Effects of Digital-based Physical Activity Intervention in Individuals With Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Effects of Digital-based Physical Activity Intervention on Pain, Function and Exercise Adherence in Individuals With Knee Osteoarthritis: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05810376
• Other study ID #: 2021/291
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2023
• Source: Trakya University
• Contact: Hakan Akgül, MSc
• Phone: +905548039297
• Email: fzt.hakanakgul[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Digital-based physical activity intervention
The digital behavioral program comprises goal planning, motivational messages and video calls, social support, and routine follow-up of weekly goals.

Other:
• Patient education and exercise
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The pain will be measured at study entry (baseline) after inclusion.
Primary	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.	The pain will be measured at the end of intervention (8. week).
Primary	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.	The WOMAC will be measured at baseline 2 minutes after pain assessment.
Primary	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.	The WOMAC will be measured at the end of intervention (8. week) 2 minutes after pain assessment.
Primary	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.	Exercise adherence will be measured at the end of intervention (8. week) 2 minutes after WOMAC assessment.
Secondary	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.	Step count will be measured at the week before study entry (baseline).
Secondary	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.	Step count will be measured at the 8. week at the end of intervention.