The aim of the study was to assess the potential of the drug nebivolol on the cardiorespiratory parameters against exercise-induced stress and its related complications.
Design
200 patients were randomized into the control group(100) and treatment group(100) by simple randomization. It was a single-blinded randomized controlled trial. In this study participants will be completely blinded about intervention protocol.
Settings and conduct
Muhammad physical therapy and rehabilitation center, KAIMS institute, Times university
200 patients were randomized into the control group(100) and treatment group(100) by simple randomization. It was a single-blinded randomized controlled trial. In this study, participants will be completely blinded by the intervention protocol.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 18-25 years of age, mentally and physically fit, healthy individuals.
Exclusion criteria: lactating mother, pregnant females, surgery, trauma
Intervention groups
Group 1 was an exercise group that performed only stress-induced exercises
Group 2 was the medicine group that performed the stress-induced exercises with the medicine
Main outcome variables
Blood pressure, Respiration rate, Heart rate, Oxygen saturation, Temperature, Quality of life, and endurance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220603055064N1
Registration date:2022-06-30, 1401/04/09
Registration timing:registered_while_recruiting
Last update:2022-06-30, 1401/04/09
Update count:0
Registration date
2022-06-30, 1401/04/09
Registrant information
Name
Alisha Rehman
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences Multan
Country
Pakistan
Phone
+92 311 6800976
Email address
alisharehman@mimas.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2022-08-31, 1401/06/09
Actual recruitment start date
2022-06-25, 1401/04/04
Actual recruitment end date
2022-08-31, 1401/06/09
Trial completion date
2022-08-31, 1401/06/09
Scientific title
Effects of nebivolol on the cardiorespiratory parameters against exercise-induced stress in female physiotherapy students
Public title
Effects of nebivolol on the cardiorespiratory parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy female students
Mentally and physically fit
Normal BMI
Age 18-25
Exclusion criteria:
Menstruations period
Pregnant females
Lactating mother
Cardiac and respiratory issues
Surgery
Trauma
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
200
More than 1 sample in each individual
Number of samples in each individual:
100
100 participant in each group
Actual sample size reached:
200
More than 1 sample in each individual
Actual sample size in each individual:
100
100 participants in each group
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomized into two groups by using a convenient sampling technique. Subjects were randomized by lottery method (Draw numbers from the box randomly to choose samples).
Blinding (investigator's opinion)
Single blinded
Blinding description
participants were blinded they were unaware of the type and effects of intervention protocol they were also completely blinded to what will happen to them after exercise but consent forms were given to all participants and explained the study protocol. two samples were taken with the same packings. in one sample conventional drugs (tablets) with no effects and exercise protocols were given to control group participants and in another sample nebivolol drugs (nebivolol) with exercise protocol were given to the intervention group participants (Group 2). Remember participants were completely unaware which drug they have take either conventional drug with no effects or nebivolol with effects
Placebo
Not used
Assignment
Parallel
Other design features
Subjects included in this study by filling QOL questionnaire and PAR-Q
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Street address
HBL street, near sabzazar metro station, bosan road Multan
City
Multan
Postal code
60700
Approval date
2021-09-18, 1400/06/27
Ethics committee reference number
2021/IRB/08/PT/10
Health conditions studied
1
Description of health condition studied
healthy
ICD-10 code
Z76.3
ICD-10 code description
Healthy person accompanying sick person
Primary outcomes
1
Description
Blood pressure
Timepoint
Participants were evaluated before and after giving medicine (Nebivolol)
Intervention group: group 2 will be given nebivolol drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Muhammad institute of medical and allied sciences Multan
Full name of responsible person
Dr. Umber Batool
Street address
HBL street, near sabzazar metro station, Bosan road
City
Multan
Postal code
60700
Phone
+92 311 6800976
Email
ambersafdar06@gmail.com
Web page address
http://mimas.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Muhmmad institute of medical and allied sciences
Full name of responsible person
Dr. Imran Ahmad Khan
Street address
HBL street, near sabzazar metro station, bosan road
City
Multan
Postal code
60700
Phone
+92 311 6800976
Email
imranahmadkhandurrani@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?
No
Title of funding source
Muhmmad 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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences Multan
Full name of responsible person
Umber Batool
Position
Senior Lecturer
Latest degree
Specialist
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
+92 311 6800976
Email
ambersafdar06@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
Imran Ahmad Khan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Cardiology
Street address
HBL streert, near sabzazar metro station, Bosan road multan
City
Multan
Province
Punjab
Postal code
60700
Phone
+92 311 6800976
Email
imranahmadkhandurrani@gmail.com
Web page address
http://mimas.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Muhmmad institute of medical and allied sciences
Full name of responsible person
Dr. Umber Batool
Position
Senior Lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
HBL street, near sbzazar metro station, Bosan road
City
Multan
Province
Punjab
Postal code
60700
Phone
+92 311 6800976
Email
yousafqasmi7@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
Title of my study effect of nebivolol on the cardiorespiratory parameters against exercise-induced stress in female physiotherapy students in Multan. The basic purpose of my study was to assess the potential of the drug nebivolol on the cardiorespiratory parameters. A randomized controlled trial was conducted at Muhammad institute of medical and allied sciences Multan. 200 participants were selected who met the inclusion criteria will be randomized into two groups, Control group (1) and treatment Group (2). Convenient sampling technique used in it. Group 1 in which the stress induced exercises performed and Group 2 in which the drug nebivolol used.
When the data will become available and for how long
This is expected that this study or data will be available at the end of this year 2022. no exact date can be expected.