Pulmonary FibrosisDR-IMT-PFNCT07810153
Diaphragmatic Release vs Inspiratory Muscle Training in Pulmonary Fibrosis
A study testing Diaphragmatic Release Technique (DRT) and Targeted Inspiratory Muscle Training (IMT) in people with Pulmonary Fibrosis, run by Pharos University in Alexandria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- Diaphragmatic Release Technique (DRT) and Targeted Inspiratory Muscle Training (IMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Diaphragmatic Release Technique Versus Targeted Inspiratory Muscle Training on Pulmonary Function and Functional Capacity in Patients With Stable Pulmonary Fibrosis: A Randomized Controlled 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.
Read the 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
- Conditions
- Pulmonary Fibrosis
- Being tested
- Diaphragmatic Release Technique (DRT), Targeted Inspiratory Muscle Training (IMT)
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called (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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Diaphragmatic Release Technique (DRT); Other: Targeted Inspiratory Muscle Training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and Post-Intervention (Week 12).
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (Week 0) and Post-Intervention (Week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohamed Elsayed Elgohary, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810153
- Sponsor's protocol ID
- PUA-DR-IMT-01
- Acronym
- DR-IMT-PF
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diaphragmatic Release Technique Versus Targeted Inspiratory Muscle Training on Pulmonary Function and Functional Capacity in Patients With Stable Pulmonary Fibrosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07810153
- Acronym / sponsor ID
- DR-IMT-PF / PUA-DR-IMT-01
- Conditions
- Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic Release Technique (DRT | Experimental | Other: Diaphragmatic Release Technique (DRT), Other: Targeted Inspiratory Muscle Training (IMT)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. |
| Targeted Inspiratory Muscle Training (IMT) | Experimental | 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic 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. | Other | Diaphragmatic Release Technique (DRT, Targeted Inspiratory Muscle Training (IMT) |
| Targeted Inspiratory Muscle Training (IMT)Also: (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. | Other | Diaphragmatic Release Technique (DRT, Targeted Inspiratory Muscle Training (IMT) |
Primary outcome
Change from Baseline Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
Time frame: 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.
2 secondary outcomes
Change from Baseline Functional Exercise Capacity (6MWT) at 12 Weeks
Time frame: Baseline (Week 0) and Post-Intervention (Week 12).
Change from Baseline Dyspnea Severity (mMRC Scale) at 12 Weeks
Time frame: Baseline (Week 0) and Post-Intervention (Week 12).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Release Technique (DRT) and Targeted Inspiratory Muscle Training (IMT) in people with Pulmonary Fibrosis, run by Pharos University in Alexandria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ola m elghary, Lecturer (01227191398, ola.elgohary@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.