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

NCT04159883 | Completed

• 1 other identifier: 437203559
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• The self-reported adherence

  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.

  6 weeks

• The Arabic Numeric Pain Rating Scale (ANPRS)

  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".

  Change from baseline pain score at 6 weeks

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

  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

  Change from baseline functional score at 6 weeks

Secondary Outcomes (1)

• The Five-Times Sit-To-Stand Test (FTSST)

  Change from baseline strength score at 6 weeks

Study Arms (2)

app

EXPERIMENTAL

For the App group, we installed the app from the store in their smart phone or tablets, made their account using the same email they use in their smart phone store. the participant was informed if they cannot follow the animated image in the app, they can re-launch the program and start to follow.

Other: strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles); Other: "My Dear Knee" smart phone application

paper

ACTIVE COMPARATOR

For the paper group, the participants were provided with a hard copy of the exercise program; we gave one paper of all nine exercises.

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

Interventions

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,

app; paper

"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.

app

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyadh, Saudi Arabia

Location

Related Publications (1)

• Alasfour M, Almarwani M. The effect of innovative smartphone application on adherence to a home-based exercise programs for female older adults with knee osteoarthritis in Saudi Arabia: a randomized controlled trial. Disabil Rehabil. 2022 Jun;44(11):2420-2427. doi: 10.1080/09638288.2020.1836268. Epub 2020 Oct 25.

  PMID: 33103499 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Maha Almarwani, PhD

  King Saud University

  STUDY DIRECTOR

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: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 12, 2019
• Study Start: November 14, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)