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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Study the Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases
• Intervention / Treatment: Procedure: Combined Manual Therapy and Pulmonary Exercises

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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:	Procedure: 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:
Active Comparator: 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.	Procedure: 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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Eight weeks

Collaborators and Investigators

• Sponsor: South Valley University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2025
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: Restrictive lung diseases

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No