Effectiveness of a combined exercise and physiotherapy intervention in improving functional activity of patients with knee osteoarthritis in Muslim prayer movements
| ISRCTN | ISRCTN17933625 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17933625 |
| Secondary identifying numbers | no E.5.a/176/KEPK-UMM/IX/2019 |
- Submission date
- 21/04/2021
- Registration date
- 23/04/2021
- Last edited
- 04/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Developing effective interventions for relieving pain and improving physical function of the knee in Muslim prayer movements is a critical concern in meeting their religious commitments and improving their general quality of life (QoL). However, the effects of exercise intervention duration on the functional activity of knee osteoarthritis (OA) patients in performing daily life activities, particularly Muslim praying movements, are not yet clear. Hence, an investigation was performed into the effectiveness of combined exercise and physiotherapy intervention for 6 or 12 weeks on the functional activity of individuals with knee osteoarthritis.
Who can participate?
Participate were age 50 years old and above, and both male and female participants with knee osteoarthritis were recruited.
What does the study involve?
The recruited participants were randomly divided into three groups. Group I and Group II) received combined exercise therapy intervention consisting of muscle strengthening, stationary cycling and walking exercise, and physiotherapy modalities. The combined intervention was performed for 3 sessions a week, with a duration of 60 minutes per session. Group I received intervention for 12 weeks, while Group II received intervention for just 6 weeks. Group III, as the control group, received no exercise intervention at all but performed physiotherapy modalities for 6 weeks at a rate of 3 sessions a week. During the study period, the participants’ medications were standardized and remained unchanged. The study was divided into 3 stages, namely baseline, 1st follow-up and 2nd follow-up. At baseline, all of the participants were assessed by six-minute walking tests (6MWT) and chair stand tests (CST), and were asked to report their pain intensity (VAS scale), QoL (SF-36 questionnaire), and perceived health and physical function (WOMAC questionnaire).
What are the possible benefits and risks of participating?
The possible benefit of the implementation of the training activities described in the present study were improving knee function and reducing the pain intensity of individuals with knee OA when performing daily life activities, including Muslim praying movements, and there were no side effect of the intervention given.
Where is the study run from?
The physiotherapy department University of Muhammadiyah Malang (Indonesia)
When is the study starting and how long is it expected to run for?
September 2019 to February 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Rakhmad Rosadi (rakhmad21@gmail.com)
Contact information
Public
Perum tunjung sekar damai blok J6
Malang
65142
Indonesia
 ORCID ID |
0000-0002-8412-7441 |
|---|---|
| Phone | +62 85132478801 |
| rahkmad@umm.ac.id |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | ISRCTN17933625_PIS.pdf |
| Scientific title | The effect of strengthening, isometric and isotonic exercise for knee osteoarthritis patients in Malang - Indonesia |
| Study objectives | Patients who receive a longer period of training exercise intervention (12 weeks) will exhibit better knee function, lower pain intensity and a higher QoL than those who do not |
| Ethics approval(s) | Approved 05/09/2019, Health Research Ethics University of Muhammadiyah Malang (Jl. Bendungan Sutami No.188, Sumbersari, Kec. Lowokwaru, Kota Malang, Jawa Timur 65145, Indonesia; +628125243720; patma@umm.ac.id), ref: E.5.a/176/KEPK-UMM/IX/2019 |
| Health condition(s) or problem(s) studied | Knee osteoarthritis |
| Intervention | The participants in Group I and Group II performed combined strengthening and stationary cycling intervention, walking and physiotherapy for a total of 36 sessions (12 weeks, 3 times a week) and 18 sessions (6 weeks, 3 times a week), respectively. The participants in Group III underwent physiotherapy modalities for 18 sessions (6 weeks, 3 times a week). All of the sessions were supervised by an experienced physiotherapist. Missed sessions were compensated during the subsequent weeks such that each participant completed the full complement of sessions for their assigned group. Randomization was by sealed envelope. |
| Intervention type | Behavioural |
| Primary outcome measure | Functional activity measured by WOMAC at baseline, 1st follow up (6 weeks) and 2nd follow up (12 weeks) |
| Secondary outcome measures | 1. Pain measured using the visual analogue score (VAS) at baseline, 1st follow up (6 weeks) and 2nd follow up (12 weeks). 2. Walking ability measured by 6 minutes walking test at baseline, 1st follow up (6 weeks) and 2nd follow up (12 weeks). 3. Functional fitness measured by chair stand test at baseline, 1st follow up (6 weeks) and 2nd follow up (12 weeks). 4. Quality of life measured by questionnaire SF-36 at baseline, 1st follow up (6 weeks) and 2nd follow up (12 weeks). |
| Overall study start date | 05/09/2019 |
| Completion date | 15/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 45 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Clinically diagnosed with knee OA by physician 2. Treated by physiotherapist during previous 4 weeks 3. Grade 1 or higher in the Kellgren and Lawrence radiographic classification 4. Minimum age 50 years old 5. Pain level on Visual Analog Scale (VAS) greater than 4 6. Willingness to commit to a 12-week study period |
| Key exclusion criteria | 1. Scheduled for joint surgery 2. Having knee injection within previous 2 months 16 3. Minimally assisted during walking 4. Diagnosed with fibromyalgia 5. Unstable heart condition 6. Physical activity more than twice a week (with a total duration of 60 minutes per week) 17 7. Unable to pedal a stationary bicycle |
| Date of first enrolment | 06/09/2019 |
| Date of final enrolment | 15/12/2019 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
l. Bandung No.1
Penanggungan
Kec. Klojen
Kota Malang
Jawa Timur
Malang
65113
Indonesia
Sponsor information
University/education
Jl. Bandung No.1
Penanggungan
Kec. Klojen
Kota Malang
Jawa Timur
Malang
65113
Indonesia
| Phone | +62 341 551253 |
|---|---|
| fisioterapi@umm.ac.id | |
| Website | https://www.umm.ac.id/ |
"ROR" |
https://ror.org/01j1wt659 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/05/2021 | No | Yes |
Additional files
- ISRCTN17933625_PIS.pdf
- uploaded 04/05/2021
Editorial Notes
04/05/2021: The participant information sheet was uploaded as an additional file.
22/04/2021: Trial's existence confirmed by Health Research Ethics University of Muhammadiyah Malang
