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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Clinical Based Isometric contraction strengthening Exercises using Thera band; Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band

• Registration Number: NCT05832866
• Lead Sponsor: Obafemi Awolowo University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-02-12
• Primary Completion: 2021-09-14
• Study Completion: 2021-10-23
• Status Verified: 2023-04
• Study First Submitted: 2023-04-16
• Study First Submitted QC: 2023-04-16
• Study First Posted: 2023-04-27
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitored Home based Isometric Contraction strengthening exercises using Thera band" THB	Clinical Based Isometric contraction strengthening Exercises using Thera band	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.
Clinical Based Isometric contraction strengthening Exercises using Thera band" CBG	Clinical Based Isometric contraction strengthening Exercises using Thera band	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.
Telemonitored Home based Isometric Contraction strengthening exercises using Thera band" THB	Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band	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.
Clinical Based Isometric contraction strengthening Exercises using Thera band" CBG	Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band	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.

Primary Outcome Measures

Name	Time	Method
Quadruple Visual Analog Scale (QVAS)	1-8 weeks	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

Secondary Outcome Measures

Name	Time	Method
The Western Ontario and McMaster Universities Osteoarthritis Index	1-8 weeks	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

Trial Locations

Locations (1)

Obafemi Awolowo University,; 🇳🇬 Ile Ife, Osun, Nigeria