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NCT Number: NCT06681701

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

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.

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Key information

Conditions

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

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined Manual Therapy and Pulmonary Exercises

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:

Primary outcomes

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

Secondary outcomes

Assessment of Chest Expansion and Mobility

Time frame: Eight weeks

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

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases: a Randomized Control Trial

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Nov 8, 2024
Registry last updated: Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.