The effect and follow up of neuromuscular exercise in water on strength, co-contraction, quality of life, proprioception and balance of the knee in women with grade 2&3 knee OA
The current research aims to investigate the effect of 8 weeks of neuromuscular exercise in water and its follow up on strength, co-contraction, knee joint proprioception and balance in women with knee osteoarthritis with severity 2 and 3.
Design
Clinical trial with two experimental groups, non-randomized, on 24 patients with knee arthritis.
Settings and conduct
Testing of examinees will be done at the laboratory of the Faculty of Physical Education; presentation of the training protocol will be done in the swimming pool of the Faculty of Physical Education of Bahonar University of Kerman for 8 weeks.
Participants/Inclusion and exclusion criteria
Entry: age 50-65, ability to perform daily activities, absence of inflammatory, nervous, mental illness, having grade two and three knee arthritis
Failure to enter: not meeting the requirements of the health questionnaire, use of sedative and painkillers, presence of abnormality
Intervention groups
We will examine a type of neuromuscular exercises designed in water on women with knee arthritis in two severity groups of two and three knee arthritis, and we will also measure the effect of these exercises on the complications caused by arthritis.
Main outcome variables
Reducing the complications of knee arthritis; Increase the quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231015059728N1
Registration date:2023-11-07, 1402/08/16
Registration timing:registered_while_recruiting
Last update:2023-11-07, 1402/08/16
Update count:0
Registration date
2023-11-07, 1402/08/16
Registrant information
Name
Sahar Khajeh
Name of organization / entity
Shahid bahonar kerman
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 8316
Email address
khaje.sahar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2023-11-16, 1402/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect and follow up of neuromuscular exercise in water on strength, co-contraction, quality of life, proprioception and balance of the knee in women with grade 2&3 knee OA
Public title
The effect and follow up of neuromuscular exercise in water on complications of knee OA
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender and being in the age range of 50 to 65
Ability to walk and perform daily activities without using an assistive device
People with second- and third-degree knee arthritis
Absence of inflammatory disease
Not having a mental or nervous illness
Exclusion criteria:
Having a history of sensorimotor disorders or severe vision problems
Existence of pathological symptoms, history of fracture, surgery and joint disease in the lower limb and knee joint replacement
Not having the requirements of the general health questionnaire and fitness for physical activity
Use of relaxing and pain-relieving medication 48 hours before the test
The presence of any visible abnormalities in the lower limbs
Inability to perform tests or training programs
Participation in regular training programs outside of research
Age
From 50 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Bahonar University of Kerman
Street address
shafa street
City
kerman
Province
Kerman
Postal code
7618759632
Approval date
2023-05-05, 1402/02/15
Ethics committee reference number
IR.UK.REC.1402.002
Health conditions studied
1
Description of health condition studied
Knee arthritis
ICD-10 code
M17.1
ICD-10 code description
Unilateral primary osteoarthritis of knee
Primary outcomes
1
Description
Knee Arthritis
Timepoint
At the beginning of the study (before the start of the intervention) and 59 days after the start of aquatic exercises
Method of measurement
General health questionnaire and KOOS
2
Description
Strength
Timepoint
At the beginning of the study (before the start of the intervention) and 59 days after the start of aquatic exercises
Method of measurement
Electromyography device, surface electrode
3
Description
Co-contraction
Timepoint
At the beginning of the study (before the start of the intervention) and 89"59 days after the start of aquatic exercises
Method of measurement
Electromyography device, surface electrode
4
Description
Quality of life
Timepoint
At the beginning of the study (before the start of the intervention) and 59 days after the start of aquatic exercises
Method of measurement
SF36
5
Description
Proprioception
Timepoint
At the beginning of the study (before the start of the intervention) and 59 days after the start of aquatic exercises
Method of measurement
Autocad software, green skin markers, digital camera for measuring posture.
6
Description
Balance
Timepoint
At the beginning of the study (before the start of the intervention) and 59 days after the start of aquatic exercises
Method of measurement
Biodex
Secondary outcomes
1
Description
Plantar pressure
Timepoint
At the beginning of the study (before the start of the intervention) and 59 days after the start of aquatic exercises
Method of measurement
Plantar pressure measuring device
Intervention groups
1
Description
Intervention group: Women with knee arthritis with severity of 2, 8 weeks of muscle nerve training will be given in the water, muscle nerve training is a type of training that is done in all planes of motion, in all directions, and includes all agility, strength, flexibility, balance and functional training. Sessions A training will be given three days a week for two months and a duration of one hour.
Category
Rehabilitation
2
Description
Intervention group: Women with knee arthritis with severity of 3, 8 weeks of muscle nerve training will be given in the water, muscle nerve training is a type of training that is done in all planes of motion, in all directions, and includes all agility, strength, flexibility, balance and functional training. Sessions A training will be given three days a week for two months and a duration of one hour.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Physical Education
Full name of responsible person
Sahar Khajeh
Street address
Faculty of Physical Education, after the railway bridge, Islamic Republic Blvd.
City
Kerman
Province
Kerman
Postal code
7616913439
Phone
+98 34 3325 7141
Email
khaje.sahar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Dr. Alireza Saeedi
Street address
Pajohesh square, Shahid Bahonar University of Kerman, Faculty of Physical Education
City
KERMAN
Province
Kerman
Postal code
7616913439
Phone
+98 34 3132 3186
Email
khaje.sahar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faculty of Physical Education and Sahar Khajeh
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
Shahid Bahonar University of Kerman
Full name of responsible person
Sahar Khajeh
Position
Tuition
Latest degree
Master
Other areas of specialty/work
sport injury
Street address
Faculty of Physical Education, Shahid Bahonar University of Kerman, Pajohesh Square
City
Kerman
Province
Kerman
Postal code
76116913439
Phone
+98 34 3132 3186
Email
khaje.sahar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Sahar Khajeh
Position
Tuition
Latest degree
Master
Other areas of specialty/work
sport injury
Street address
Faculty of Physical Education, Shahid Bahonar University of Kerman, Pajohesh Square
City
Kerman
Province
Kerman
Postal code
7616913439
Phone
+98 34 3132 3186
Email
khaje.sahar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Sahar Khajeh
Position
Tuition
Latest degree
Master
Other areas of specialty/work
sport injury
Street address
Faculty of Physical Education, Shahid Bahonar University of Kerman, Pajohesh Square
City
Kerman
Province
Kerman
Postal code
7616913439
Phone
+98 34 3132 3186
Email
khaje.sahar@yahoo.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only a part of the data, such as the information related to the main outcome or the like, can be shared.
When the data will become available and for how long
"Starting the access period 6 months after printing the results".
To whom data/document is available
It will be available to everyone
Under which criteria data/document could be used
It can be used to improve scientific documentation.
From where data/document is obtainable
sahar khajeh
What processes are involved for a request to access data/document