Clinic-based and Tele-monitored Home-based Intervention in Patients With Knee OA (CB&HMInKOA)

April 28, 2023 updated by: Adesola Ojo Ojoawo, Obafemi Awolowo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Osun
      • Ile Ife, Osun, Nigeria, 220005
        • Obafemi Awolowo University,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical Based Isometric contraction strengthening Exercises using Thera band" CBG
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
Patients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone
Other Names:
  • Clinical Based intervention
Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band
Patients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks
Other Names:
  • Telemonitores Home based Intervention
Experimental: Telemonitored Home based Isometric Contraction strengthening exercises using Thera band" THB
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
Patients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone
Other Names:
  • Clinical Based intervention
Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band
Patients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks
Other Names:
  • Telemonitores Home based Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadruple Visual Analog Scale (QVAS)
Time Frame: 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
1-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: 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
1-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Obafemi Awolowo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2021

Primary Completion (Actual)

September 14, 2021

Study Completion (Actual)

October 23, 2021

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

April 16, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ojoawo23/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan to share the IPD later

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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