An interventional study of Diaphragmatic Release Technique (DRT) and Targeted Inspiratory Muscle Training (IMT) in Pulmonary Fibrosis, sponsored by Pharos University in Alexandria. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Pharos University in Alexandria · Not applicable, Interventional, and Treatment
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
342 studies on the registry are indexed under Pulmonary Fibrosis; 98 are open to participants now.
This study's planned enrollment of 40 is below the median of 59 across 212 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Pharos University in Alexandria is the lead sponsor of 22 studies on the registry; 12 are open to participants now.
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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:
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
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)
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)
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.
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)
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).
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).
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.
Of 41 interventional studies with no phase under Pulmonary Fibrosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 81. This study's planned 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Pharos University in Alexandria