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

NCT05810376 | Unknown

• 1 other identifier: 2021/291
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (5)

• 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.

• 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).

• 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.

• 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.

• 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 Outcomes (2)

• Step count

  Step count will be measured at the week before study entry (baseline).

• Step count

  Step count will be measured at the 8. week at the end of intervention.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Behavioral: Digital-based physical activity intervention; Other: Patient education and exercise

Control Group

ACTIVE COMPARATOR

Control group will receive patient education and exercise.

Other: Patient education and exercise

Interventions

Digital-based physical activity intervention BEHAVIORAL

The digital behavioral program comprises goal planning, motivational messages and video calls, social support, and routine follow-up of weekly goals.

Experimental Group

Patient education and exercise OTHER

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Knee Osteoarthritis\* (ACR criteria)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Related Publications (1)

• 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.

  PMID: 40148223 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Patient Education as Topic; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Hakan Akgül, MSc

CONTACT

+905548039297; fzt.hakanakgul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share