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临床试验/NCT06191367
NCT06191367进行中(未招募)不适用

Effect of Aerobic Exercises Versus Incentive Spirometer Device on Post-covid Pulmonary Fibrosis Patients

McCarious Nahad Aziz Abdelshaheed Stephens1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
45
试验地点
1
主要终点
Pulmonary function tests (PFTs).

研究概览

简要总结

the aim of this study will be to investigate the effect of aerobic exercises vs incentive spirometer device on post-covid patients with residual lung diseases.

详细描述

To our knowledge, there have been no enough studies that investigated the effect of aerobic exercise and incentive spirometer in pulmonary rehabilitation on post-covid syndrome patients.

Therefore, this study may open up ways to other researchers to investigate and build up on this effect if present and address such an important issue.

The finding of this proposed work may help patients with post-covid syndrome and complain of lung diseases by addressing their complains of symptoms like chest pain, dyspnea, and cough and provide a possible solution to enhance their quality of life and increase their participation in daily life activities.

Patients of post-covid syndrome with residual lung problems will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo university. All participants will sign a written informed consent form.

The subjects will be randomly assigned into one of three groups:

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
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Hemodynamic stable (MAP not less than 60mmHg, systolic pressure >80mmHg and diastolic pressure not <60mmHg)
  • •Age from 40 to 85 years.
  • •Both sexes.
  • •All patients were positive covid-19 infected patients and passed at least 4 weeks after confirmation.
  • •All patients suffer from respiratory complications.
  • •All patients included are actively breathing.
  • •All patients included are fully aware and conscious.

排除标准

  • •Hemodynamic Instability.
  • •Severe Head Injury.
  • •Increased intracranial pressure.
  • •Anemic Hb<
  • •Active Smoking.
  • •Severe Bronchospasm.
  • •Low BP (systole <80, diastole <60).
  • •Subcutaneous Emphysema.
  • •Rip Fractures.
  • •Untreated Pneumothorax.

研究组 & 干预措施

Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy.

Experimental

It was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received aerobic exercise techniques which consist of 3 levels of activity exercises and traditional program of chest physiotherapy. (Five times per week for two months).

干预措施: Aerobic Exercises (Other)

Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy.

Experimental

It was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received aerobic exercise techniques which consist of 3 levels of activity exercises and traditional program of chest physiotherapy. (Five times per week for two months).

干预措施: Traditional Chest Physiotherapy (Other)

Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy.

Experimental

It was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received incentive spirometer training techniques and traditional program of chest physiotherapy. (Five times per week for two months).

干预措施: Incentive Spirometer Device (Device)

Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy.

Experimental

It was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received incentive spirometer training techniques and traditional program of chest physiotherapy. (Five times per week for two months).

干预措施: Traditional Chest Physiotherapy (Other)

Group III (control) will receive Traditional Chest Physiotherapy only.

Active Comparator

As a control group it was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received traditional program of chest physiotherapy only. (Five times per week for two months).

for example: - Breathing Exercises. - Postural Drainage. - Percussion. - Coughing - Vibration.

干预措施: Traditional Chest Physiotherapy (Other)

结局指标

主要结局

Pulmonary function tests (PFTs).

时间窗: Before and After the treatment program. "8 weeks"

to measure the lungs' capacities and volumes like: FVC, FEV1, and PEF.

Heart rate measurements. (HR).

时间窗: through all the treatment procedures. "8 weeks"

it measures the number of heart bumps in a minute in order to deliver blood to all of the body during Rest and Activity.

Peripheral oxygen saturation level (SpO2).

时间窗: Before and After the treatment program. "8 weeks"

measures the amount of oxygen carried in the blood stream in peripheral limbs.

Six minutes' walk distance test (6MWD).

时间窗: Before and After the treatment program. "8 weeks"

measures the aerobic capacity of the lungs by testing the maximum distance the subject can walk in a 6 minutes time.

次要结局

未报告次要终点

研究者

发起方
McCarious Nahad Aziz Abdelshaheed Stephens
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

McCarious Nahad Aziz Abdelshaheed Stephens

Researcher

Cairo University

研究点 (1)

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