Investigating the effect of combined aquatic training on motor performance, metabolic health and quality of life of overweight elderly women
Design
A randomized trial with an intervention group and control group with parallel groups on 40 elderly people aged 60 to 75 years. Block randomization will be used for the allocation of the participants to study groups.
Settings and conduct
This study will be conducted with the approach of improving motor performance, metabolic health and quality of life of overweight elderly women in Tehran. After checking and being eligible to enter the study, 40 people will be selected and trained for 8 weeks (according to the sports protocol designed by the researcher) in the pool Yas of Neshat village in Tehran
Participants/Inclusion and exclusion criteria
Elderly women with an age of 60 to 75 years who are overweight (based on body mass index criteria), not suffering from cardiovascular diseases and blood pressure, as well as not having motor disorders or any clinical conditions that can limit participating in exercise will be selected.
The exclusion criteria will be suffering from known cardiovascular disease, and/or metabolic, motor and cognitive disorders.
Intervention groups
The first group is the combined aquatic exercise group that will participate in the combined aquatic exercise protocol three times per week for 12 weeks, and the second group is the control group that subjects in this group will continue their normal life and will not participate in any regular exercise.
Main outcome variables
Motor performance , Metabolic health , Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200408046997N3
Registration date:2024-05-01, 1403/02/12
Registration timing:prospective
Last update:2024-05-01, 1403/02/12
Update count:0
Registration date
2024-05-01, 1403/02/12
Registrant information
Name
Ali Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 2456
Email address
a.samadi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-11, 1403/02/22
Expected recruitment end date
2024-06-06, 1403/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying effect of combined aquatic training on motor performance, metabolic health and quality of life of overweight elderly women
Public title
Combined aquatic exercise training in elderly women
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Females aged 60 to 75
Not having any medical contraindication to do moderate exercise
Not engaging in regular exercise in past 6 month
Exclusion criteria:
Having known cardiovascular disease
Having cognitive and metabolic disorder, such as diabetes
Not being able to do exercise because of musculoskeletal limitations
Age
From 60 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be assigned to the study groups, i.e., combined Aqua exercise group (A) and control group (B) using the block randomization method. First the size of each block and the number of blocks will be determined. Considering that the total sample size is 40, 10 blocks of 4 will be used and each block will be used for 4 subjects. Using Random Allocate Software random blocks of 4 with (A) and (B) letters will be created, and then the block number will be selected by lottery, and subjects 1 to 4 will be assigned to the combined aqua exercise group (A) or control group (B) based on the order of letters of the block. Rest of the subjects will be assigned to the combined aqua exercise group (A) or control group (B) in a similar manner.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed university, opposite to the Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2024-02-26, 1402/12/07
Ethics committee reference number
IR.SHAHED.REC.1402.136
Health conditions studied
1
Description of health condition studied
Elderly people
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Motor performance
Timepoint
Pre-test measurements will be done 24-48 hours before the first exercise session, and for the post-test 48 hours after the last exercise session.
Method of measurement
Senior fitness test
2
Description
Metabolic health
Timepoint
Assessment of metabolic health will be done 24-48 hours before the first exercise session, and 48 hours after the last exercise session.
Method of measurement
For metabolic health, a total of 5 cc blood will be taken from the antecubital vein, and the fasting blood sugar and lipid profiles will be assessed 24 to 48 hours before and 48 hours after the combined aquatic exercise protocol.
3
Description
Quality of life
Timepoint
Assessment of quality of life will be done 24-48 hours before the first exercise session, and 48 hours after the last exercise session.
Method of measurement
Using SF-36 questionnaire
Secondary outcomes
1
Description
Blood pressure
Timepoint
Assessment of blood pressure will be done 24-48 hours before the first exercise session, and 48 hours after the last exercise session.
Method of measurement
Digital sphygmomanometer
2
Description
Body composition
Timepoint
Assessment of body composition will be done 24-48 hours before the first exercise session, and 48 hours after the last exercise session.
Method of measurement
Through the assessment of waist circumference (WC) and body mass index (BMI)
Intervention groups
1
Description
Intervention group:After performing the pretests for both the combined aquatic exercise and control groups, the exercise group will complete the exercise program for 8 weeks (3 sessions pre week/ 60 minutes each session). All exercises will be done in water with the presence a researcher and an aqua exercise specialist. Each training session includes a 10-minute warm-up in the water (stretching movements and various types of walking in the water and a number of combined stretching and jumping exercises), 20 minutes of resistance exercises in the water for large and main muscle groups (strengthening the chest, thighs and arms) using traction and bouncy forces, along with stretching and aerobics exercises in water for 20 minutes (fast walking, jumping and performed combined with stretching movements and jumping to increase the heart rate) and 10 minutes of cooling down (including, light stretching movements and gentle walking in water).
Category
Rehabilitation
2
Description
Control group: During the study, the control group will have the usual daily physical activities and go through the normal daily lives and will not participate in any regular and purposeful exercise training program
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports complex of Neshat Village of Yas pool
Full name of responsible person
Faezeh Rajabi
Street address
First Roshan, East Firouzkoh , End of Shahid Fallahi Street, Zafaranieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1988774351
Phone
+98 938 077 8155
Email
faezehrajabi00603@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Shahriar Bijani
Street address
Shahed University, Opposite the Holly shrine of Imam Khomeini, Persian Gulf Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4110
Fax
+98 21 5121 4110
Email
info@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Faezeh Rajabi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Exercise Physiology
Street address
Shahed University, Opposite the Holy shrine of Imam Khomeini, Persian Gulf Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2456
Email
faezehrajabi00603@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Ali Samadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Sahed University, opposite Holy shrine of Imam Khomeini, Persian Gulf Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2456
Fax
+98 21 5121 2456
Email
a.samadi@shahed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Ali Samadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Shahed University, Opposite the Holly shrine of Imam Khomeini, Persian Gulf Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5253
Email
a.samadi@shahed.ac.ir
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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available