Diaphragmatic Release vs Inspiratory Muscle Training in Pulmonary Fibrosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPharos University in Alexandria

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed clinical diagnosis of stable pulmonary fibrosis (diagnosed via HRCT scan and medical evaluation).

Disqualifiers

Acute respiratory exacerbation or hospitalization within the past 4 weeks.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diaphragmatic Release Technique (DRT)

    Other intervention

    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 intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Diaphragmatic Release Technique (DRTExperimental treatment 2 interventions
Group B: Targeted Inspiratory Muscle Training (IMT)Experimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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).
2

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).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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