Knee OsteoarthritisNCT04159883
The Effect of Using Smart Phone Application for Enhancing Adherence to Home Exercise
A study testing strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles) and "My Dear Knee" smart phone application in people with Knee Osteoarthritis, run by King Saud University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles) and "My Dear Knee" smart phone application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 14 Nov 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles), "My Dear Knee" smart phone application
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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
Measured: Change from baseline functional score at 6 weeks
Secondary outcomes (1)
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.
Measured: Change from baseline strength score at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start14 Nov 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Mohammed Alasfour, King Saud University
- Investigators
- Maha Almarwani, PhD, Study director, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159883
- Sponsor's protocol ID
- 437203559
- Status last verified
- Aug 2020
- First submitted
- 6 Nov 2019
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be kept secure with the principal investigator (Mrs. Maryam Alasfour) and sub-investigator (Dr. Maha Almarwani) due to confidentiality issues
Publications
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.
PubMed 33103499
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04159883
- Acronym / sponsor ID
- 437203559
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| app | Experimental | Other: strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles), Other: "My Dear Knee" smart phone applicationFor 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. |
| paper | Active comparator | Other: strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles)For the paper group, the participants were provided with a hard copy of the exercise program; we gave one paper of all nine exercises. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles)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, | Other | app, paper |
| "My Dear Knee" smart phone applicationThe 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. | Other | app |
Primary outcome
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
1 secondary outcome
The Five-Times Sit-To-Stand Test (FTSST)
Time frame: Change from baseline strength score at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Derived from this study: PubMed 33103499Alasfour 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.
- Individual participant dataSharing planned: No. Data will be kept secure with the principal investigator (Mrs. Maryam Alasfour) and sub-investigator (Dr. Maha Almarwani) due to confidentiality issues
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha Almarwani, PhD study director
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles) and "My Dear Knee" smart phone application in people with Knee Osteoarthritis, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The self-reported adherence (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04159883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.