- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05172102
Quality of Life and Lung Function on Post Covid-19 Patient (Covid-19)
Effect of Breathing Exercise on Chest Expansion, Quality of Life and Lung Function on Post Covid-19 Patient: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maged Basha, PhD
- Phone Number: +966507018798
- Email: Bashamaged@gmail.com
Study Locations
-
-
Qassim
-
Buraidah, Qassim, Saudi Arabia, 2100
- College of medical rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female. Age from 20 to 30 years old. - Body mass index (BMI) 19 to 24 kg/m2.- Non-smoker- Recovered from COVID-19 over the past 12 months. - They are experiencing mild to moderate symptoms without any complications. -
- Able to use online communication programs.
Exclusion Criteria:
- - Anyone who does regular physical exercise.
- history of acute illness, asthma, pulmonary fibrosis, hypertension, diabetes disease.
- hypoxemia in rest.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group
Will receive diaphragmatic breathing with pursed lips as (breathing exercise), They will instruct to perform 3 different conditions will be registered: (1) 6 min of quiet breathing (3 sets of 2 min each), defined as spontaneous breathing pattern; (2) 6 min of diaphragmatic breathing (3 sets of 2 min each); and (3) 6 min of diaphragmatic breathing plus pursed-lips breathing (3 sets of 2 min each). For aerobic exercises: Will include the following exercises: walking, cycling, running and intermittent running. The exercises will perform for 18-60 minutes for 1-2 sets per week. For resistance exercises: Will include the following 8 exercises: shoulder press, biceps curl, triceps curl, bench press, leg squats, leg press, leg curl and toe raise. The exercises will perform for 60 minutes for 2-3 sets per week. |
6 min of quiet breathing (3 sets of 2 min each), 6 min of diaphragmatic breathing (3 sets of 2 min each), 6 min of diaphragmatic breathing plus pursed-lips breathing (3 sets of 2 min each).
Other Names:
|
No Intervention: control group
not receiving any exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-related quality of life, Medical Outcomes Study short-form (SF-36)
Time Frame: at baseline
|
assessed using the Short Form-36 (SF-36).
The SF-36 scale had 8 dimensions, and each dimension was converted into a percentage score.
|
at baseline
|
Health-related quality of life, Medical Outcomes Study short-form (SF-36)
Time Frame: after 6 weeks
|
assessed using the Short Form-36 (SF-36).
The SF-36 scale had 8 dimensions, and each dimension was converted into a percentage score.
|
after 6 weeks
|
Respiratory function measurement
Time Frame: at baseline
|
assessed by a spirometer.
The following parameters related to respiratory function will be measured: (1) forced expiratory volume in 1 second (FEV1); (2) forced vital capacity (FVC).
|
at baseline
|
Respiratory function measurement
Time Frame: after 6 weeks
|
assessed by a spirometer.
The following parameters related to respiratory function will be measured: (1) forced expiratory volume in 1 second (FEV1); (2) forced vital capacity (FVC).
|
after 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chest expansion measurement
Time Frame: at baseline
|
measured with a tape measure at 2 different levels of the rib cage.
Measurements will be taken at the maximal inspiration and expiration
|
at baseline
|
Chest expansion measurement
Time Frame: after 6 weeks
|
measured with a tape measure at 2 different levels of the rib cage.
Measurements will be taken at the maximal inspiration and expiration
|
after 6 weeks
|
Exercise endurance measurement
Time Frame: at baseline
|
measured by the 6-min walk test (6MWT), is the distance one walks within 6 min
|
at baseline
|
Exercise endurance measurement
Time Frame: after 6 weeks
|
measured by the 6-min walk test (6MWT), is the distance one walks within 6 min
|
after 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sahar Mahmoud, PhD, Qassim University
Publications and helpful links
General Publications
- Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study. Complement Ther Clin Pract. 2020 May;39:101166. doi: 10.1016/j.ctcp.2020.101166. Epub 2020 Apr 1.
- Mendes LP, Moraes KS, Hoffman M, Vieira DS, Ribeiro-Samora GA, Lage SM, Britto RR, Parreira VF. Effects of Diaphragmatic Breathing With and Without Pursed-Lips Breathing in Subjects With COPD. Respir Care. 2019 Feb;64(2):136-144. doi: 10.4187/respcare.06319. Epub 2018 Aug 28.
- Ubolnuar N, Tantisuwat A, Thaveeratitham P, Lertmaharit S, Kruapanich C, Mathiyakom W. Effects of Breathing Exercises in Patients With Chronic Obstructive Pulmonary Disease: Systematic Review and Meta-Analysis. Ann Rehabil Med. 2019 Aug;43(4):509-523. doi: 10.5535/arm.2019.43.4.509. Epub 2019 Aug 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-04-Q-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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