Knee OsteoarthritisNCT06268925
The Feasibility And Efficacy Of A Telerehabilitation Program For People With Knee Osteoarthiritis In Sri Lanka
A study testing Exercises in people with Knee Osteoarthritis, run by University of Peradeniya at 1 site in Sri Lanka.
Trial summary
it will be 8 week zoom program of exercises for knee osteo arthritis. participant will be selected according to elegibilty criteria. pre and post measurements will be obtained. then feasibility and efficacy will be assesed. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSri Lanka
- Study dates
- 22 Feb 2024to 3 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet National Institute for Health and Care Excellence clinical criteria for OA
- Age ≥45 years.
- Activity-related knee joint pain.
- Morning knee stiffness ≤ 30 min.
- Report history of knee pain ≥ 3mths.
- Report knee pain on most days of the past month.
Show all 9Show fewer
- Report an average pain score of at least 4 on an 11-point numeric rating scale during walking over the previous week.
- Report difficulty walking and climbing stairs.
- Have access to a device with internet connection: if they can use without assistance if possible
Who cannot join
- On waiting list for/planning knee/hip surgery in next 12 months.
- Previous arthroplasty on affected knee.
- Recent knee surgery (past 6 months).
- Consulting/ed physiotherapy or doing strengthening exercise for knee (past 6 months).
- Self-reported inflammatory arthritis (eg rheumatoid arthritis).
- Any neurological condition affecting lower limbs; and/or any unstable/uncontrolled cardiovascular condition.
- Clearance to participate from a general practitioner will be required for anyone who reported a fall (past 12 months) or is house-bound due to immobility
Trial locations and contacts
1 site in 1 country.
About this study
it will be 8 week zoom program of exercises for knee osteo arthritis. participant will be selected according to elegibilty criteria. pre and post measurements will be obtained. then feasibility and efficacy will be assesed.
Read the detailed description
This research is to check the feasibility and efficacy of a telerehabilitation program for people with knee osteoarthritis in Sri Lanka. 14 people with knee OA will be recruited according to the inclusion and exclusion criteria. Study group will be selected with advertisement on facebook.
People who are interested will be included. Exercise booklet and instruction materials will be given to patients and initial measurement of Pain using VAS scale, 30 CST (30 second chair stand test)- Lower extremity muscle strength and dynamic balance, WOMAC (Western Ontario and McMaster Universities Arthritis Index)- pain, stiffness and physical activity will be obtained. Study group will go for 8 weeks of zoom program of exercises. Classes will be taken by the physiotherapist 3 days per week with standardized program called PEAK.knee log book will be maintained by therapist. Post 8 week same measurements on baseline will be reassessed and additional to that, Feasibility and acceptability for tele rehabilitation and Patient adherence and Safety will be assessed with attrition rate, satisfaction rate , participation to the program and measuring adverse effect respectively. Statistical Package for Social Science (SPSS) version for Windows will be used for data analysis. Pair t test will be used to compare the baseline and post 8 week results.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercises
- Keywords
- Telerehabilitation, Feasibility, Efficacy, Sri Lanka
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
number of exercises will be guided to do through zoom
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | single arm group exercises will be given to the patients Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of telerehabilitation program
measured by attrition rate which is the measure of screened individual who are eligible but refused to participate and proportion of screened individuals who enrolled in to the study
Measured: post 8 weeks of exercise program
Feasibility and acceptability
asking patients "how satisfied they are about tele rehabilitation program" respectively at 8 weeks post.
Measured: post 8 week
Secondary outcomes (3)
lower extremity muscle strength and dynamic balance
30 second chair stand test
Measured: pre and post 8 week of exercise program
pain,
assessed by Visual Analogue Scale containing 0 to 10 scale
Measured: Pre and post 8 weeks of exercise program
pain stiffness and physical activity
WOMAC scale (Western Ontario and McMaster Universities Arthritis Index)
Measured: pre and post 8 week of exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start22 Feb 2024 (estimated)
- Primary completion22 Apr 2024 (estimated)
- Study completion3 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 14 people with knee osteoarthritis will be recruited and conducted group classes through zoom
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Peradeniya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.S.F.Sarjana, University of Peradeniya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268925
- Sponsor's protocol ID
- UAHS
- Status last verified
- Feb 2024
- First submitted
- 2 Dec 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility And Efficacy Of A Telerehabilitation Program For People With Knee Osteoarthiritis In Sri Lanka
- ClinicalTrials.gov ID
- NCT06268925
- Acronym / sponsor ID
- UAHS
- Conditions
- Knee Osteoarthritis
- Keywords
- Telerehabilitation, Feasibility, Efficacy, Sri Lanka
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of PeradeniyaUniversity, hospital or other
- Study start
- 22 Feb 2024 (estimated)
- Primary completion
- 22 Apr 2024 (estimated)
- Study completion
- 3 May 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
it will be 8 week zoom program of exercises for knee osteo arthritis. participant will be selected according to elegibilty criteria. pre and post measurements will be obtained. then feasibility and efficacy will be assesed.
Detailed description
This research is to check the feasibility and efficacy of a telerehabilitation program for people with knee osteoarthritis in Sri Lanka. 14 people with knee OA will be recruited according to the inclusion and exclusion criteria. Study group will be selected with advertisement on facebook.
People who are interested will be included. Exercise booklet and instruction materials will be given to patients and initial measurement of Pain using VAS scale, 30 CST (30 second chair stand test)- Lower extremity muscle strength and dynamic balance, WOMAC (Western Ontario and McMaster Universities Arthritis Index)- pain, stiffness and physical activity will be obtained. Study group will go for 8 weeks of zoom program of exercises. Classes will be taken by the physiotherapist 3 days per week with standardized program called PEAK.knee log book will be maintained by therapist. Post 8 week same measurements on baseline will be reassessed and additional to that, Feasibility and acceptability for tele rehabilitation and Patient adherence and Safety will be assessed with attrition rate, satisfaction rate , participation to the program and measuring adverse effect respectively. Statistical Package for Social Science (SPSS) version for Windows will be used for data analysis. Pair t test will be used to compare the baseline and post 8 week results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 14 people with knee osteoarthritis will be recruited and conducted group classes through zoom
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Exercisessingle arm group exercises will be given to the patients |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meet National Institute for Health and Care Excellence clinical criteria for OA
- Age ≥45 years.
- Activity-related knee joint pain.
- Morning knee stiffness ≤ 30 min.
- Report history of knee pain ≥ 3mths.
Key exclusion criteria (7 listed)
- On waiting list for/planning knee/hip surgery in next 12 months.
- Previous arthroplasty on affected knee.
- Recent knee surgery (past 6 months).
- Consulting/ed physiotherapy or doing strengthening exercise for knee (past 6 months).
- Self-reported inflammatory arthritis (eg rheumatoid arthritis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercisesnumber of exercises will be guided to do through zoom | Other | Study group |
Primary outcome
Efficacy of telerehabilitation program
Time frame: post 8 weeks of exercise program
measured by attrition rate which is the measure of screened individual who are eligible but refused to participate and proportion of screened individuals who enrolled in to the study
Feasibility and acceptability
Time frame: post 8 week
asking patients "how satisfied they are about tele rehabilitation program" respectively at 8 weeks post.
3 secondary outcomes
lower extremity muscle strength and dynamic balance
Time frame: pre and post 8 week of exercise program
pain,
Time frame: Pre and post 8 weeks of exercise program
pain stiffness and physical activity
Time frame: pre and post 8 week of exercise program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Knee Osteoarthritis, run by University of Peradeniya at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of telerehabilitation program (time frame: post 8 weeks of exercise program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.