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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles)
"My Dear Knee" smart phone application
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • King Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

app

paper

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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".
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

Secondary Outcome Measures

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

Full Information

First Posted
November 6, 2019
Last Updated
August 31, 2020
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT04159883
Brief Title
The Effect of Using Smart Phone Application for Enhancing Adherence to Home Exercise
Official Title
The Effect of Using Smart Phone Application for Enhancing Adherence to Home Exercise Program Among Older Adults With Knee Osteoarthritis in Saudi Arabia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
app
Arm Type
Experimental
Arm Description
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.
Arm Title
paper
Arm Type
Active Comparator
Arm Description
For the paper group, the participants were provided with a hard copy of the exercise program; we gave one paper of all nine exercises.
Intervention Type
Other
Intervention Name(s)
strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles)
Intervention Description
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,
Intervention Type
Other
Intervention Name(s)
"My Dear Knee" smart phone application
Intervention Description
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 Outcome Measure Information:
Title
The self-reported adherence
Description
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.
Time Frame
6 weeks
Title
The Arabic Numeric Pain Rating Scale (ANPRS)
Description
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".
Time Frame
Change from baseline pain score at 6 weeks
Title
The Arabic version of the reduced WOMAC index (ArWOMAC)- Function sub-scale
Description
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
Time Frame
Change from baseline functional score at 6 weeks
Secondary Outcome Measure Information:
Title
The Five-Times Sit-To-Stand Test (FTSST)
Description
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.
Time Frame
Change from baseline strength score at 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha Almarwani, PhD
Organizational Affiliation
King Saud University
Official's Role
Study Director
Facility Information:
Facility Name
King Saud University
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be kept secure with the principal investigator (Mrs. Maryam Alasfour) and sub-investigator (Dr. Maha Almarwani) due to confidentiality issues
Citations:
PubMed Identifier
33103499
Citation
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.
Results Reference
derived

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

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