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The Effect of Home-based Rehabilitation Ttraining on Pain, Performance, General Health and Quality of Life in Patients with Knee Osteoarthritis

Protocol summary

Summary
Objective: The effect of home-based rehabilitation training on pain, performance, general health and quality of life in patients with knee osteoarthritis Methodology: This is an experimental study. Samples of this study were 74 patients who conformed to the inclusion criteria (no history of surgical-related disease, having radiological symptoms of osteoarthritis in knee with a physician's approval, and non-use of an intra-articular injectable drug). They were selected among all patients with knee osteoarthritis referring to the clinic Nos. 2 of Persian Gulf Bushehr from 2017/10/23 to 2018/02/20. They were assigned to two intervention and control groups by randomized blocking method. Research intervention for each intervention group was three 1-hour training sessions that took place individually and face-to-face over the course of 3 consecutive days and follow up was continued for two months after home-based training but it was not given to the educational control group. Pain, performance, general health and quality of life in both groups before and after two months of intervention were measured using a visual analog scale of pain, a questionnaire, a general health questionnaire, and a (SF-12) questionnaire. Data analysis was done by descriptive statistical tests and at a significant level of 95%. Outcome: Rehabilitation training by nurses, as an inexpensive, accessible and effective intervention at home, is expected to be an effective step in reducing pain, improving performance, general health and quality of life in patients with knee osteoarthritis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017100218117N2
Registration date: 2017-11-19, 1396/08/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Zeinab Jokar
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1455 2247
Email address
z.jokar@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Home-based Rehabilitation Ttraining on Pain, Performance, General Health and Quality of Life in Patients with Knee Osteoarthritis
Public title
The Effect of Home-based Rehabilitation on the Treatment of Knee Qsteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: No history of surgical related disease (such as joint replacement, joint repair), having radiological symptoms of osteoarthritis in knee with a physician's approval, non-use of an intra-articular injectable drug, the absence of any mental and psychological illness according to the patient's own statements, and independence in self-care. Exclusion criteria: The first referral of the patient and the lack of diagnosis by the doctor, the lack of regular referral of the patient, the patient's reluctance to continue treatment, and exacerbation of symptoms.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
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 Bushehr University of Medical Sciences
Street address
University of Medical Sciences, Rishehr St,Bushehr, Iran
City
Bushehr
Postal code
7518759577
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
IR.BPUMS.Rec.1396.82

Health conditions studied

1

Description of health condition studied
Osteoarthritis
ICD-10 code
M17
ICD-10 code description
[Gonarthrosis [arthrosis of knee

Primary outcomes

1

Description
pain
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Visual Scale of Pain

2

Description
Performance
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Scale KOOS

3

Description
general health
Timepoint
Before the intervention, two months after the intervention
Method of measurement
General Health Questionnaire

4

Description
Quality of Life
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Quality of Life Questionnaire (SF-36)

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group: Implementation of three 1-hour sessions "Individual training and practice in the following order: The first training session on knee osteoarthritis, the causes of symptoms, symptoms, and a simple language diet for one hour is explained. The second session is about the pharmaceutical diet, proper sitting and lifting, and the patient is asked to practice in the presence of the researcher in order to ensure that it is accurate. The third session is about exercising and Range of Motion (ROM) exercises, and the patient is required to perform exercises in the presence of a researcher in order to ensure that it is accurate. Also, a review of the two sessions is done and the questions are answered to the patient and will be provided to the patients at the end of the session on the educational curriculum related to the training sessions. The patient is then asked to repeat the stretching exercises on a daily basis and how to sit up and get up and keep up-to-date, and complete all the training tips and exercises for two months, and a checklist of hints and exercises that should be done throughout the day. He will be given a mark on them. The checklist is also available to the researcher, and the researcher will contact the patient once a week to ensure that he or she is practicing and observing educational issues".
Category
Rehabilitation

2

Description
"The control group: does not receive rehabilitation training and receive routine therapies."
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic No. 2 of the Persian Gulf Shohada
Full name of responsible person
Zahra Hoseinabadi
Street address
Clinic No. 2 of the Persian Gulf Shohada, Justice Crossroads, Bushehr, Iran.
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Bushehr University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Khamisipour
Street address
University of Medical Sciences, Rishahr St, Bushehr, Iran.
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Bushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Zahra Hosseinabadi
Position
Bachelor
Other areas of specialty/work
Street address
University of Medical Sciences, Rishahr St, Bushehr, Iran.
City
Bushehr
Postal code
Phone
+98 77 3345 0084
Fax
Email
Hosseinabadz374@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Zeinab Jokar
Position
Masters / Coach
Other areas of specialty/work
Street address
University of Medical Sciences, Rishahr St, Bushehr, Iran.
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0084
Fax
Email
Z.Jokar@bpums.ac.ir;Aram.jokar@gmail.com
Web page address
www.bpums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Zeinab Jokar
Position
Masters / Coach
Other areas of specialty/work
Street address
University of Medical Sciences, Rishahr St, Bushehr, Iran.
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0084
Fax
Email
Z.Jokar@bpums.ac.ir; Aram.jokar@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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