UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043117 |
|---|---|
| Receipt number | R000049223 |
| Scientific Title | Impact of home exercise program on self-efficacy and quality of life among primary knee osteoarthritis patients: a randomized controlled clinical study. |
| Date of disclosure of the study information | 2021/01/25 |
| Last modified on | 2021/01/25 02:52:17 |
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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
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
rababzaghlol@yahoo.com
Sponsor or person
Institute
Faculty of medicine, Zagazig unversity, Egypt
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049223
