Pulmonary Fibrosis
Conditions
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.
Detailed description
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
Interventions
OTHERDiaphragmatic Release Technique (DRT)
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.
OTHERTargeted 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.
Sponsors
Pharos University in Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks | Baseline (Week 0) and Post-Intervention (Week 12). | Forced Expiratory Volume in 1 second measured in liters (L) via spirometry to evaluate airway patency and expiratory capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Functional Exercise Capacity (6MWT) at 12 Weeks | Baseline (Week 0) and Post-Intervention (Week 12). | 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. |
| Change from Baseline Dyspnea Severity (mMRC Scale) at 12 Weeks | Baseline (Week 0) and Post-Intervention (Week 12). | : 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. |
Contacts
CONTACTola m elghary, Lecturer
Outcome results
None listed