Protocol summary

Study aim
The effect of respiratory and peripheral muscles training on pulmonary and physiological performance in COVID-19 patient
Design
Clinical trial with control group, with parallel groups, randomized, on 36 patients. In order to randomize, a simple randomization method using a table of random numbers was used.
Settings and conduct
All patients who meet the inclusion criteria and have completed the consent form to participate in the project are invited to participate in the test. The tests include tests related to pulmonary function and CBC test. After the tests, the patients are randomly divided into three groups. In the first group, breathing exercises such as diaphragmatic breathing and pursed-lip breathing are performed. In the second group, breathing, muscle, balance, aerobic and stretching exercises are given. In the third group, they have no training during the intervention period. Patients do exercises for 6 weeks. Then the tests are repeated again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pneumonia confirmed by Pulmonologist (having signs and radiographic evidence of pneumonia); stable clinical condition regular participation in the treatment process (before participating in the research); being interested in participating in training courses. Non-entry criteria: pulmonary resection; neurological disease; mental illness; COPD disease; history of orthopedic and neurological disease that prevents exercise; uncontrolled blood pressure; cardiovascular disease; pregnancy and breastfeeding status.
Intervention groups
Respiratory muscle training group: six weeks of training, two sessions per week, 1 hour per session. Peripheral muscle training group: six weeks of training, two sessions per week, 1 hour per session. Control group: not doing any sports and training activities during the intervention period.
Main outcome variables
Pulmonary function; physiologic variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230305057618N1
Registration date: 2023-03-14, 1401/12/23
Registration timing: prospective

Last update: 2023-03-14, 1401/12/23
Update count: 0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Hossein Nabavinik
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 935 355 2864
Email address
hossein.nabavinik@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-19, 1401/12/28
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of respiratory and peripheral muscles training on pulmonary and physiological performance in COVID-19 patient
Public title
The effect of respiratory and peripheral muscles training on pulmonary and physiological performance in COVID-19 patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pneumonia confirmed by Pulmonologist (having signs and radiographic evidence of pneumonia) Stable clinical condition regular participation in the treatment process (before participating in the research) Being interested in participating in training courses
Exclusion criteria:
Pulmonary resection Neurological disease Mental illness COPD disease A history of orthopedic and neurological disease that prevents exercise Uncontrolled blood pressure Cardiovascular disease Pregnancy and breastfeeding status
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the table of random numbers, the patients included in the study will receive random numbers. By receiving codes 1, 2, 3, etc., they are placed in each of the three treatment groups. By receiving the number 1 (4, 7, 10, etc.), it enters group one. At first, he enters the pre-test stage and then begins the respiratory muscles training . By receiving code 2 (5, 8, 11, etc.), it is placed in the second group. They enter the pre-test stage. Then they participate in the peripheral muscles training . By receiving code 3 (6, 9, 12, etc.), it is placed in the third group (control). They enter the pre-test stage. They then continue to study. The treatment starts with the main therapist, but the results and interpretation are the responsibility of the people who are blind to the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Baqiyatallah Hospital
Street address
Sheikh Bahai St., Mulla Sadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-02-27, 1401/12/08
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.133

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Respiratory volumes
Timepoint
Before and after the intervention
Method of measurement
Plethysmography system

2

Description
Maximal inspiratory mouth pressures
Timepoint
Before and after the intervention
Method of measurement
Plethysmography system

3

Description
Maximal expiratory mouth pressures
Timepoint
Before and after the intervention
Method of measurement
Plethysmography system

4

Description
Maximal Voluntary Ventilation
Timepoint
Before and after the intervention
Method of measurement
Plethysmography system

5

Description
Diffusing capacity for carbon monoxide
Timepoint
Before and after the intervention
Method of measurement
Plethysmography system

6

Description
Ratio diffusing capacity for carbon monoxide to Alveolar Volume (DLCO/VA)
Timepoint
Before and after the intervention
Method of measurement
Plethysmography system

Secondary outcomes

1

Description
Red Blood Cell Count or RBC
Timepoint
Before and after the intervention
Method of measurement
CBC blood test

2

Description
White Blood Cell Count or WBC
Timepoint
Before and after the intervention
Method of measurement
CBC blood test

3

Description
Percentage of red blood cells in a blood or Hematocrit (HCT)
Timepoint
Before and after the intervention
Method of measurement
CBC blood test

4

Description
White Blood Cell Count or WBC
Timepoint
Before and after the intervention
Method of measurement
CBC blood test

5

Description
Count measures the platelet level in blood or Plt
Timepoint
Before and after the intervention
Method of measurement
CBC blood test

Intervention groups

1

Description
Intervention group 1- Respiratory muscle training: They participate in a six-week training period. In addition to breathing training, these exercises include diaphragmatic breathing exercises, pursed lip breathing exercises, cough exercises, and stretching exercises. Exercises are done twice a week for one hour at home. Supervision of exercises is done through video and social networks.
Category
Rehabilitation

2

Description
Intervention group 2- Peripheral muscle training: They participate in a six-week training period. This course includes breathing, muscle, balance, aerobic and stretching exercises. Exercises are done twice a week for one hour at home. Exercises are done at home. Supervision of exercises is done through video and social networks.
Category
Rehabilitation

3

Description
Control group: The test group is asked not to participate in any exercise program during the research period and to continue their daily diet and to report any changes such as illness, stress, etc.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Mashhad Hospital
Full name of responsible person
Hossein Nabavinik
Street address
No. 43, Saadat 13, 23 Pyamber Azam Highway, Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9198734136
Phone
+98 51 3521 7686
Email
Hossein.nabavinik@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
AbbasAli Imani Fooladi
Street address
Vanak Square, Mulla Sadra St., Sheikh Bahai St., Shahid Nusrati Alley., Baqiyatullah University.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
imanifouladi.a@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Vahid Sobhani
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Vanak Square, Mulla Sadra St., Sheikh Bahai St., Baqiyatullah University, Sports Physiology Research Center
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4391
Email
sobhani518@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hossein Nabavinik
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Biomechanics
Street address
Sports Physiology Research Center, Baqiyatullah University, Sheikh Bahai St., Mulla Sadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4391
Fax
Email
hossein.nabavinik@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hossein Nabavinik
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Biomechanics
Street address
Sports Physiology Research Center, Baqiyatullah University, Sheikh Bahai St., Mulla Sadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4391
Fax
Email
hossein.nabavinik@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Clinical trial data will be published as an article
When the data will become available and for how long
6 months after results are published, access begins
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Related scientific research
From where data/document is obtainable
Sports Physiology Research Center, Baqiyatullah University.
What processes are involved for a request to access data/document
Approved research plan documents
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