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Clinical Trials/NCT04159883
NCT04159883
Completed
Not Applicable

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

King Saud University1 site in 1 country40 target enrollmentNovember 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
King Saud University
Enrollment
40
Locations
1
Primary Endpoint
The self-reported adherence
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 14, 2019
End Date
March 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maryam Mohammed Alasfour

Principal Investigator

King Saud University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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.

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".

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

  • The Five-Times Sit-To-Stand Test (FTSST)(Change from baseline strength score at 6 weeks)

Study Sites (1)

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