Aim of this study is to intervent the change in (blood pressure, pulse rate, oxygen saturation, glucose level, lipid profile ,uric acid level, HDL, LDL temperature respiration rate and C-reactive protein ) to see level of improvement of the quality of life and to prevent from cardiovascular abnormalities in young adults of Multan with hyperlipidemia that are associated with body mass index and cardiorespiratory and cardiometabolic fitness.
Design
Randomized , single group design with triple blinded study
Settings and conduct
MIMAS, Faiz hospital and Shahbaz Sharif
Participants/Inclusion and exclusion criteria
• Young Adults.
• Age group of 18-30 years.
• Hyperlipidemic people.
• Mentally and physically wellbeing.
The excluding criteria:
• Older Adults.
• Childs.
• Pregnant Women.
• Uncontrolled hypertension.
• Chronic heart problems.
• Physically disable.
• Mentally ill.
• Any type of major surgery.
• Lactating females.
Intervention groups
Group 1 with jogging exercise , group 2 with brisk walking and group 3 with jumping rope exercise
Main outcome variables
improvement in crf and CMP
General information
Reason for update
Acronym
cross sectional experimental study
IRCT registration information
IRCT registration number:IRCT20230718058826N4
Registration date:2024-01-03, 1402/10/13
Registration timing:retrospective
Last update:2024-01-03, 1402/10/13
Update count:0
Registration date
2024-01-03, 1402/10/13
Registrant information
Name
Perwasha Perwasha
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Country
Pakistan
Phone
+92 310 6562039
Email address
perwashanaseer123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-29, 1402/05/07
Expected recruitment end date
2023-09-29, 1402/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of aerobic exercises on cardiorespiratory and cardiometabolic fitness in hyperlipidemic young population of Multan
Public title
Assessing the effect of aerobic exercises on cardiorespiratory and cardiometabolic fitness in hyperlipidemic young population of Multan
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
• Young Adults.•
Age group of 18-30 years
Hyperlipidemic people.•
.• Mentally and physically wellbeing.
Exclusion criteria:
• Older Adults.•
Childs.•
Pregnant Women.•
Uncontrolled hypertension.•
Chronic heart problems.•
Physically disable.•
Mentally ill.•
Any type of major surgery.•
Lactating females.
Age
From 18 years old to 30 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
393
More than 1 sample in each individual
Number of samples in each individual:
131
in 3 groups, 131, 131 participants will be added for inducing the stress by using stress inducers
Randomization (investigator's opinion)
Randomized
Randomization description
we are studying randomized control trial allocation done by lottery method in which 393 patients or participants divided into 3 groups randomly with 131 participants each in each group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
in this study, triple blinding method involved in which the participants, investigator and data analyzer will be blinded. Participant do not know about exercise, investigator randomly allocate the patient or participants and data analyzer will be independent for results.
Placebo
Not used
Assignment
Single
Other design features
Randomized control trial will be used in this study. We will randomly allocate the patients into 3 different interventional groups. Each group contain 131 participants.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
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
66000
Approval date
2023-07-10, 1402/04/19
Ethics committee reference number
2023/ MIMAS/Sawera/08/19
Health conditions studied
1
Description of health condition studied
cardiometabolic and cardiorespiratory fitness health in young adults of Multan with hyperlipidemia
ICD-10 code
E00-E89
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
Decrease cholestrol level and improve the cardiorespiratory health
Timepoint
Time duration of study will be 8 weeks .5 days a week for 8 weeks.
Method of measurement
digital sphygmomonometer, thermometer, pulse oximeter, lab kit to measure blood glucose, cholesterol and uric acid
Secondary outcomes
empty
Intervention groups
1
Description
'Intervention group' 1 with jogging .Drink 1 glass of water every hour until you run so you are hydrated. Start with 5 mins of exercise in start and then build up at least 10 mins per session. The goal will be to achieve at least 65-70 mins of jogging per week. Make sure you warm and stretch thoroughly before the exercise. Heart rate , blood pressure, respiration rate, oxygen saturation and temperature will be recorded before and after the exercise. (21)
Category
Lifestyle
2
Description
Intervention group: ‘Internationale group 2’ with brisk walking .This analysis will be done in young overweight/obese people who completed either the brisk walking program or the brisk walking plus diet program. The brisk walking consisted of walking for 5 to 10 minutes per session and for 3 to 6 days/week. The diet consisted of 60 minutes of group education and 15 to 20 minutes of individual counselings every week. Heart rate, respiration rate ,blood pressure, oxygen saturation and temperature will be recorded before and after the exercise. (22)
Category
Lifestyle
3
Description
Intervention group: ‘Intervention group 3’ with jumping rope. Exercise intervention will be designed as individualised rope skipping 20 per session and three times a week. The participants will be instructed to gradually increase the amount of rope skipping to 150 per week and then they maintain this exercise intensity until the end of the intervention. Heart rate ,respiration rate, blood pressure ,oxygen saturation and temperature will be recorded before and after the exercise. (23)
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Faiz hospital
Full name of responsible person
Nimra Arif
Street address
BCG chock
City
multan
Postal code
66000
Phone
+92 321 6563479
Email
nimraarif@gmail.com
2
Recruitment center
Name of recruitment center
Shahbaz Sharif hospital
Full name of responsible person
ali abbas
Street address
Fawara chock
City
multan
Postal code
66000
Phone
+92 321 5654897
Email
shahbaz@gmail.com
Web page address
3
Recruitment center
Name of recruitment center
MIMAS, Multan
Full name of responsible person
Imran Ahmad Khan
Street address
HBL street near sabzazar metro station bosan road Multan
City
multan
Postal code
66000
Phone
+92 333 6120602
Email
imranahmadkhandurrani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CUVAS
Full name of responsible person
Zahid Manzoor
Street address
bahawalpur , punjab, Pakistan
City
Bahawalpur
Postal code
63100
Phone
+92 312 6678543
Email
zahidmanzoor@cuvas.edu.pk
Grant name
scholarship for research
Grant code / Reference number
43681
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
scholarship for research
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
CUVAS
Full name of responsible person
Zahid Manzoor
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
bahawalpur , punjab, Pakistan
City
Bahawalpur
Province
punjab
Postal code
63100
Phone
+92 312 6678543
Email
zahidmanzoor@cuvas.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
MIMAS
Full name of responsible person
Perwasha
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
HBL street near sabzazar metro station bosan road Multan
City
multan
Province
Punjab
Postal code
66000
Phone
+92 310 6562039
Email
perwashanaseer123@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
MIMAS
Full name of responsible person
Perwasha
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
HBL street near sabzazar metro station bosan road Multan
City
multan
Province
punjab
Postal code
66000
Phone
+92 310 6562039
Email
perwashanaseer123@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
Aim of this study is to explore the correlation of (blood pressure, pulse rate, oxygen saturation, glucose level, lipid profile, temperature and respiration rate) and to improve the quality of life in young adults of Multan with hyperlipidemia that are associated with body mass index and cardiorespiratory and cardiometabolic health.
1.6. Expected outcomes
This study will investigate the correlation of cardiorespiratory and cardiometabolic fitness with body mass index in young adults of Multan with hyperlipidemia. We will expect a positive result with blood pressure, heart rate, respiration rate, temperature and oxygen saturation and negative result with VO2max and cholesterol level.
When the data will become available and for how long
after practical completion
To whom data/document is available
investigator
Under which criteria data/document could be used
under ethical consideration
From where data/document is obtainable
secretary BASR
What processes are involved for a request to access data/document