The Effects of Water Exercise Training on Motor Symptoms and Mechanical Pains of Postmenopausal Women with Osteoarthritis
Design
This is a randomized, double-blind, parallel-controlled trial.
Settings and conduct
Patients in the intervention group will receive 12 sessions of light exercise in the shallow water of the pool for 12 sessions each week, while the control group will not take any action. The intervention is in the pool of Tabriz University of Medical Sciences. The researcher and the person analyzing the data are blind during the study and the patients will be randomly divided into two groups using SPSS software.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
Minimum age 45 years
Osteoarthritis
Menopause
Exclusion criteria include:
Nervous pains
Lumbar disc disease
Lower extremity defect
Intervention groups
Patients in the intervention group will do light water exercises three times a week for 12 sessions. The control group will receive no intervention.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N11
Registration date:2019-10-02, 1398/07/10
Registration timing:prospective
Last update:2019-10-02, 1398/07/10
Update count:0
Registration date
2019-10-02, 1398/07/10
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-07, 1398/07/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Water Exercise Training on Motor Symptoms and Mechanical Pains of Postmenopausal Women with Osteoarthritis
Patients will be divided into control and intervention groups using SPSS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher and the data analyzer are unaware of the type of intervention and the type of intervention received for each group and are blind during the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.TBZMED.REC.1397.1059
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
M79.6
ICD-10 code description
Pain in limb, hand, foot, fingers and toes
Primary outcomes
1
Description
Pain
Timepoint
Monthly and from the beginning of the intervention to three months after the end of the intervention
Method of measurement
Visual Analogue Scale
2
Description
Severity of osteoarthritis
Timepoint
Monthly and from the beginning of the intervention to three months after the end of the intervention
Method of measurement
Osteoarthritis severity questionnaire (KOSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will enter the intervention group after random assignment. They will have three sessions of light exercise each week and eventually 12 sessions of light exercise in the pool. This is how they will perform simple stretching movements including slow and medium speed walks inside the pool.
Category
Rehabilitation
2
Description
Control group: No action will be taken for this group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Abbasali Dorosti
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 41 3335 5921
Email
Dorostia44@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Abbasali Dorosti
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
dorostia44@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abbasali Dorosti
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Dorostia44@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available