Exploring the effect of stress inducers aerobic exercises (stair climbing, 6MWT, step up)between BP, HR, oxygen saturation, glucose level, lipid profile, temperature, and RR estrogen and progesterone level of post-menopausal females of Multan with body mass index and cardiorespiratory and cardiometabolic health.
Design
Randomized control trial, three parallel groups design, triple blinded study with a sample size of 45
Settings and conduct
Shahbaz Sharif Hospital, Muhammad Rehabilitation center, Faiz hospital
Participants/Inclusion and exclusion criteria
Including Criteria: Females; Aged 40-60 years; Postmenopausal females; Good mental and physical health; Naturally menopausal females; Negative screening mammogram. Exclusion criteria: Young females; Perimenopausal females; Any type of physical disability; Any type of major surgery; Females with osteoporosis and osteoarthritis; History of melanoma or breast cancer; Females who have any type of hormone replacement therapy.
Intervention groups
3 groups of intervention are included in this study. group 1 with 6 minute walk test, group 2 with stair climbing exercise and group 3 with step up exercise
Main outcome variables
cardiorespiratory and cardiometabolic parameters improvement
General information
Reason for update
Acronym
cross sectional experimental study
IRCT registration information
IRCT registration number:IRCT20230718058826N3
Registration date:2023-09-01, 1402/06/10
Registration timing:registered_while_recruiting
Last update:2023-09-01, 1402/06/10
Update count:0
Registration date
2023-09-01, 1402/06/10
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
2023-09-14, 1402/06/23
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 post menopausal females in Multan
Public title
Assessing the effect of aerobic exercises on cardiorespiratory and cardiometabolic fitness in post menopausal females in Multan
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Females 40-60
post menopausal females
good mental and physical health
natural menopausal
negative screening mammogram
Exclusion criteria:
young females
perimenopausal
any type of physical and mental disability, major surgery
females with OP OA
history of melanoma or breast cancer
hormone replacement therapy patient
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation is done by the lottery method in which the names of the participants are written on pieces of paper and randomly chosen the paper by an individual and then people are allocated randomly to different groups without knowing which participant is added to which intervention 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. Participants randomly allocate in different intervention group and they do not know about exercise in any intervention group ,investigator randomly allocate the patient or participant and data analyzer will be independent for results.
Placebo
Not used
Assignment
Parallel
Other design features
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/Anosha/07/19
Health conditions studied
1
Description of health condition studied
cardiorespiratory and cardiometabolic health in post menopausal females age 40-60
ICD-10 code
ICD-10
ICD-10 code description
post menopausal females, cardiorespiratory fitness
Primary outcomes
1
Description
Improve Cardiorespiratory and cardiometabollic health
Timepoint
time duration of study will be six weeks. 5 days in a weak for 6 weeks
time duration of study will be 6 weeks. 5 days in a week for 6 weeks
Method of measurement
vo2max,cardiorespiratory parameters
Intervention groups
1
Description
"Intervention Group 1": with 6 Minute Walk Test (6MWT)A 30m walking pace will be decided. Subjects will be instructed to walk from end to end, while attempting to cover as much distance as possible in the 6 minutes. The time and distance covered will be recorded. The Borg scales for dyspnea and leg fatigue, as well as heart rate were recorded before and immediately after completion of the walk test(24). BP, HR, RR, temperature and oxygen saturation will be measured before and after the exercise.
Category
Lifestyle
2
Description
"Intervention Group 2": with Stair climbing3 bouts of stair climbing will be separated. In this, protocol will be included 3 daily bouts of ascending a 3-flight stairwell (10 steps) for 4 minutes gently without break. The height of step will be 35cm. This activity will be performed 5days/week for 6 weeks. BP, HR, RR, temperature and oxygen saturation will be measured before and after the exercise.
Category
Lifestyle
3
Description
'Intervention group 3": with Step up exercise3 sets with 10 repetitions in each set will be performed for 6 weeks. BP, HR, RR, temperature and oxygen saturation will be measured before and after the exercise.
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
imtanahmadkhandurrani@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
4531
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
Assistasnt 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 correlates(BP, HR, oxygen saturation, glucose level, lipid profile, temperature, RR) of post menopausal females of Multan that are associated with body mass index and cardiorespiratory and cardiometabollic health. Aim of this study is to improve the quality of life.
1.4. Expected Outcomes
This study will investigate the correlation of cardiorespiratory fitness and cardiometabolic with body mass index in post menopausal females of Multan and also investigate the respiratory improvements.
When the data will become available and for how long
After the protocol completion data will be available for long time
To whom data/document is available
Supervisor provided the all documents
Under which criteria data/document could be used
Under strict ethical consideration
From where data/document is obtainable
from secretary BASR
What processes are involved for a request to access data/document