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Completed

NCT Number: NCT04159883

The Effect of Using Smart Phone Application for Enhancing Adherence to Home Exercise

Background: Knee osteoarthritis (OA) is a serious condition and requires good adherence to interventions such as exercises to achieve optimal management. The use of smart phone technologies could be such a strategy to enhance adherence to the home exercise program (HEP) thus improve pain, physical function and lower limb strength. The study aimed to examine the effect of using an innovative smart phone app on enhancing the adherence to home exercise programs among female older adults with knee OA in Saudi Arabia and the effectiveness of this HEP which delivered through an app, on pain and physical function. Methodology: 40 females aged 50 years or older with knee OA (20 per study arm) recruited to a randomized control trial that uses a parallel study design. All participants assessed and received an education and a set of a home exercise program for knee OA, Participants randomized into the App arm (experimental group) received their HEP in the smart phone application. Participants randomized to the other arm (control group) received HEP in a paper hand-out. After enrolment, the study outcomes were assessed at week three and week six. The primary outcomes were self-reported adherence, ANPRS, and Ar-WOMAC.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

King Saud University

Riyadh, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female older adults aged 50 and above.
  • Diagnosed with unilateral or bilateral chronic knee OA (diagnosed ≥ six months).
  • Mild to moderate pain intensity (score ≤ 7 on the Arabic Numeric Pain Rating Scale).
  • Ambulate independently.
  • Literate, familiar to use smart mobile phone or tablet.
  • No previous exercising within the last six months.

Exclusion criteria

  • Comorbidities that affect their health and wellness (neurological conditions, unstable cardiopulmonary conditions, mental disorders with score < 24 on Mini-Mental State Examination)
  • Waiting for surgical intervention.
  • Recent trauma (fall/ accident).

Treatment and study plan

strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles)

Other

Simple progressive strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles), the program has been evident to be significantly effective in improving self-reported knee pain and function. This program included: 1) Isometric quadriceps contraction, 2) Isotonic quadriceps contraction, 3) Isotonic hamstring contraction, 4) Isotonic quadriceps contraction with resistance band, 5), straight leg raising, 6) Side-lying hip abduction, 7) Partial Squats,

"My Dear Knee" smart phone application

Other

The innovative app has been designed for Android and iPhone Operating System (iOS). The app provides guides with the Arabic language. It designed to be attractive for the older adult and easy to use. the exercises are demonstrated with colorful animated images to make easy to follow by the patients.

The app supports features such as alerts, monitoring system by the physical therapist and remote follow-up. The app provides automatic recording of exercise adherence, including the time and the number of sessions completed for the week in the physical therapist's account.

Primary outcomes

  1. The self-reported adherence

    Time frame: 6 weeks

    Adherence rate obtained as a percentage of the exercise done out of the total number of prescribed exercises. The self-reported adherence is a self-report, all the participants received an exercise log and asked to check on the date of the completed exercise. To calculate adherence, the total number of done exercises for each participant was divided by 84 and 182, which were the total number of prescribed exercises for the 3rd and 6th week period respectively.

  2. The Arabic Numeric Pain Rating Scale (ANPRS)

    Time frame: Change from baseline pain score at 6 weeks

    Pain intensity over the previous week evaluated with The Arabic Numeric Pain Rating Scale (ANPRS) which is a reliable and valid scale for assessing pain in knee osteoarthritis. It is a 0 to 10 numerical rating scale in which "0" indicates "no pain" and "10" indicates "worst pain".

  3. The Arabic version of the reduced WOMAC index (ArWOMAC)- Function sub-scale

    Time frame: Change from baseline functional score at 6 weeks

    Used to assess the physical function. It is reliable and valid measure for assessing the severity of knee OA in term of pain and physical function. The reduced ArWOMAC has two subscales and twelve elements in total, the pain subscale includes five elements and the physical function subscale includes seven elements. Likert-scale is applied where the response of each element comes with five levels showing varying intensity degrees that range from 0 to 4, where four is assigned for "extreme" and 0 assigned for "none". The analysis entails collecting and summing up the scores for elements in both subscales to get the total scores (for pain 0-20, for function the scores are 0-28

Secondary outcomes

  1. The Five-Times Sit-To-Stand Test (FTSST)

    Time frame: Change from baseline strength score at 6 weeks

    To evaluate lower-limb muscle strength, the five-times sit-to-stand test used. It is a part of the Short Physical Performance Battery instrument; it is simple, fast, inexpensive and reproducible. It is valid (115) and has excellent test-retest reliability for older adults in general and osteoarthritic older adults. The test utilized an armless chair; the seat rises 46 cm above the ground. The participant starts out by sitting on the chair with arms crossed over the chest. Awarding points is a function of the required time to complete the test. The contributor takes 4 points for the time, not exceeding 11.19 seconds; 3 points when the consumed time is greater than 11.20 and less than 13.69 seconds; two points when the required time ranges from 13.70 and 16.69 seconds; one point if the consumed time is greater than 16.7 seconds; 0 points if the participant cannot complete the test or need more than 60 seconds to finish it.

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

The Effect of Using Smart Phone Application for Enhancing Adherence to Home Exercise Program Among Older Adults With Knee Osteoarthritis in Saudi Arabia

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 12, 2019
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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