Clinic-based and Tele-monitored Home-based Intervention in Patients With Knee OA

Study Overview
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Brief Summary
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This study assessed and compared the effects of clinic-based and telemonitored home-based interventions on pain intensity, function and quality of life in patients with knee osteoarthritis (KOA). This was with a view to providing evidence for the validation of the effectiveness of home-based intervention on knee osteoarthritis

Detailed Description
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This study was a quasi-experiment involving forty two patients with KOA. They were randomly allocated into two groups equally; clinic-based group (CBG) and telemonitored home-based group (THG). The CBG received exercises to strengthen the quadriceps and hamstring muscles using thera band while THG received same treatment regimen but at home and were monitored on phone by the researcher. The subjects performed four sets of eight repetitions for each of the exercises three days in a week for eight weeks. Pain intensity was assessed with Quadruple Visual Analog Scale, function was assessed with the Western Ontario and McMaster University Osteoarthritis Index and quality of life was assessed with WHO Quality of Life-BREF at pretreatment, 3rd week, 6th week and 8th week of intervention. Data was analysed with descriptive and inferential statistics. Repeated measure ANOVA was used to compare the mean value of variables within the group and between the groups. Alpha level was set at 0.05.

Official Title
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Effect of Clinic-based and Tele-monitored Home-based Intervention on Pain Intensity, Function and Quality of Life in Patients With Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Clinical Based Isometric contraction strengthening Exercises using Thera band
* Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with osteoarthritis of the knee of not less than six weeks. Patients that have means of communication via mobile telephone. Patients who understands English or Yoruba Language. Exclusion Criteria: Participants that have any other knee joint diseases. Participants with history of knee joint trauma. Participants with history of knee surgery or arthroplasty

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There were two groups, one with clinical based and the other with telemonitored home based. The two groups received thera band exercises of isometric contractions. The clinical based at the hospital, and the home based at home but being monitored by researcher with phone call.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical Based Isometric contraction strengthening Exercises using Thera band CBG<br>Participants underwent strengthening exercises to the quadriceps and harmstring using thera band at the hospital. The band was attached around the ankle for strengthening of the quadriceps and hamstring muscles using isometric muscle contraction using a standard protocol. The patient performed four sets of eight repetitions for each of the exercises. | Other: Clinical Based Isometric contraction strengthening Exercises using Thera band<br>* Patients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone<br>* Other names: Clinical Based intervention;Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band<br>* Patients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks<br>* Other names: Telemonitores Home based Intervention;|
| Experimental: Telemonitored Home based Isometric Contraction strengthening exercises using Thera band THB<br>Participants underwent strengthening exercises to the quadriceps and harmstrings with thera band but doing the intervention at home but monitored with telephone call. The band was attached around the ankle for strengthening of the quadriceps and hamstring muscles using isometric muscle contraction using a standard protocol. The patient performed four sets of eight repetitions for each of the exercises. | Other: Clinical Based Isometric contraction strengthening Exercises using Thera band<br>* Patients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone<br>* Other names: Clinical Based intervention;Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band<br>* Patients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks<br>* Other names: Telemonitores Home based Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadruple Visual Analog Scale (QVAS) | This was used to assess pain intensity experienced by the participants at the time of assessment, typical or average pain, pain at its best, and pain at its worst, respectively (Von Korff et al, 1993).It consists of 4 items with each item numbered 0 to 10. With 0 indicating no pain and 10 is worst possible pain. A Yoruba translated version of the QVAS was used for participants who had preference for the Yoruba language | 1-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Western Ontario and McMaster Universities Osteoarthritis Index | WOMAC is a self-administered health-status instrument for patients with KOA, consists of 24 items within three subscales: pain (5 items), stiffness (2 items) and physical function (17 items). The Yoruba version of WOMAC translated was used for participants who do not understand English. Minimum is 0 and maxmum is 4 | 1-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee osteoarthritis, Pain intensity, Functioning, Health Related Quality of Life, Tele-monitoring