Diaphragmatic Release vs Inspiratory Muscle Training in Pulmonary Fibrosis

NCT07810153 | Not Yet Recruiting

• 1 other identifier: PUA-DR-IMT-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Week 0) and Post-Intervention (Week 12).

Secondary Outcomes (2)

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

  Baseline (Week 0) and Post-Intervention (Week 12).

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

  Baseline (Week 0) and Post-Intervention (Week 12).

Study Arms (2)

Diaphragmatic Release Technique (DRT

EXPERIMENTAL

Participants receive manual diaphragmatic release technique (cranial and lateral traction to the rib cage for 10-15 minutes) 3 times per week for 12 weeks alongside standard medical therapy.

Other: Diaphragmatic Release Technique (DRT); Other: Targeted Inspiratory Muscle Training (IMT)

Targeted Inspiratory Muscle Training (IMT)

EXPERIMENTAL

Participants perform targeted inspiratory muscle training using a threshold inspiratory muscle trainer device (5-7 sets of 6-10 breaths at 30-40% perceived effort) 3 times per week for 12 weeks alongside standard medical therapy

Other: Diaphragmatic Release Technique (DRT); Other: Targeted Inspiratory Muscle Training (IMT)

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.

Diaphragmatic Release Technique (DRT; Targeted Inspiratory Muscle Training (IMT)

Targeted Inspiratory Muscle Training (IMT) 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.

Also known as: (IMT)

Diaphragmatic Release Technique (DRT; Targeted Inspiratory Muscle Training (IMT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharos University in Alexandria: lead

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ola m elghary, Lecturer

CONTACT

01227191398; ola.elgohary@pua.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind study (Outcomes Assessor). The outcome assessors responsible for evaluating spirometry, the 6-minute walk test, dyspnea scores, and quality of life questionnaires will be blinded to the participants' group assignments to minimize measurement bias. Due to the physical nature of manual therapy and exercise training interventions, double-blinding is not feasible for participants or treating therapists.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy

Model Details: This means participants are assigned to one of two groups simultaneously and remain in that specific group throughout the entire study: Group A for Diaphragmatic Release Technique, or Group B for Inspiratory Muscle Training)

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09