跳至主要内容
临床试验/NCT06681701
NCT06681701尚未招募不适用

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

South Valley University0 个研究点目标入组 72 人开始时间: 2025年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
72
主要终点
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

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Group A (control) received conventional physiotherapy in the form of deep breathing exercises (diaphragmatic, apical, lower costal), Intensive spirometery (improve deep inspiration) and active range of motion (AROM) of both upper extremities.

Diaphragmatic breathing exercise: S

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.

入排标准

年龄范围
50 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Restrictive lung diseases pneumonia pulmonary edema pleural effusion pneumothorax

排除标准

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

研究组 & 干预措施

Group B (experimental)

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:

干预措施: Combined Manual Therapy and Pulmonary Exercises (Procedure)

Group A (control)

Active Comparator

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.

干预措施: Combined Manual Therapy and Pulmonary Exercises (Procedure)

结局指标

主要结局

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

时间窗: 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

次要结局

  • Assessment of Chest Expansion and Mobility(Eight weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibrahim Abuzaid

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

South Valley University

相似试验