The basic purpose of this study is to assess the effectiveness of upper limb exercise along with diaphragmatic breathing with or without lower limb exercise in COVID-19 survivors
Design
Single blinded, randomized, total sample size is 176 and each groups contain 88 participants by lottery method.
Settings and conduct
conducted at khawaja farid hospital
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Aged 35 and 60 years; male and female; COVID-19 survivors discharged from the hospital six weeks ago (diagnosed with COVID-19, respiratory illness)
Exclusion Criteria: having any of the following symptoms in the last 14 days: fever; new or worsening respiratory
symptoms; > 38.2 degrees Celsius (e.g., cough, dyspnea); Pregnant Females; Refusal to give consent approval.
Intervention groups
group A received upper limb exercise along diaphragmatic breathing while group B received upper limb exercise along diaphragmatic breathing with or without lower limb exercise in COVID-19 survivors
Main outcome variables
Respiratory function, exertion, quality of life
General information
Reason for update
Acronym
interventional
IRCT registration information
IRCT registration number:IRCT20220606055084N1
Registration date:2022-06-26, 1401/04/05
Registration timing:retrospective
Last update:2022-06-26, 1401/04/05
Update count:0
Registration date
2022-06-26, 1401/04/05
Registrant information
Name
Anam Zulfiqar
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences
Country
Pakistan
Phone
+92 336 6389053
Email address
anamzulfiqar@mimas.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-15, 1400/08/24
Expected recruitment end date
2021-12-15, 1400/09/24
Actual recruitment start date
2021-11-15, 1400/08/24
Actual recruitment end date
2021-12-20, 1400/09/29
Trial completion date
2022-02-02, 1400/11/13
Scientific title
Effectiveness of upper limb exercise along diaphragmatic breathing with or without lower limb exercise in covid-19 survivors
Public title
Effectiveness of exercise along with diaphragmatic breathing in covid-19 survivors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Between the ages of 35-60 years
Both male and female
COVID-19 survivors;
Discharged from the hospital six weeks ago (diagnosed with COVID-19, with respiratory illness)
Exclusion criteria:
Any of the following: fever; new or worsening respiratory symptoms > 38.2 degrees Celsius (e.g., cough, dyspnea) in the last 14 days,
Pregnant females
Refusal to give consent approval.
Age
From 36 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
176
More than 1 sample in each individual
Number of samples in each individual:
88
Each group consists of 88 participants.
Actual sample size reached:
176
More than 1 sample in each individual
Actual sample size in each individual:
88
Each group consists of 88 participants
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation concealment occur and patients will be recruited by using simple randomization through lottery method. Lottery method carried out through sealed envelops. Every participants will randomly choose the sealed envelop and open this sealed envelop.
Blinding (investigator's opinion)
Single blinded
Blinding description
Those participants will be unaware of the method of treatment that will be evaluated after the completion of the interventional trial. Subjects will be given the option of choosing between two samples. Both the samples are in the same packing. In one sample, upper limb exercise was performed alongside diaphragmatic breathing exercise in one sample, and lower limb exercise was performed alongside diaphragmatic breathing in the other two samples. Subjects will be completely unaware of the type and effect of both interventions.
Placebo
Used
Assignment
Parallel
Other design features
Borg Scale, spirometry, 6-minutes walk test and SF8 questionnaire was used to assess the patients before and after treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional ethical committee of Muhammad institute of medical and allied science Multan
Street address
HBL street near sabzazar metro station busan road, Multan
City
Multan
Postal code
60700
Approval date
2021-09-18, 1400/06/27
Ethics committee reference number
2021/IRB/10/PT/17
Health conditions studied
1
Description of health condition studied
corona virus
ICD-10 code
U07.1
ICD-10 code description
Covid-19, virus identified
Primary outcomes
1
Description
Respiratory function
Timepoint
before and after treatment(4 week duration)
Method of measurement
brog scale, spirometry, 6-minutes walk test and SF8 questionnaire
Secondary outcomes
1
Description
Endurance
Timepoint
Before and after treatment(4 week duration)
Method of measurement
borg scale, spirometry, 6-minutes walk test and SF8 questionnaire
Intervention groups
1
Description
Intervention group: group A received upper limb exercise along diaphragmatic breathing for 4 week (5 session per week)
Category
Treatment - Other
2
Description
Intervention group: Group B received upper limb along diaphragmatic breathing with lower limb exercise for 4 week( per week 5 session)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khawja Fareed hospital
Full name of responsible person
Farah Zahid
Street address
HBL street near Sabsazar metro station, Busan road, Multan
City
Multan
Postal code
60700
Phone
+92 336 6389053
Email
anamzulfiqar049@gmail.com
Web page address
http://mimas.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences
Full name of responsible person
Farah Zahid
Street address
HBL street near Sabzazar metero station, Bosan road, Multan
City
Multan
Postal code
60700
Phone
+92 336 6389053
Email
anamzulfiqar@gmail.com
Web page address
http://mimas.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Institute of Medical and Allied Sciences
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
Muhammad institute of medical and allied sciences, Multan
Full name of responsible person
Dr. Zahid Manzoor
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
HBL street Sabzazar, Bosan road, Multan
City
Multan
Province
Punjab
Postal code
60700
Phone
+92 336 6389053
Email
anamzulfiqar049@gmail.com
Web page address
http://mimas.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Muhammad institute of medical and allied sciences, Multan
Full name of responsible person
Farah Zahid
Position
professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
HBL street sabzazar metro station bosan road multan
City
Multan
Province
Punjab
Postal code
60700
Phone
+92 336 6389053
Email
anamzulfiqar049@gmail.com
Web page address
http://mimas.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
Muhammad institute of medical and allied sciences Multan
Full name of responsible person
Farah Zahid
Position
professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
HBL street near sabzazar metro station bosan road multan
City
Multan
Province
Punjab
Postal code
60700
Phone
0366389053
Email
anamzulfiqar@gmail.com
Web page address
http://mimas.edu.pk/
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
Effectiveness of upper limb exercise along diaphragmatic breathing with or without lower limb exercise in COVID-19 survivors
When the data will become available and for how long
this will be available at the end of 2022
To whom data/document is available
Farah zahid
Under which criteria data/document could be used
for reserach purpose
From where data/document is obtainable
https://www.researchgate.net/
What processes are involved for a request to access data/document
open assess
Comments
I want randomized clinical trial registration, please provide me as soon as possible so that i can continue my study