Diaphragmatic Release vs Inspiratory Muscle Training in Pulmonary Fibrosis

Sponsor
Pharos University in Alexandria
Study ID
NCT07810153
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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
    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.

Study Details

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.

Key Dates

First listed
Sep 9, 2026
Start date
Oct 10, 2026
Status verified
Sep 2026
Primary completion
Jan 10, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Diaphragmatic Release Technique (DRT
    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.
  • Experimental: Targeted Inspiratory Muscle Training (IMT)
    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

Primary Outcome Measure

Change from Baseline Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks [ Time Frame: Baseline (Week 0) and Post-Intervention (Week 12). ]

Central Contacts

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