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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Clinical Based Isometric contraction strengthening Exercises using Thera band
Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band
Sponsored by
Obafemi Awolowo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Pain intensity, Functioning, Health Related Quality of Life, Tele-monitoring

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Obafemi Awolowo University,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Clinical Based Isometric contraction strengthening Exercises using Thera band" CBG

Telemonitored Home based Isometric Contraction strengthening exercises using Thera band" THB

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 16, 2023
Last Updated
April 28, 2023
Sponsor
Obafemi Awolowo University
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1. Study Identification

Unique Protocol Identification Number
NCT05832866
Brief Title
Clinic-based and Tele-monitored Home-based Intervention in Patients With Knee OA
Acronym
CB&HMInKOA
Official Title
Effect of Clinic-based and Tele-monitored Home-based Intervention on Pain Intensity, Function and Quality of Life in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
September 14, 2021 (Actual)
Study Completion Date
October 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Obafemi Awolowo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, Pain intensity, Functioning, Health Related Quality of Life, Tele-monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
There was no masking in the intervention
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical Based Isometric contraction strengthening Exercises using Thera band" CBG
Arm Type
Experimental
Arm Description
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.
Arm Title
Telemonitored Home based Isometric Contraction strengthening exercises using Thera band" THB
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical Based Isometric contraction strengthening Exercises using Thera band
Other Intervention Name(s)
Clinical Based intervention
Intervention Description
Patients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone
Intervention Type
Other
Intervention Name(s)
Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band
Other Intervention Name(s)
Telemonitores Home based Intervention
Intervention Description
Patients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks
Primary Outcome Measure Information:
Title
Quadruple Visual Analog Scale (QVAS)
Description
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
Time Frame
1-8 weeks
Secondary Outcome Measure Information:
Title
The Western Ontario and McMaster Universities Osteoarthritis Index
Description
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
Time Frame
1-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Obafemi Awolowo University,
City
Ile Ife
State/Province
Osun
ZIP/Postal Code
220005
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The plan to share the IPD later
Citations:
PubMed Identifier
21248209
Citation
Russell TG, Buttrum P, Wootton R, Jull GA. Internet-based outpatient telerehabilitation for patients following total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2011 Jan 19;93(2):113-20. doi: 10.2106/JBJS.I.01375.
Results Reference
background
PubMed Identifier
21812903
Citation
Runhaar J, Koes BW, Clockaerts S, Bierma-Zeinstra SM. A systematic review on changed biomechanics of lower extremities in obese individuals: a possible role in development of osteoarthritis. Obes Rev. 2011 Dec;12(12):1071-82. doi: 10.1111/j.1467-789X.2011.00916.x. Epub 2011 Aug 3.
Results Reference
background
PubMed Identifier
30018942
Citation
Ojoawo AO, Malomo EO, Olusegun EO, Olaogun BMO. Effects of pulse ultrasound and kneading massage in managing individual with incessant pain at lower region of back using random allocation. J Exerc Rehabil. 2018 Jun 30;14(3):516-522. doi: 10.12965/jer.1836126.063. eCollection 2018 Jun.
Results Reference
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Clinic-based and Tele-monitored Home-based Intervention in Patients With Knee OA

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