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Not yet recruiting NCT06681701

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

No phase Interventional Study the Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combined Manual Therapy and Pulmonary Exercises.
Who it may be relevant to
Registry conditions: Study the Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases. Basic parameters: 50 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • 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 Poste

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Assessment of Chest Expansion and Mobility [Time frame: Eight weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 39022457
  • 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. PMID 38064596

Identifiers

NCT: NCT06681701 · Restrictive lung diseases

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗