Osteoarthritis, KneeNCT05810376
Effects of Digital-based Physical Activity Intervention in Individuals With Knee Osteoarthritis
A study testing Digital-based physical activity intervention and Patient education and exercise in people with Osteoarthritis, Knee, run by Trakya University.
Trial summary
Physical activity is recommended in the guidelines to improve pain and function in the treatment of knee OA, regardless of the severity of the disease, but still, patients rarely do enough physical activity. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Digital-based physical activity intervention and Patient education and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Jun 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 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Knee Osteoarthritis* (ACR criteria)
- 50 years old or over 50 years old
- Pain or discomfort for a total of 28 days or more than 28 days on consecutive or separate days in the past year
- Patients with daily internet access will be included in the study.
Who cannot join
- Patients with a previous diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica, connective tissue diseases, fibromyalgia or gout
- Patients with a history of using antirheumatic drugs or gout medications
- Patients who have had previous knee arthroplasty and are on the waiting list for total knee or hip replacement surgery
- Patients who have had surgery on the lumbar, hip, knee, foot and ankle joints in the last 12 months
- Patients with a history of acute injury to the knee in the last 6 months
- Patients who have had steroid or hyaluronate injections in the knee in the last 6 months
- Patients with a body mass index of 40 kg/m2 or more
- Patients at risk for unsupervised physical activity
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Digital-based Physical Activity Intervention on Pain, Function and Exercise Adherence in Individuals With Knee Osteoarthritis: a Randomized Controlled Trial
Physical activity is recommended in the guidelines to improve pain and function in the treatment of knee OA, regardless of the severity of the disease, but still, patients rarely do enough physical activity. The choice of intervention to improve symptoms and disorders may be key to increasing the level of physical activity. Adapting physical activity to the patient's needs and preferences can improve compliance and outcomes. In a Delphi study, the only statement that received 100% support was stated as "Individualized exercise is an integral component of treatment for anyone with osteoarthritis". However, healthcare providers often recommend physical activity programs that do not place too much emphasis on the patient's preferences. The decision to engage in physical activity is multifactorial, and it is necessary to understand people's physical activity preferences better in order to increase participation and compliance.
Digital health interventions have the potential to address physical inactivity as they are accessible to a large part of the population and can be delivered with high efficiency at a low cost. By enabling patient education, support for self-management, motivation, follow-up, feedback and communication, it can prevent, cure or treat many chronic conditions. These features can increase patient motivation and encourage compliance with home exercises and physical activity. Digital behavior change interventions use digital technologies (such as websites, mobile apps, SMS or wearables) to promote and maintain health and have the potential to overcome many barriers compared to in-person programs by providing cost-effective, effective, and accessible information. No study has been found in Turkey examining digital interventions or walking programs that include behavior change techniques to increase physical activity in patients with knee osteoarthritis. Considering environmental, cultural and economic factors in this patient group in our society, we think that walking, which we think is the most appropriate physical activity method in terms of cost, accessibility and equipment, should be a permanent behavior.
Our aim in the study; To examine the effects of digitally assisted physical activity intervention on pain, functionality and exercise commitment in individuals with knee osteoarthritis.
Read the detailed description
Functional capacity and quality of life decrease in individuals with knee osteoarthritis (OA). This is due to loss of strength and physical inactivity caused by pain or fatigue. Increasing levels of physical activity have been shown to reduce these problems. Another reason why individuals with osteoarthritis have a lower level of physical activity than the general population may be the fear of moving with the thought of more pain. However, physical activity is recommended as a basic treatment for osteoarthritis (Shih, Hootman et al. 2006).
Physical activity is recommended in the guidelines to improve pain and function in the treatment of knee OA, regardless of the severity of the disease, but still, patients rarely do enough physical activity (Zhang, Moskowitz et al.
2008, Zhang, Doherty et al. 2010, Dunlop, Song et al. al. 2011). The choice of intervention to improve symptoms and disorders may be key to increasing the level of physical activity. Adapting physical activity to the patient's needs and preferences can improve compliance and outcomes. In a Delphi study, the only statement that received 100% support was stated as "Individualized exercise is an integral component of treatment for anyone with osteoarthritis" (French, Bennell et al. 2015). However, healthcare providers often recommend physical activity programs that do not place too much emphasis on the patient's preferences. The decision to engage in physical activity is multifactorial, and it is necessary to understand people's physical activity preferences better in order to increase participation and compliance (Holden, Nicholls et al. 2009, Dierckx, Deveugele et al. 2013, Pinto, Danilovich et al. 2017).
Digital health interventions have the potential to address physical inactivity as they are accessible to a large part of the population and can be delivered with high efficiency at a low cost (Iribarren, Cato et al. 2017). By enabling patient education, support for self-management, motivation, follow-up, feedback and communication, it can prevent, cure or treat many chronic conditions. These features can increase patient motivation and encourage compliance with home exercises and physical activity (Meier, Fitzgerald et al. 2013). Digital behavior change interventions use digital technologies (such as websites, mobile apps, SMS or wearables) to promote and maintain health and have the potential to overcome many barriers compared to in-person programs by providing cost-effective, effective, and accessible information. McCabe et al. 2018). No study has been found in Turkey examining digital interventions or walking programs that include behavior change techniques to increase physical activity in patients with knee osteoarthritis. Considering environmental, cultural and economic factors in this patient group in our society, we think that walking, which we think is the most appropriate physical activity method in terms of cost, accessibility and equipment, should be a permanent behavior. The use of technology to increase physical activity in the era of digitalization is important in terms of addressing the increasing inactivity during the Covid-19 pandemic period. Our aim in the study; To examine the effects of digitally assisted physical activity intervention on pain, functionality and exercise commitment in individuals with knee osteoarthritis.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Digital-based physical activity intervention, Patient education and exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital-based physical activity interventionBehavioural
The digital behavioral program comprises goal planning, motivational messages and video calls, social support, and routine follow-up of weekly goals.
Patient education and exerciseOther
Patient education will include information on osteoarthritis, prognosis, pain management, importance of physical activity and exercise. The exercise program will include warm up, stretching and strengthening.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental group will receive patient education, exercise, and digital-based physical activity intervention. Receives: Behavioral: Digital-based physical activity intervention; Other: Patient education and exercise |
| Control Group | Active comparator | Control group will receive patient education and exercise. Receives: Other: Patient education and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Pain will be measured using a 10 cm visual analogue scale (VAS). The participants places a mark on the line that best represented their perception of pain at that instant. The VAS score will be measured in cm from the left hand end of the line to the mark.
Measured: The pain will be measured at study entry (baseline) after inclusion.
Visual analogue scale (VAS)
Pain will be measured using a 10 cm visual analogue scale (VAS). The participants places a mark on the line that best represented their perception of pain at that instant. The VAS score will be measured in cm from the left hand end of the line to the mark.
Measured: The pain will be measured at the end of intervention (8. week).
Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index
The WOMAC osteoarthritis index is a 24-item scale that examines three dimensions: pain, stiffness, and physical function.
Each question is scored on a Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. The score of each section is calculated on its own and the total score ranges from 0 to 100. High scores indicate increased pain and stiffness and impaired physical function.
Measured: The WOMAC will be measured at baseline 2 minutes after pain assessment.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index
The WOMAC osteoarthritis index is a 24-item scale that examines three dimensions: pain, stiffness, and physical function.
Each question is scored on a Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. The score of each section is calculated on its own and the total score ranges from 0 to 100. High scores indicate increased pain and stiffness and impaired physical function.
Measured: The WOMAC will be measured at the end of intervention (8. week) 2 minutes after pain assessment.
Exercise adherence
In the exercise diary, the participant will note the number of steps he takes regularly and the number of exercises he does each day. Patients will be asked to note in their diaries any discomfort they experience in daily life, walking or exercising. The physiotherapist will follow the diaries of the participants included in the walking program assigned to the intervention group each week.
Measured: Exercise adherence will be measured at the end of intervention (8. week) 2 minutes after WOMAC assessment.
Secondary outcomes (2)
Step count
One week before the intervention, a smart watch will be delivered to the patients and the 1-week step counts will be recorded. Xiaomi Mi Band 3 Smart Wristband will be used for patients to follow their own steps and take notes in their diaries and reach the appropriate number of steps in line with the target given each week.
Measured: Step count will be measured at the week before study entry (baseline).
Step count
One week before the intervention, a smart watch will be delivered to the patients and the 1-week step counts will be recorded. Xiaomi Mi Band 3 Smart Wristband will be used for patients to follow their own steps and take notes in their diaries and reach the appropriate number of steps in line with the target given each week.
Measured: Step count will be measured at the 8. week at the end of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Akgul, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810376
- Sponsor's protocol ID
- 2021/291
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akgul H, Birtane M, Tonga E. Effects of a Digitally Supported Physical Activity Intervention in Knee Osteoarthritis: A Pilot Randomized Controlled Trial. Musculoskeletal Care. 2025 Jun;23(2):e70085. doi: 10.1002/msc.70085.
PubMed 40148223
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Digital-based Physical Activity Intervention on Pain, Function and Exercise Adherence in Individuals With Knee Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05810376
- Acronym / sponsor ID
- 2021/291
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 12 Apr 2023 (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.
Physical activity is recommended in the guidelines to improve pain and function in the treatment of knee OA, regardless of the severity of the disease, but still, patients rarely do enough physical activity. The choice of intervention to improve symptoms and disorders may be key to increasing the level of physical activity. Adapting physical activity to the patient's needs and preferences can improve compliance and outcomes. In a Delphi study, the only statement that received 100% support was stated as "Individualized exercise is an integral component of treatment for anyone with osteoarthritis". However, healthcare providers often recommend physical activity programs that do not place too much emphasis on the patient's preferences. The decision to engage in physical activity is multifactorial, and it is necessary to understand people's physical activity preferences better in order to increase participation and compliance.
Digital health interventions have the potential to address physical inactivity as they are accessible to a large part of the population and can be delivered with high efficiency at a low cost. By enabling patient education, support for self-management, motivation, follow-up, feedback and communication, it can prevent, cure or treat many chronic conditions. These features can increase patient motivation and encourage compliance with home exercises and physical activity. Digital behavior change interventions use digital technologies (such as websites, mobile apps, SMS or wearables) to promote and maintain health and have the potential to overcome many barriers compared to in-person programs by providing cost-effective, effective, and accessible information. No study has been found in Turkey examining digital interventions or walking programs that include behavior change techniques to increase physical activity in patients with knee osteoarthritis. Considering environmental, cultural and economic factors in this patient group in our society, we think that walking, which we think is the most appropriate physical activity method in terms of cost, accessibility and equipment, should be a permanent behavior.
Our aim in the study; To examine the effects of digitally assisted physical activity intervention on pain, functionality and exercise commitment in individuals with knee osteoarthritis.
Detailed description
Functional capacity and quality of life decrease in individuals with knee osteoarthritis (OA). This is due to loss of strength and physical inactivity caused by pain or fatigue. Increasing levels of physical activity have been shown to reduce these problems. Another reason why individuals with osteoarthritis have a lower level of physical activity than the general population may be the fear of moving with the thought of more pain. However, physical activity is recommended as a basic treatment for osteoarthritis (Shih, Hootman et al. 2006).
Physical activity is recommended in the guidelines to improve pain and function in the treatment of knee OA, regardless of the severity of the disease, but still, patients rarely do enough physical activity (Zhang, Moskowitz et al.
2008, Zhang, Doherty et al. 2010, Dunlop, Song et al. al. 2011). The choice of intervention to improve symptoms and disorders may be key to increasing the level of physical activity. Adapting physical activity to the patient's needs and preferences can improve compliance and outcomes. In a Delphi study, the only statement that received 100% support was stated as "Individualized exercise is an integral component of treatment for anyone with osteoarthritis" (French, Bennell et al. 2015). However, healthcare providers often recommend physical activity programs that do not place too much emphasis on the patient's preferences. The decision to engage in physical activity is multifactorial, and it is necessary to understand people's physical activity preferences better in order to increase participation and compliance (Holden, Nicholls et al. 2009, Dierckx, Deveugele et al. 2013, Pinto, Danilovich et al. 2017).
Digital health interventions have the potential to address physical inactivity as they are accessible to a large part of the population and can be delivered with high efficiency at a low cost (Iribarren, Cato et al. 2017). By enabling patient education, support for self-management, motivation, follow-up, feedback and communication, it can prevent, cure or treat many chronic conditions. These features can increase patient motivation and encourage compliance with home exercises and physical activity (Meier, Fitzgerald et al. 2013). Digital behavior change interventions use digital technologies (such as websites, mobile apps, SMS or wearables) to promote and maintain health and have the potential to overcome many barriers compared to in-person programs by providing cost-effective, effective, and accessible information. McCabe et al. 2018). No study has been found in Turkey examining digital interventions or walking programs that include behavior change techniques to increase physical activity in patients with knee osteoarthritis. Considering environmental, cultural and economic factors in this patient group in our society, we think that walking, which we think is the most appropriate physical activity method in terms of cost, accessibility and equipment, should be a permanent behavior. The use of technology to increase physical activity in the era of digitalization is important in terms of addressing the increasing inactivity during the Covid-19 pandemic period. Our aim in the study; To examine the effects of digitally assisted physical activity intervention on pain, functionality and exercise commitment in individuals with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Digital-based physical activity intervention, Other: Patient education and exerciseExperimental group will receive patient education, exercise, and digital-based physical activity intervention. |
| Control Group | Active comparator | Other: Patient education and exerciseControl group will receive patient education and exercise. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Knee Osteoarthritis* (ACR criteria)
- 50 years old or over 50 years old
- Pain or discomfort for a total of 28 days or more than 28 days on consecutive or separate days in the past year
- Patients with daily internet access will be included in the study.
Key exclusion criteria (8 listed)
- Patients with a previous diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica, connective tissue diseases, fibromyalgia or gout
- Patients with a history of using antirheumatic drugs or gout medications
- Patients who have had previous knee arthroplasty and are on the waiting list for total knee or hip replacement surgery
- Patients who have had surgery on the lumbar, hip, knee, foot and ankle joints in the last 12 months
- Patients with a history of acute injury to the knee in the last 6 months
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 |
|---|---|---|
| Digital-based physical activity interventionThe digital behavioral program comprises goal planning, motivational messages and video calls, social support, and routine follow-up of weekly goals. | Behavioural | Experimental Group |
| Patient education and exercisePatient education will include information on osteoarthritis, prognosis, pain management, importance of physical activity and exercise. The exercise program will include warm up, stretching and strengthening. | Other | Control Group, Experimental Group |
Primary outcome
Visual analogue scale (VAS)
Time frame: The pain will be measured at study entry (baseline) after inclusion.
Pain will be measured using a 10 cm visual analogue scale (VAS). The participants places a mark on the line that best represented their perception of pain at that instant. The VAS score will be measured in cm from the left hand end of the line to the mark.
Visual analogue scale (VAS)
Time frame: The pain will be measured at the end of intervention (8. week).
Pain will be measured using a 10 cm visual analogue scale (VAS). The participants places a mark on the line that best represented their perception of pain at that instant. The VAS score will be measured in cm from the left hand end of the line to the mark.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index
Time frame: The WOMAC will be measured at baseline 2 minutes after pain assessment.
The WOMAC osteoarthritis index is a 24-item scale that examines three dimensions: pain, stiffness, and physical function. Each question is scored on a Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. The score of each section is calculated on its own and the total score ranges from 0 to 100. High scores indicate increased pain and stiffness and impaired physical function.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index
Time frame: The WOMAC will be measured at the end of intervention (8. week) 2 minutes after pain assessment.
The WOMAC osteoarthritis index is a 24-item scale that examines three dimensions: pain, stiffness, and physical function. Each question is scored on a Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. The score of each section is calculated on its own and the total score ranges from 0 to 100. High scores indicate increased pain and stiffness and impaired physical function.
Exercise adherence
Time frame: Exercise adherence will be measured at the end of intervention (8. week) 2 minutes after WOMAC assessment.
In the exercise diary, the participant will note the number of steps he takes regularly and the number of exercises he does each day. Patients will be asked to note in their diaries any discomfort they experience in daily life, walking or exercising. The physiotherapist will follow the diaries of the participants included in the walking program assigned to the intervention group each week.
2 secondary outcomes
Step count
Time frame: Step count will be measured at the week before study entry (baseline).
Step count
Time frame: Step count will be measured at the 8. week at the end of intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 40148223Akgul H, Birtane M, Tonga E. Effects of a Digitally Supported Physical Activity Intervention in Knee Osteoarthritis: A Pilot Randomized Controlled Trial. Musculoskeletal Care. 2025 Jun;23(2):e70085. doi: 10.1002/msc.70085.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Digital-based physical activity intervention and Patient education and exercise in people with Osteoarthritis, Knee, run by Trakya University.
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 4 inclusion and 8 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Hakan Akgül, MSc (+905548039297, fzt.hakanakgul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: The pain will be measured at study entry (baseline) after inclusion.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05810376, which also lists 1 linked publication.
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 12 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.