The aim of this study is to determine the effect of eight weeks of selected exercises at home on women with knee osteoarthritis.
Design
Single-blind randomized clinical trial with control group (n=34).
Settings and conduct
The present quasi-experimental study is performed in the rehabilitation laboratory of Arak University. The experimental group perform home-based exercise for 8 weeks, 3 sessions per week.
Knee Injury and Osteoarthritis Outcome Score
Western Ontario and McMaster Universities Arthritis Index
Static and dynamic balance, quality of life, fear of falling, physical and cognitive self-efficacy measure with 4 stage static balance test, timed up and go test, OPQOL-35, FES-I questionnaire, SSEA and MMSE quesionnaire respectively. Data analyzer and evaluators do not know how to allocate and group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Confirmation of orthopedic specialist that she has osteoarthritis, age 45 to 60 years, knee pain for at least three months, being at the functional level II and III
Exclusion criteria: History of knee surgery, Body mass index more than 30, Any illness that can affect the research variables.
Intervention groups
Intervention group: Participants in the intervention group perform selected exercises for eight weeks, three sessions per week. Control group: The control group will have the usual routine of their lives.
Main outcome variables
Range of motion of joint
Q angle
Pain
Quality of life
Performance
Balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200204046368N8
Registration date:2021-11-18, 1400/08/27
Registration timing:registered_while_recruiting
Last update:2021-11-18, 1400/08/27
Update count:0
Registration date
2021-11-18, 1400/08/27
Registrant information
Name
Zahra Raeisi
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3492
Email address
z_raisi13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-18, 1400/08/27
Expected recruitment end date
2021-11-24, 1400/09/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of a home-based exercise intervention on women with knee osteoarthritis
Public title
The home-based exercise intervention and women with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of orthopedic specialist that she has osteoarthritis
Age 45 to 60 years
Knee pain for at least three months
Being at the functional level II and III
Exclusion criteria:
History of knee surgery
Body mass index more than 30
Any illness that can affect the research variables
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is parallel. The randomization unit is individual.
The Rand List software is used to randomly assign subjects to study groups. At , the number of subjects and groups is given to the software.
Then, with this software, each subject is assigned a code. A group is then randomly assigned to each code by the software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not be aware of the groups classification. The information of the groups will be provided to the data analyzer in the form of numbers 1, 2, 3 and for each participant with a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2021-10-25, 1400/08/03
Ethics committee reference number
IR.ARAKMU.REC.1400.185
Health conditions studied
1
Description of health condition studied
osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain
Timepoint
Before and after of intervention
Method of measurement
Visual analogue scale
2
Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
Knee Injury and Osteoarthritis Outcome Score (KOOS)
3
Description
Knee range of motion
Timepoint
Before and after intervention
Method of measurement
Goniometer
Secondary outcomes
1
Description
Q angle
Timepoint
Before and after intervention
Method of measurement
Goniometer
2
Description
Range of motion of hip joint
Timepoint
Before and after intervention
Method of measurement
Goniometer
3
Description
Static balance
Timepoint
Before and after intervention
Method of measurement
Single leg stance
4
Description
Dynamic balance
Timepoint
Before and after intervention
Method of measurement
Time up and go test
5
Description
Performance
Timepoint
Before and after intervention
Method of measurement
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Intervention groups
1
Description
Intervention group: The intervention group performs selected home-based exercises for 8 weeks, 3 sessions per week. Subjects are monitored by researchers every week. They write down their activity level in a notebook.Exercise booklet including complete guide and video including explanations and how to perform the exercises correctly will be provided to the participants.
Category
Rehabilitation
2
Description
Control group: The control group performs their normal activities for 8 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak university
Full name of responsible person
Zahra Raeisi
Street address
Shariati street
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3277 4031
Email
Z_raisi13@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university
Full name of responsible person
Alireza Fazlali
Street address
Shariati street
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 2000
Email
d-research@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Basij Square, Arak University
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.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