The aim of this study is to determine effectiveness of diaphragmatic stretching for improving pulmonary function, exercise tolerance and quality of life in Covid 19 survivors
Design
Quasi experimental study design
Settings and conduct
Subjects are single blinded
Participants/Inclusion and exclusion criteria
COVID-19 survivors (i.e., diagnosed with COVID-19, have had respiratory illness and discharged from the hospital 6 weeks ago)
Aged 35 years or above
Gender (Male and Female)
No medical diagnosis of psychiatric illness
Stated willingness to comply with all study procedures and availability for the duration of the study
Ability of participant to understand and the willingness to sign a written informed consent document.
Hemoglobin of 9.0 gm/dl or higher
COVID-19 Survivor Group documented prior COVID-19 as evidenced by:
At least 6 weeks ago since onset of COVID-19 symptoms and no fever for at least 1 week.
Participants were excluded if they exhibited.
Any person who experienced any back pain or who had experienced any type of illness in the past week were excluded from the study.(35)
History of any of the following in the past 14 days: fever > 38.2 degrees Celsius; new or worsening respiratory symptoms (e.g. cough, dyspnea).
Subjects were also excluded if they had received any manual therapy within the previous month.(35)
Pregnancy
Refusal to give consent
Intervention groups
Single group
Main outcome variables
Spirometry
6MWT
Borg Scale
SF8 questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211224053506N1
Registration date:2022-01-19, 1400/10/29
Registration timing:retrospective
Last update:2022-01-19, 1400/10/29
Update count:0
Registration date
2022-01-19, 1400/10/29
Registrant information
Name
Hafiza Syeda Farah Zahid
Name of organization / entity
Ripah international university lahore
Country
Pakistan
Phone
+92 310 6238453
Email address
farahzahid977@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-10, 1400/04/19
Expected recruitment end date
2021-12-25, 1400/10/04
Actual recruitment start date
2021-08-05, 1400/05/14
Actual recruitment end date
2021-11-12, 1400/08/21
Trial completion date
2022-02-25, 1400/12/06
Scientific title
Effects of a Diaphragmatic Stretching on Pulmonary Functions, Exercise Tolerance and Quality's of Life in Covid-19 Survivors
Public title
Effect of stretching exercise of diaphragm on lung function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 survivors (i.e., diagnosed with COVID-19, have had respiratory illness and discharged from the hospital 6 weeks ago) No medical diagnosis of psychiatric illnessStated willingness to comply with all study procedures and availability for the duration of the studyAbility of participant to understand and the willingness to sign a written informed consent document.Hemoglobin of 9.0 gm/dl or higherCOVID-19 Survivor Group documented prior COVID-19 as evidenced by:At least 6 weeks ago since onset of COVID-19 symptoms and no fever for at least 1 week.
Aged 35 years or above. Gender (Male and Female)
Exclusion criteria:
Participants were excluded if they exhibited.Any person who experienced any back pain or who had experienced any type of illness in the past week were excluded from the study.(35)History of any of the following in the past 14 days: fever > 38.2 degrees Celsius; new or worsening respiratory symptoms (e.g. cough, dyspnea).Subjects were also excluded if they had received any manual therapy within the previous month.(35)Pregnancy Refusal to give consent
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
53
Actual sample size reached:
53
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
No
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Riphah International University
Street address
qasoori chowk near jinnah chowk multan
City
lahore
Postal code
66000
Approval date
2021-07-03, 1400/04/12
Ethics committee reference number
022948
Health conditions studied
1
Description of health condition studied
Covid 19 survivors
ICD-10 code
B97.2
ICD-10 code description
Coronavirus as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Spirometry
Timepoint
1st week, 9th week, 18th week of treatment
Method of measurement
spirometer
Secondary outcomes
1
Description
6 minute walk test
Timepoint
1st week, 9th week and 18th week of treatment
Method of measurement
walk test
Intervention groups
1
Description
Intervention group:
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khawaja farid hospital multan
Full name of responsible person
Dr.Shazia
Street address
qasoori chowk near jinnah chowk multan
City
lahore
Postal code
66000
Phone
+92 61 6223119
Email
farahzahid977@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah international university
Full name of responsible person
Dr.Shakeel
Street address
qasoori chowk near jinnah chowk multan
City
lahore
Postal code
66000
Phone
+92 61 6223119
Email
farahzahid977@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah international university
Proportion provided by this source
100
Public or private sector
Private
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
Riphah international university
Full name of responsible person
Dr.Shakeel
Position
head of department
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
qasoori chowk near jinnah chowk multan
City
lahore
Province
Punjab
Postal code
66000
Phone
+92 61 6223119
Email
farahzahid977@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Qurat ul ain
Position
professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
qasoori chowk near jinnah chowk multan
City
lahore
Province
Punjab
Postal code
66000
Phone
+92 61 6223119
Email
farahzahid977@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Farah zahid
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
qasoori chowk near jinnah chowk multan
City
lahore
Province
Punjab
Postal code
66000
Phone
+92 61 6223119
Email
farahzahid977@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available