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Trial registered on ANZCTR


Registration number
ACTRN12618001434280
Ethics application status
Approved
Date submitted
8/08/2018
Date registered
27/08/2018
Date last updated
27/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of home exercise program with group education among adults with knee osteoarthritis.
Scientific title
Effectiveness of well-structured home exercise program with additional group education in improving pain, disability and functional mobility among adults with knee osteoarthritis.
Secondary ID [1] 295749 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 309146 0
Condition category
Condition code
Musculoskeletal 308032 308032 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 308219 308219 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the experimental group (n=15) received well-structured home exercise program (HEP), additional group education and usual physiotherapy treatment once a week for continuous 8 weeks.
A booklet of the home exercise program with additional group education was given to the participants in the experimental group as a guideline and daily checklist for self-management. This booklet is designed specifically for this study and the contents of the HEP was adopted from several previous studies. The booklet consists of stretching and strengthening exercises such as lower limb stretching, straight leg raise, static quadriceps, mini squat, sit to stand and knee extension exercises (Bruce-Brand et al. 2012). Each of the exercises consists of explanation (description of the proper position, equipment, purpose, progression) and illustration. Each of these exercises was conducted for at least 3 times per day and at least 4 days a week (Chen & Onishi 2012). There was no specific guideline in term of exercises' intensity for the HEP. Participants performed the exercises based on the HEP booklet as advised; 3 times a day and at least 4 days a week, and the intensity is decided by the participants themselves. In addition, every two-week phone call was received by the participants as a follow up for the progression of home exercise program (Thomas et al. 2002).

References for the HEP booklet:
1. Bruce-Brand, R. A., Walls, R. J., Ong, J. C., Emerson, B. S., O’Byrne, J. M. & Moyna, N. M. 2012. Effects of home-based resistance training and neuromuscular electrical stimulation in knee osteoarthritis: a randomized controlled trial. BMC Musculoskeletal Disorders 13(1): 1
2. Chen, H. & Onishi, K. 2012. Effect of home exercise program performance in patients with osteoarthritis of the knee or the spine on the visual analogue scale after discharge from physical therapy. International Journal of Rehabilitation Research 35(3): 275-277.
3. Thomas, K., Muir, K., Doherty, M., Jones, A., O'Reilly, S. & Bassey, E. 2002. Home-based exercise programme for knee pain and knee osteoarthritis: randomised controlled trial. BMJ 325(7367): 752.


Usual physiotherapy care (individually-tailored exercise) comprised of electro modalities for pain management, range of motion exercise, stretching, strengthening, balance exercise, functional exercises such as sit to stand and stairs climbing. There were no specific guidelines used for usual physiotherapy treatment.

Attendance checklist was taken to monitor participants’ adherence in this study. Knee Injury and Osteoarthritis Outcome Score (KOOS), Time Up & Go (TUG) and Visual Analog Scale (VAS) were measured at baseline and 8th week of study. Measurement of outcomes was carried out by an independent assessor at week 0 and week 8 of intervention with the use of standardized tools.
Intervention code [1] 312081 0
Rehabilitation
Comparator / control treatment
Participants in the control group received only usual physiotherapy treatment (individually-tailored exercise) once a week for continuous 8 weeks. Each usual physiotherapy care comprised of electro modalities for pain management, range of motion exercise, stretching, strengthening, balance exercise, functional exercises such as sit to stand and stairs climbing. There were no specific guidelines used for the exercise programme in the control group. Attendance checklist was taken to monitor participants’ adherence in this study. Knee Injury and Osteoarthritis Outcome Score (KOOS), Time Up & Go (TUG) and Visual Analog Scale (VAS) were measured at baseline and 8th week of study. Measurement of outcomes was carried out by an independent assessor at week 0 and week 8 of intervention with the use of standardized tools.
Control group
Active

Outcomes
Primary outcome [1] 307047 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)

-This instrument used to evaluate the participants view regarding their knee and associated problem as well as the consequences of short-term and long-term knee injury and osteoarthritis.
Timepoint [1] 307047 0
Measurement of the outcome was carried out by an independent assessor at week 0 (pre-intervention) and week 8 (post-intervention) with the use of standardized tools.
Secondary outcome [1] 350484 0
Time Up & Go (TUG)

-Time Up and Go was used as an outcome measure to evaluate functional status of the participants.
Timepoint [1] 350484 0
Measurement of the outcome was carried out by an independent assessor at week 0 (pre-intervention) and week 8 (post-intervention) with the use of standardized tools.
Secondary outcome [2] 350485 0
Visual Analog Scale (VAS)

-Visual analogue scale (VAS) has been widely used for pain assessment.
Timepoint [2] 350485 0
Measurement of the outcome was carried out by an independent assessor at week 0 (pre-intervention) and week 8 (post-intervention) with the use of standardized tools.

Eligibility
Key inclusion criteria
-Adults with knee OA that seeking treatment as an outpatient at the physiotherapy department at Hospital Canselor Tuanku Muhriz (HCTM) .
-Adults aged above 50 years old who had knee pain scored at >30 mm on a 100 mm VAS and able to walk for at least 3m.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-The exclusion criteria were having inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and systemic lupus erythematosus,
-Admitted past 3 months due to cardiovascular disease.
-Had participated in any structured exercise program presently.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data was analyzed using Statistic Product for Statistical Solutions (SPSS) version 22.0 (SPSS Inc. Chicago, USA). Repeated measure ANOVA was used to analyze the effects of time, group and time group interaction. Significant level was set at p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/03/2017
Date of last participant enrolment
Anticipated
Actual
3/04/2017
Date of last data collection
Anticipated
Actual
16/06/2017
Sample size
Target
33
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 20739 0
Malaysia
State/province [1] 20739 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 300340 0
University
Name [1] 300340 0
Universiti Kebangsaan Malaysia
Country [1] 300340 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia
Address
Universiti Kebangsaan Malaysia, Jalan Raja Muda Aziz, 50300 Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 299810 0
None
Name [1] 299810 0
Address [1] 299810 0
Country [1] 299810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301152 0
Secretariat for Research and Ethics of Universiti Kebangsaan Malaysia.
Ethics committee address [1] 301152 0
SEKRETARIAT PENYELIDIKAN PERUBATAN & INOVASI Pusat Perubatan Universiti Kebangsaan Malaysia, Tingkat 15, Bangunan Praklinikal, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur.
Ethics committee country [1] 301152 0
Malaysia
Date submitted for ethics approval [1] 301152 0
04/11/2016
Approval date [1] 301152 0
17/01/2017
Ethics approval number [1] 301152 0
UKM PPI/111/8/JEP-2017-021

Summary
Brief summary
Objective: To examine the effectiveness of a well-structured home exercise program (HEP) with additional group education among adults with knee osteoarthritis (OA). Methods: This clinical trial involved 30 adults with knee OA in both experimental (n=15) and control (n=15) groups with a mean age (SD) of 65.27(6.86) and 65.60(8.70) years respectively. The experimental group received usual physiotherapy treatment with a well-structured HEP and additional group education, while the control group only received usual physiotherapy treatment. Both groups performed the intervention once a week for a continuous 8 weeks. Knee Injury and Osteoarthritis Outcome Score (KOOS), Time Up & Go (TUG) and Visual Analog Scale (VAS) were measured pre-post intervention by an independent assessor with the use of standardized tools. Results: Repeated measure ANOVA showed a significant main effect of time in all outcome measures which indicated that following 8 weeks of intervention, both groups showed reduction in pain, disability and improvement in functional mobility. However, experimental (VAS 45%, TUG 17%, KOOS 36%) demonstrated a greater percentage of improvements in all outcomes compared with control group (VAS 5%, TUG -2%, KOOS 3%). A significant interaction effect in all outcome measures also found which concluded that there are differences in term of effectiveness between the two intervention in experimental and control group over time. Conclusion: Combination of physiotherapy treatment with well-structured HEP and group education is effective in improving functional mobility, reduction of pain and disability among adults with knee OA.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2952 2952 0 0
/AnzctrAttachments/375743-Ethical Approval Letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 86030 0
A/Prof Devinder Kaur Ajit Singh
Address 86030 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur, Malaysia.
Country 86030 0
Malaysia
Phone 86030 0
+60392897676
Fax 86030 0
+60326989506
Email 86030 0
[email protected]
Contact person for public queries
Name 86031 0
A/Prof Devinder Kaur Ajit Singh
Address 86031 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur, Malaysia.
Country 86031 0
Malaysia
Phone 86031 0
+60392897676
Fax 86031 0
+60326989506
Email 86031 0
[email protected]
Contact person for scientific queries
Name 86032 0
A/Prof Devinder Kaur Ajit Singh
Address 86032 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur, Malaysia.
Country 86032 0
Malaysia
Phone 86032 0
+60392897676
Fax 86032 0
+60326989506
Email 86032 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of Self-management Program as Adjunctive to Usual Rehabilitation Exercise on Pain and Functional Outcomes in Knee Osteoarthritis: A Randomized Controlled Trial.2023https://dx.doi.org/10.34172/jrhs.2023.104
N.B. These documents automatically identified may not have been verified by the study sponsor.