The purpose of this study is to investigate the effect of combined exercise in water on blood cell count, physical performance, body composition and quality of life of elderly men.
Design
A randomized clinical trial with an intervention group and control group with parallel groups on 40 elderly people aged 60 to 75 years, which writing the names on papers and lottery will be used for randomization.
Settings and conduct
This study will be conducted with the approach of improving immune function, physical function, body composition and quality of life of elderly men in Shahrekord city. 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 Martyrs' Pool of Shahrekord city.
Participants/Inclusion and exclusion criteria
Elderly people without special diseases and capable of doing exercise, confirmed by a general physician, not suffering from any known cardiovascular diseases and blood pressure disorders, as well as not having movement problems or any clinical conditions that can limit doing exercise will be selected.
Criteria for not entering the study is inflecting cardiovascular and hematological disorders, as well as motor and cognitive problems.
Intervention groups
The first group is the water training group that will implement the set protocol and the second group is the control group.
Main outcome variables
Complete blood count, physical performance, body composition and quality of life
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20200408046997N2
Registration date:2024-01-17, 1402/10/27
Registration timing:registered_while_recruiting
Last update:2024-01-17, 1402/10/27
Update count:0
Registration date
2024-01-17, 1402/10/27
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
2024-01-13, 1402/10/23
Expected recruitment end date
2024-02-03, 1402/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of combined aqua-exercise on complete blood count, physical performance, body composition and quality of life of elderly men
Public title
Investigating the effect of combined aqua-exercise on health and physical performance of elderly men
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Males aged 60 to 75
Not having contraindication to do exercise
Not doing 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
Male
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
2023-09-26, 1402/07/04
Ethics committee reference number
IR.SHAHED.REC.1402.071
Health conditions studied
1
Description of health condition studied
Elderly people
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Complete blood count
Timepoint
Before and after
Method of measurement
Photometric method
2
Description
Physical performance
Timepoint
Before and after
Method of measurement
senior fitness test
3
Description
body composition
Timepoint
Before and after
Method of measurement
Body composition َAnalyzer
4
Description
Quality of life
Timepoint
Before and after
Method of measurement
Using SF-36 questionnaire
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before and after
Method of measurement
Sphygmomanometer
2
Description
blood oxygen
Timepoint
Before and after
Method of measurement
Oximeter
3
Description
Lipid profile
Timepoint
Before and after
Method of measurement
Photometric method
4
Description
weight
Timepoint
Before and after
Method of measurement
Scale
5
Description
Body mass index
Timepoint
Before and after
Method of measurement
Scale and stadiometer
Intervention groups
1
Description
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
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
Shohada pool
Full name of responsible person
Ebrahim Shafeghat
Street address
North Hafez street
City
Shahre Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813776775
Phone
+98 38 3222 4995
Email
reza.karimzadeh7619@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 Holy shrine of Imam Khomeini, Persian Gulf Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15875-5794
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
Reza Karim Zadeh Rostami
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Exercise Physiology
Street address
Shahed University, opposite Holy shrine of Imam Khomeini, Persian Gulf Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15875-5794
Phone
+98 21 5121 2456
Fax
+98 21 5121 2456
Email
reza.karimzadeh7619@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
Shahed University, Opposite the Holly Shrine of Imam Khomeini, Persian Gulf Highway (Tehran-Qom), Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15875-5794
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 to the Holly Shrine of Imam Khomeini, Persian Gulf Highway (Tehran-Qom), 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