- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04159883
The Effect of Using Smart Phone Application for Enhancing Adherence to Home Exercise
The Effect of Using Smart Phone Application for Enhancing Adherence to Home Exercise Program Among Older Adults With Knee Osteoarthritis in Saudi Arabia
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Riyadh, Saudi Arabia
- King Saud University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: app
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.
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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,
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. |
ACTIVE_COMPARATOR: paper
For the paper group, the participants were provided with a hard copy of the exercise program; we gave one paper of all nine exercises.
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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,
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The self-reported adherence
Time Frame: 6 weeks
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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.
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6 weeks
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The Arabic Numeric Pain Rating Scale (ANPRS)
Time Frame: Change from baseline pain score at 6 weeks
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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".
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Change from baseline pain score at 6 weeks
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The Arabic version of the reduced WOMAC index (ArWOMAC)- Function sub-scale
Time Frame: Change from baseline functional score at 6 weeks
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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
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Change from baseline functional score at 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Five-Times Sit-To-Stand Test (FTSST)
Time Frame: Change from baseline strength score at 6 weeks
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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.
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Change from baseline strength score at 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maha Almarwani, PhD, King Saud University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 437203559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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