The effect of aquatic exercise program on pain, dryness, motor function, happiness, body composition and hip circumference of elderly men with osteoarthritis of the knee
Evaluation of the effects of aquatic exercise program on pain, dryness, motor function, happiness, body composition and hip circumference in elderly men with knee osteoarthritis
Design
The sample size in this study was 40 people who were randomly divided into 2 experimental groups (aquatic exercise) and control group. 48 hours before and after the aquatic exercise, the Womak and Happiness questionnaires were filled out by both groups, and measurements of body composition and hip circumference were completed and analyzed by all subjects.
Settings and conduct
The participants of the experimental group start the aquatic exercise training program for 6 weeks under the supervision of the researcher (in the Kosar pool in Rasht). The water aquatic program was performed three times a week for 50 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Age over 65 years 2) Gender (Man) 3) Have a history of at least 6 months of knee osteoarthritis
Exclusion criteria: 1) Inability to perform aquatic exercises 2) Taking supplements and medications to reduce knee pain during the month before the study
Intervention groups
Aquatic exercise training group (20 people), control group (20 people)
Main outcome variables
Womak Questionnaire Indices (including pain, dryness, motor function) and Happiness Questionnaire, body mass index and hip circumference
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180503039517N10
Registration date:2021-04-07, 1400/01/18
Registration timing:prospective
Last update:2021-04-07, 1400/01/18
Update count:0
Registration date
2021-04-07, 1400/01/18
Registrant information
Name
Soleyman Ansari Kolachahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2906
Email address
solomonansari@phd.iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-14, 1400/01/25
Expected recruitment end date
2021-04-25, 1400/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aquatic exercise program on pain, dryness, motor function, happiness, body composition and hip circumference of elderly men with osteoarthritis of the knee
Public title
The effect of aquatic exercise program on pain, dryness, motor function, happiness, body composition and hip circumference of elderly men with osteoarthritis of the knee
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 65 years
Gender (Man)
Have a history of at least 6 months of knee osteoarthritis
Exclusion criteria:
Inability to perform aquatic exercises
Taking supplements and medications to reduce knee pain during the month before the study
Age
From 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
40 males with osteoarthritis of the knee will be selected by available sampling method.
Through a lottery (participants' names were written on paper and will be divided into experimental and control groups through random lottery)
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, responsible for collecting and processing the data, the type of intervention, and the participants in the research groups are unaware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Islamic Azad University, Rasht Branch
Street address
Islamic Azad University, Rasht Branch, Lakan Blv
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Approval date
2020-08-17, 1399/05/27
Ethics committee reference number
IR.IAU.RASHT.REC.1399.036
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Womak Questionnaire Indicators (including pain, dryness, motor function)
Timepoint
48 hours before and after the exercise intervention
Method of measurement
WOMAC Questionaire
2
Description
Happiness and satisfaction of life
Timepoint
48 hours before and after the exercise intervention
Method of measurement
Oxford Happiness Questionnaire - Short Form
3
Description
Body composition (body mass index, fat percentage and hip circumference)
Timepoint
48 hours before and after the exercise intervention
Method of measurement
Measure height and weight, subcutaneous fat and hip circumference with scales, tape measure and caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: The experimental group starts the aquaticexercise training program for 6 weeks under the supervision of the researcher (in the Kosar pool in Rasht). The aquatic exercise program is done three times a week for 50 minutes. At the end of the sixth week, the final evaluation is performed and the participants complete the Womak questionnaire again and their weight, height, fat percentage and thigh circumference are measured again.
Category
Rehabilitation
2
Description
Control group: At the beginning and end of the study, they complete the Womak questionnaire and their weight, height, fat percentage and thigh circumference are measured again.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Zibaknar Sports Club
Full name of responsible person
Jamshid Ansari
Street address
Rasht - Zibaknar - Seyed Al-Shohada Street
City
Rasht
Province
Guilan
Postal code
4419865615
Phone
+98 13 3375 2906
Email
solomonansari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Seidavi
Street address
Islamic Azad University of Rasht Branch, Lakan Blv
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13 3375 2906
Email
solomonansari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soleyman Ansari Kolachahi
Position
Non faculty doctor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
second floor, Adibsaber Apartment, next to Esparo restaurant, Prof. Samei Blv.
City
Rasht
Province
Guilan
Postal code
4193193933
Phone
+98 13 3375 2906
Email
solomonansari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soleyman Ansari Kolachahi
Position
Non faculty specialist
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
second floor, Adibsaber Apartment, next to Esparo restaurant, Prof. Samei Blv
City
Rasht
Province
Guilan
Postal code
4193193933
Phone
+98 13 3375 2906
Email
solomonansari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soleyman Ansari Kolachahi
Position
Non faculty specialist
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
2nd floor, Adibsaber Apartment,next to Esparo restauant, Prof. Samei Blv.
City
Rasht
Province
Guilan
Postal code
4193193933
Phone
+98 13 3375 2906
Email
solomonansari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Raw and processed data
When the data will become available and for how long
Start of access period from 1401
To whom data/document is available
Academic researchers, research colleagues and participants
Under which criteria data/document could be used
Use research results and data in future meta-analysis research
From where data/document is obtainable
Corresponding Author
What processes are involved for a request to access data/document