UMIN-CTR Clinical Trial

Basic information
Public title	Impact of home exercise program on self-efficacy and quality of life among primary knee osteoarthritis patients: a randomized controlled clinical study.
Acronym	Impact of home exercise program on self-efficacy and quality of life among primary knee osteoarthritis patients: a randomized controlled clinical study.
Scientific Title	Impact of home exercise program on self-efficacy and quality of life among primary knee osteoarthritis patients: a randomized controlled clinical study.
Scientific Title:Acronym	Impact of home exercise program on self-efficacy and quality of life among primary knee osteoarthritis patients: a randomized controlled clinical study.
Region	Africa

Condition
Condition	Impact of home exercise program on self-efficacy and quality of life among primary knee osteoarthritis patients: a randomized controlled clinical study.
Classification by specialty	Medicine in general Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to investigate the effect of 24 weeks home exercise program on pain severity, Self-Efficacy and quality of life scores in primary knee osteoarthritis patients and to determine adherence to exercises
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Exercise self-efficacy scale Visual analogue scale Quality of life measurement after 6 months
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Medicine Maneuver
Interventions/Control_1	Patients randomized to the intervention exercise group were subjected to one-hour educational session on the importance of home exercises , the participants were taught the exercises and conducted in front of the physiatrist to address any questions. They were given printout of illustrated booklet and videos in Arabic for exercise prescription and received a monthly phone call for motivation and to support exercises compliance. This was supported by an individual session, which took place after 3 months. During this session, the physiatrist received the exercise log to asses compliance over the previous period and focused on the beneficial role of exercise therapy and encouraging patient to continue home exercises .plus medical treatment and lifestyle recommendations.
Interventions/Control_2	medical treatment and lifestyle recommendations
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	patients who met the American College of Rheumatology clinical and radiological criteria for primary knee osteoarthritis were recruited.
Key exclusion criteria	Participants with history of knee trauma, surgery, inflammatory knee pain or history intra-articular injections within the last three months and other medical disease that may affect their ability to perform exercise were excluded.
Target sample size	348

Research contact person
Name of lead principal investigator	1st name Rabab Middle name S Last name Zaghlo
Organization	Zagazig university
Division name	faculty of medicine
Zip code	44519.
Address	Egypt
TEL	00966532342014
Email	rababzaghlol@yahoo.com

Public contact
Name of contact person	1st name rabab Middle name S Last name zaghlol
Organization	Zagazig university
Division name	faculty of medicine
Zip code	44519
Address	Egypt
TEL	00966532342014
Homepage URL
Email	rababzaghlol@yahoo.com

Sponsor
Institute	Faculty of medicine, Zagazig unversity, Egypt
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Zagazig university, faculty of medicine
Address	Egypt
Tel	0552307830
Email	info_medicine@zu.edu.eg

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	457
Results	At six months follow up, significant improvements were found in the exercise group in all the measured parameters compared to baseline assessment and to the control group .
Results date posted	2021 Year 01 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events	non
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 01 Day
Date of IRB	2018 Year 07 Month 10 Day
Anticipated trial start date	2018 Year 07 Month 23 Day
Last follow-up date	2020 Year 07 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 25 Day
Last modified on	2021 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049223