Study the Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung DiseasesNCT06681701
Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases
A study testing Combined Manual Therapy and Pulmonary Exercises in people with Study the Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases, run by South Valley University.
Trial summary
This research investigates the effect of selective manual therapy techniques on chest expansion, pulmonary function (FVC, FEV1, and FEV1/FVC ratio), and functional capacity, in restrictive lung disease patients. Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Study the Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases
- What is being tested?
- Combined Manual Therapy and Pulmonary Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 15 Jul 2025
- 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 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Restrictive lung diseases pneumonia pulmonary edema pleural effusion pneumothorax
Who cannot join
- hiatus hernia substantial gastro-esophageal reflux acute cardiac events osteoporosis congestive heart failure active hemoptysis malignant disease
About this study
Official title: Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases: a Randomized Control Trial
This research investigates the effect of selective manual therapy techniques on chest expansion, pulmonary function (FVC, FEV1, and FEV1/FVC ratio), and functional capacity, in restrictive lung disease patients. The research hypothesis will be that no statistically significant difference would be found between manual therapy combined to conventional treatment and conventional treatment alone in restrictive lung disease patients.
Read the detailed description
A chest physician diagnosed 72 subjects with mild to moderate restrictive lung diseases based on history, physical examination, and a ratio of FEV1/FVC above 80%. Male subjects meeting the following criteria will be included: age ranged from 50 to 60 years, BMI was 18-25 kg/m2, If a patient had a history of hiatus hernia, substantial gastro-esophageal reflux, osteoporosis, acute cardiac events within the last six weeks, congestive heart failure, acute exacerbation, exacerbation six months before, active hemoptysis, or malignant disease, they will be excluded from the study.
The subjects who consented to will be involved and met the recruitment standards randomly assigned. A computer-generated block randomization program will be used. To eliminate bias between groups, the subjects will be randomized into four-person blocks with a 1:1 allocation ratio. To ensure disguised allocation, the randomization code will be maintained in sealed, opaque envelopes consecutively numbered. A single external party will be responsible for administering the randomization
- Being tested
- Combined Manual Therapy and Pulmonary Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Manual Therapy and Pulmonary ExercisesProcedure or surgery
Diaphragmatic breathing exercise:
Segmental breathing exercises (apical, upper lateral, lower lateral and posterior basal), according to site of consolidation:
Active Cycle Breathing Technique (ACBT):
Intensive spirometry: It encourages patients to take deep breaths, which helps to expand the lungs and prevent complications such as pneumonia.
Rib mobilization from sitting:
Rib mobilization from supine:
Central Posterior-Anterior (PA) mobilization of thoracic facet joints:
Unilateral Posterior-Anterior mobilization of costo-vertebral joints:
Diaphragmatic myofascial release (DMR):
Pectoralis minor myofascial release:
Pectoralis major and pectoral fascia myofascial release:
Sternocleidomastoid myofascial release:
Scalene muscle and neck fascia myofascial release:
Mobilize one side of the chest:
| Study group | Role | What they receive |
|---|---|---|
| Group B (experimental) | Experimental | Group B (experimental) received conventional physiotherapy and manual therapy
Rib mobilization from sitting:
Rib mobilization from supine:
Unilateral Posterior-Anterior mobilization of costo-vertebral joints:
Myofascial release techniques (MRT)
Diaphragmatic myofascial release (DMR):
Pectoralis minor myofascial release:
Pectoralis major and pectoral fascia myofascial release:
Sternocleidomastoid myofascial release:
Scalene muscle and neck fascia myofascial release:
Mobilize one side of the chest: Receives: Procedure: Combined Manual Therapy and Pulmonary Exercises |
| Group A (control) | Active comparator | Group A (control) received conventional physiotherapy
Diaphragmatic breathing exercise:
Segmental breathing exercises (apical, upper lateral, lower lateral and posterior basal), according to site of consolidation:
Active Cycle Breathing Technique (ACBT):
Intensive spirometry: It encourages patients to take deep breaths, which helps to expand the lungs and prevent complications such as pneumonia. Receives: Procedure: Combined Manual Therapy and Pulmonary Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function tests: Assessed by a previously calibrated portable spirometer was used (Niscomed Contec automated spirometer, 97LX89WX36mm). It is a valid test with higher reliability, as ICC = 0.912 for FVC, ICC = 0.953 for FEV1, and ICC = 0.874 for
Pulmonary function tests: Assessed by a previously calibrated portable spirometer was used (Niscomed Contec automated spirometer, 97LX89WX36mm). It is a valid test with higher reliability, as ICC = 0.912 for FVC, ICC = 0.953 for FEV1, and ICC = 0.874 for the FVC/FEV1 ratio. Subjects were advised to sit on a backrest chair, wear a nose clip, inhale deeply, hold the breath, and then exhale through a mouthpiece linked to the spirometry.2: Assessed by a previously calibrated portable spirometer was used (Niscomed Contec automated spirometer, 97LX89WX36mm). It is a valid test with higher reliability, as ICC = 0.912 for FVC, ICC = 0.953 for FEV1, and ICC = 0.874 for the FVC/FEV1 ratio. Subjects were advised to sit on a backrest chair, wear a nose clip, inhale deeply, hold the breath, and then exhale through a mouthpiece linked to the spirometry.2
Measured: Eight weeks
Secondary outcomes (1)
Assessment of Chest Expansion and Mobility
Assessment of Chest Expansion and Mobility: Assessing chest expansion and mobility is crucial for evaluating respiratory function and identifying potential chest wall pathologies. Use a non-stretchable measuring tape to assess chest expansion at three key levels: 2nd Intercostal Space (supramammary area), 4th Intercostal Space (mammary area) and Xiphoid Process (inframammary area). To measure, have the patient exhale fully to establish a baseline measurement, and then instruct them to inhale deeply. Measure the circumference at each level during full inhalation and exhalation. Compare the measurements from both sides of the chest. Normal findings should show symmetric expansion. If one side expands less than the other, it may indicate underlying issues such as lung volume loss or obstruction. Decreased expansion on one side can suggest conditions like pleural effusion, pneumothorax, or lung consolidation. Observing the mediastinum's position can also provide insights; for instance, a
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start15 Mar 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Study the Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung DiseasesStudies 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
- Group B (experimental) received conventional physiotherapy and manual therapy (chest mobilization and myofascial release techniques). Treatments were performed three times weekly for 8 weeks. Chest mobilization (Grade III joint oscillations are administered in three bouts of thirty oscillations per second each repeated 3-5 times) was applied through the following techniques: Rib mobilization from sitting: Rib mobilization from supine: Central Posterior-Anterior (PA) mobilization of thoracic facet joints: Unilateral Posterior-Anterior mobilization of costo-vertebral joints: Myofascial release techniques (MRT) applied through the following (MRT was applied for 3min for each release.). Diaphragmatic myofascial release (DMR): Pectoralis minor myofascial release: Pectoralis major and pectoral fascia myofascial release: Sternocleidomastoid myofascial release: Scalene muscle and neck fascia myofascial release: Mobilize one side of the chest:
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Abuzaid, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681701
- Sponsor's protocol ID
- Restrictive lung diseases
- Status last verified
- Feb 2025
- First submitted
- 7 Nov 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chilhate PK, Lalwani L. Manual Therapy Interventions in Patients With Chronic Obstructive Pulmonary Disease: A Comprehensive Narrative Review. Cureus. 2024 Jun 17;16(6):e62511. doi: 10.7759/cureus.62511. eCollection 2024 Jun.
PubMed 39022457Wang L, Wu X. Clinical Effects of Exercise Combined with Respiratory Training in the Rehabilitation Treatment of Patients with Chronic Obstructive Pulmonary Disease. Altern Ther Health Med. 2024 Aug;30(8):188-194.
PubMed 38064596
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06681701
- Acronym / sponsor ID
- Restrictive lung diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 8 Nov 2024 (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 research investigates the effect of selective manual therapy techniques on chest expansion, pulmonary function (FVC, FEV1, and FEV1/FVC ratio), and functional capacity, in restrictive lung disease patients. The research hypothesis will be that no statistically significant difference would be found between manual therapy combined to conventional treatment and conventional treatment alone in restrictive lung disease patients.
Detailed description
A chest physician diagnosed 72 subjects with mild to moderate restrictive lung diseases based on history, physical examination, and a ratio of FEV1/FVC above 80%. Male subjects meeting the following criteria will be included: age ranged from 50 to 60 years, BMI was 18-25 kg/m2, If a patient had a history of hiatus hernia, substantial gastro-esophageal reflux, osteoporosis, acute cardiac events within the last six weeks, congestive heart failure, acute exacerbation, exacerbation six months before, active hemoptysis, or malignant disease, they will be excluded from the study.
The subjects who consented to will be involved and met the recruitment standards randomly assigned. A computer-generated block randomization program will be used. To eliminate bias between groups, the subjects will be randomized into four-person blocks with a 1:1 allocation ratio. To ensure disguised allocation, the randomization code will be maintained in sealed, opaque envelopes consecutively numbered. A single external party will be responsible for administering the randomization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group B (experimental) received conventional physiotherapy and manual therapy (chest mobilization and myofascial release techniques). Treatments were performed three times weekly for 8 weeks. Chest mobilization (Grade III joint oscillations are administered in three bouts of thirty oscillations per second each repeated 3-5 times) was applied through the following techniques: Rib mobilization from sitting: Rib mobilization from supine: Central Posterior-Anterior (PA) mobilization of thoracic facet joints: Unilateral Posterior-Anterior mobilization of costo-vertebral joints: Myofascial release techniques (MRT) applied through the following (MRT was applied for 3min for each release.). Diaphragmatic myofascial release (DMR): Pectoralis minor myofascial release: Pectoralis major and pectoral fascia myofascial release: Sternocleidomastoid myofascial release: Scalene muscle and neck fascia myofascial release: Mobilize one side of the chest:
| Arm | Type | Receives |
|---|---|---|
| Group B (experimental) | Experimental | Procedure: Combined Manual Therapy and Pulmonary ExercisesGroup B (experimental) received conventional physiotherapy and manual therapy Rib mobilization from sitting: Rib mobilization from supine: Unilateral Posterior-Anterior mobilization of costo-vertebral joints: Myofascial release techniques (MRT) Diaphragmatic myofascial release (DMR): Pectoralis minor myofascial release: Pectoralis major and pectoral fascia myofascial release: Sternocleidomastoid myofascial release: Scalene muscle and neck fascia myofascial release: Mobilize one side of the chest: |
| Group A (control) | Active comparator | Procedure: Combined Manual Therapy and Pulmonary ExercisesGroup A (control) received conventional physiotherapy Diaphragmatic breathing exercise: Segmental breathing exercises (apical, upper lateral, lower lateral and posterior basal), according to site of consolidation: Active Cycle Breathing Technique (ACBT): Intensive spirometry: It encourages patients to take deep breaths, which helps to expand the lungs and prevent complications such as pneumonia. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Restrictive lung diseases pneumonia pulmonary edema pleural effusion pneumothorax
Key exclusion criteria (1 listed)
- hiatus hernia substantial gastro-esophageal reflux acute cardiac events osteoporosis congestive heart failure active hemoptysis malignant disease
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 |
|---|---|---|
| Combined Manual Therapy and Pulmonary ExercisesDiaphragmatic breathing exercise: Segmental breathing exercises (apical, upper lateral, lower lateral and posterior basal), according to site of consolidation: Active Cycle Breathing Technique (ACBT): Intensive spirometry: It encourages patients to take deep breaths, which helps to expand the lungs and prevent complications such as pneumonia. Rib mobilization from sitting: Rib mobilization from supine: Central Posterior-Anterior (PA) mobilization of thoracic facet joints: Unilateral Posterior-Anterior mobilization of costo-vertebral joints: Diaphragmatic myofascial release (DMR): Pectoralis minor myofascial release: Pectoralis major and pectoral fascia myofascial release: Sternocleidomastoid myofascial release: Scalene muscle and neck fascia myofascial release: Mobilize one side of the chest: | Procedure or surgery | Group A (control), Group B (experimental) |
Primary outcome
Pulmonary function tests: Assessed by a previously calibrated portable spirometer was used (Niscomed Contec automated spirometer, 97LX89WX36mm). It is a valid test with higher reliability, as ICC = 0.912 for FVC, ICC = 0.953 for FEV1, and ICC = 0.874 for
Time frame: Eight weeks
Pulmonary function tests: Assessed by a previously calibrated portable spirometer was used (Niscomed Contec automated spirometer, 97LX89WX36mm). It is a valid test with higher reliability, as ICC = 0.912 for FVC, ICC = 0.953 for FEV1, and ICC = 0.874 for the FVC/FEV1 ratio. Subjects were advised to sit on a backrest chair, wear a nose clip, inhale deeply, hold the breath, and then exhale through a mouthpiece linked to the spirometry.2: Assessed by a previously calibrated portable spirometer was used (Niscomed Contec automated spirometer, 97LX89WX36mm). It is a valid test with higher reliability, as ICC = 0.912 for FVC, ICC = 0.953 for FEV1, and ICC = 0.874 for the FVC/FEV1 ratio. Subjects were advised to sit on a backrest chair, wear a nose clip, inhale deeply, hold the breath, and then exhale through a mouthpiece linked to the spirometry.2
1 secondary outcome
Assessment of Chest Expansion and Mobility
Time frame: Eight weeks
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 11 Feb 2025.
- Background: PubMed 39022457Chilhate PK, Lalwani L. Manual Therapy Interventions in Patients With Chronic Obstructive Pulmonary Disease: A Comprehensive Narrative Review. Cureus. 2024 Jun 17;16(6):e62511. doi: 10.7759/cureus.62511. eCollection 2024 Jun.
- Background: PubMed 38064596Wang L, Wu X. Clinical Effects of Exercise Combined with Respiratory Training in the Rehabilitation Treatment of Patients with Chronic Obstructive Pulmonary Disease. Altern Ther Health Med. 2024 Aug;30(8):188-194.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Manual Therapy and Pulmonary Exercises in people with Study the Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases, run by South Valley University.
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 1 inclusion and 1 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 11 Feb 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function tests: Assessed by a previously calibrated portable spirometer was used (Niscomed Contec automated spirometer, 97LX89WX36mm). It is a valid test with higher reliability, as ICC = 0.912 for FVC, ICC = 0.953 for FEV1, and ICC = 0.874 for (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06681701, which also lists 2 linked publications.
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 11 Feb 2025.