Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases

NCT ID: NCT06681701

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-07-15

Brief 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. 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

Conditions

Study the Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group B (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:

Group Type: EXPERIMENTAL

Combined Manual Therapy and Pulmonary Exercises

Intervention Type: PROCEDURE

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:

Group A (control)

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.

Group Type: ACTIVE_COMPARATOR

Combined Manual Therapy and Pulmonary Exercises

Intervention Type: PROCEDURE

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:

Interventions

Combined Manual Therapy and Pulmonary Exercises

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:

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Restrictive lung diseases pneumonia pulmonary edema pleural effusion pneumothorax

Exclusion Criteria

hiatus hernia substantial gastro-esophageal reflux acute cardiac events osteoporosis congestive heart failure active hemoptysis malignant disease

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Abuzaid

Director, Head of Department of Physiotherapy for Cardiovascular/Respiratory and Geriatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 39022457 (View on PubMed)

Wang 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.

Reference Type: BACKGROUND

PMID: 38064596 (View on PubMed)

Other Identifiers

Restrictive lung diseases

Identifier Type: -

Identifier Source: org_study_id