Clinical trial NCT06681701: Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases
Official title: Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Study the Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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:
Primary purpose: TREATMENT

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

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

Primary outcomes:
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
timeFrame: Eight weeks
Secondary outcomes:
measure: Assessment of Chest Expansion and Mobility
timeFrame: Eight weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.