENTIONAL

Allocation

Interventions

Diaphragmatic Release Technique (DRT)OTHER

Respiratory muscle resistance training performed in an upright seated position using a pressure-threshold inspiratory muscle trainer device. Protocol consists of 5-7 sets of 6-10 deep inspirations at 30-40% perceived effort (\~15 minutes/session), 3 times per week for 12 weeks, with weekly progressive intensity adjustments.

Targeted Inspiratory Muscle Training (IMT)OTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed clinical diagnosis of stable pulmonary fibrosis (diagnosed via HRCT scan and medical evaluation). Age 18 years or older (both males and females). Clinically stable condition with no acute pulmonary exacerbations or respiratory tract infections within the last 4 weeks. Mild-to-moderate pulmonary restrictive impairment baseline. Ability to follow verbal instructions and perform spirometry testing, 6-minute walk test, and threshold inspiratory muscle training maneuvers. Exclusion Criteria: * Acute respiratory exacerbation or hospitalization within the past 4 weeks. Severe cardiac comorbidities (e.g., unstable angina, recent myocardial infarction, congestive heart failure, or uncontrolled severe hypertension). Severe orthopedic, neuromuscular, or musculoskeletal conditions that prevent participation in exercise training, manual therapy, or 6MWT testing. Recent chest or abdominal surgery (within the past 3 months). Cognitive impairment or psychiatric disorders that impede understanding of instructions or adherence to intervention protocols. Participation in another formal pulmonary rehabilitation program or clinical trial concurrently or within the past 30 days

Outcomes

Primary Outcomes

Change from Baseline Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks

Forced Expiratory Volume in 1 second measured in liters (L) via spirometry to evaluate airway patency and expiratory capacity.

Time frame: Baseline (Week 0) and Post-Intervention (Week 12).

Secondary Outcomes

Change from Baseline Functional Exercise Capacity (6MWT) at 12 Weeks

Functional walking capacity measured as the total distance walked in meters (m) during a standard 6-Minute Walk Test performed on a 30-meter indoor corridor according to ATS guidelines.

Time frame: Baseline (Week 0) and Post-Intervention (Week 12).

Change from Baseline Dyspnea Severity (mMRC Scale) at 12 Weeks

: Severity of dyspnea during daily activities evaluated using the Modified Medical Research Council (mMRC) Dyspnea Scale. Scores range from 0 (no dyspnea except with strenuous exercise) to 4 (too breathless to leave the house), where lower scores indicate less breathlessness.

Time frame: Baseline (Week 0) and Post-Intervention (Week 12).

Diaphragmatic Release vs Inspiratory Muscle Training in Pulmonary Fibrosis

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts