search
Back to results

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

Primary Purpose

Osteoarthritis, Knee

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Digital-based physical activity intervention
Patient education and exercise
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental Group

    Control Group

    Arm Description

    Experimental group will receive patient education, exercise, and digital-based physical activity intervention.

    Control group will receive patient education and exercise.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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
    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.

    Full Information

    First Posted
    March 30, 2023
    Last Updated
    March 30, 2023
    Sponsor
    Trakya University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05810376
    Brief Title
    Effects of Digital-based Physical Activity Intervention in Individuals With Knee Osteoarthritis
    Official Title
    Effects of Digital-based Physical Activity Intervention on Pain, Function and Exercise Adherence in Individuals With Knee Osteoarthritis: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Trakya University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    Experimental group will receive patient education, exercise, and digital-based physical activity intervention.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Control group will receive patient education and exercise.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Digital-based physical activity intervention
    Intervention Description
    The digital behavioral program comprises goal planning, motivational messages and video calls, social support, and routine follow-up of weekly goals.
    Intervention Type
    Other
    Intervention Name(s)
    Patient education and exercise
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Visual analogue scale (VAS)
    Description
    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.
    Time Frame
    The pain will be measured at study entry (baseline) after inclusion.
    Title
    Visual analogue scale (VAS)
    Description
    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.
    Time Frame
    The pain will be measured at the end of intervention (8. week).
    Title
    Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index
    Description
    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.
    Time Frame
    The WOMAC will be measured at baseline 2 minutes after pain assessment.
    Title
    Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index
    Description
    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.
    Time Frame
    The WOMAC will be measured at the end of intervention (8. week) 2 minutes after pain assessment.
    Title
    Exercise adherence
    Description
    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.
    Time Frame
    Exercise adherence will be measured at the end of intervention (8. week) 2 minutes after WOMAC assessment.
    Secondary Outcome Measure Information:
    Title
    Step count
    Description
    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.
    Time Frame
    Step count will be measured at the week before study entry (baseline).
    Title
    Step count
    Description
    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.
    Time Frame
    Step count will be measured at the 8. week at the end of intervention.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hakan Akgül, MSc
    Phone
    +905548039297
    Email
    fzt.hakanakgul@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs