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

Study Purpose

the aim of this study will be to investigate the effect of aerobic exercises vs.#46;incentive spirometer device on post-covid patients with residual lung diseases.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 40 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - Hemodynamic Instability.
  • - Severe Head Injury.
  • - Increased intracranial pressure.
  • - Anemic Hb<8.
  • - Active Smoking.
  • - Severe Bronchospasm.
  • - Low BP (systole <80, diastole <60).
  • - Subcutaneous Emphysema.
  • - Rip Fractures.
  • - Untreated Pneumothorax.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06191367
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 McCarious Nahad Aziz Abdelshaheed Stephens
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Mohamed H Elgendy, Doctoral
Principal Investigator Affiliation Physiotherapy Faculty, Cairo University.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Active, not recruiting
Countries Egypt
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Lung Fibrosis Interstitial, Post-COVID-19 Syndrome
Additional Details

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:

  • - Group I (experimental) will receive aerobic exercises program and traditional chest physiotherapy.
  • - Group II (experimental) will receive incentive spirometer device treatment and traditional chest physiotherapy.
  • - Group III (control) will receive traditional chest physiotherapy only.
The measures will be taken before and after treatment program.

Arms & Interventions

Arms

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

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).

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

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).

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

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.

Interventions

Other: - Aerobic Exercises

Aerobic Exercises

Device: - Incentive Spirometer Device

is a handheld medical device used to help patients improve the functioning of their lungs. By training patients to take slow and deep breaths, this simplified spirometer facilitates lung expansion and strengthening. Patients inhale through a mouthpiece, which causes a piston inside the device to rise. This visual feedback helps them monitor their inspiratory effort. Incentive spirometers are commonly used after surgery or other illnesses to prevent pulmonary complications.

Other: - Traditional Chest Physiotherapy

1. Breathing exercise. 2. Postural drainage. 3. Percussion. 4. Coughing. 5. Vibration.

Contact a Trial Team

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International Sites

Cairo, Egypt

Status

Address

Physiotherapy department Police Academy Hospital

Cairo, ,

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