Back to resultsQuality of Life and Lung Function on Post Covid-19 Patient (Covid-19)
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
breathing exercise, Aerobic exercises
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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.
Sites / Locations
- College of medical rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
study group
control group
Arm Description
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.
not receiving any exercises
Outcomes
Primary Outcome Measures
Health-related quality of life, Medical Outcomes Study short-form (SF-36)
assessed using the Short Form-36 (SF-36). The SF-36 scale had 8 dimensions, and each dimension was converted into a percentage score.
Health-related quality of life, Medical Outcomes Study short-form (SF-36)
assessed using the Short Form-36 (SF-36). The SF-36 scale had 8 dimensions, and each dimension was converted into a percentage score.
Respiratory function measurement
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).
Respiratory function measurement
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).
Secondary Outcome Measures
Chest expansion measurement
measured with a tape measure at 2 different levels of the rib cage. Measurements will be taken at the maximal inspiration and expiration
Chest expansion measurement
measured with a tape measure at 2 different levels of the rib cage. Measurements will be taken at the maximal inspiration and expiration
Exercise endurance measurement
measured by the 6-min walk test (6MWT), is the distance one walks within 6 min
Exercise endurance measurement
measured by the 6-min walk test (6MWT), is the distance one walks within 6 min
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05172102
Brief Title
Quality of Life and Lung Function on Post Covid-19 Patient
Acronym
Covid-19
Official Title
Effect of Breathing Exercise on Chest Expansion, Quality of Life and Lung Function on Post Covid-19 Patient: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Gaining a greater understanding of how the breathing exercise combined with aerobic and strengthening exercises will affects lung function and quality of life in post covid-19 persons
Detailed Description
this will improve exercise prescription guidelines relevant to this post covid-19. Therefore, the purpose of this work was determining the effect of breathing exercise combined with aerobic and strengthening exercises in improve chest expansion, lung function and quality of life in post covid-19 persons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
not receiving any exercises
Intervention Type
Other
Intervention Name(s)
breathing exercise, Aerobic exercises
Other Intervention Name(s)
resistance exercises
Intervention Description
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).
Primary Outcome Measure Information:
Title
Health-related quality of life, Medical Outcomes Study short-form (SF-36)
Description
assessed using the Short Form-36 (SF-36). The SF-36 scale had 8 dimensions, and each dimension was converted into a percentage score.
Time Frame
at baseline
Title
Health-related quality of life, Medical Outcomes Study short-form (SF-36)
Description
assessed using the Short Form-36 (SF-36). The SF-36 scale had 8 dimensions, and each dimension was converted into a percentage score.
Time Frame
after 6 weeks
Title
Respiratory function measurement
Description
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).
Time Frame
at baseline
Title
Respiratory function measurement
Description
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).
Time Frame
after 6 weeks
Secondary Outcome Measure Information:
Title
Chest expansion measurement
Description
measured with a tape measure at 2 different levels of the rib cage. Measurements will be taken at the maximal inspiration and expiration
Time Frame
at baseline
Title
Chest expansion measurement
Description
measured with a tape measure at 2 different levels of the rib cage. Measurements will be taken at the maximal inspiration and expiration
Time Frame
after 6 weeks
Title
Exercise endurance measurement
Description
measured by the 6-min walk test (6MWT), is the distance one walks within 6 min
Time Frame
at baseline
Title
Exercise endurance measurement
Description
measured by the 6-min walk test (6MWT), is the distance one walks within 6 min
Time Frame
after 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar Mahmoud, PhD
Organizational Affiliation
Qassim University
Official's Role
Study Director
Facility Information:
Facility Name
College of medical rehabilitation
City
Buraidah
State/Province
Qassim
ZIP/Postal Code
2100
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sets generated during and/or analyzed during the current study is available from the corresponding author on reasonable request.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
Citations:
PubMed Identifier
32379637
Citation
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.
Results Reference
result
PubMed Identifier
30154127
Citation
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.
Results Reference
result
PubMed Identifier
31499605
Citation
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.
Results Reference
result
Learn more about this trial
Quality of Life and Lung Function on Post Covid-19 Patient
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