NCT05832866

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

April 16, 2023

Last Update Submit

April 28, 2023

Conditions

Keywords

Knee osteoarthritisPain intensityFunctioningHealth Related Quality of LifeTele-monitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Western Ontario and McMaster Universities Osteoarthritis Index

    1-8 weeks

Study Arms (2)

Clinical Based Isometric contraction strengthening Exercises using Thera band" CBG

EXPERIMENTAL

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 bandOther: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band

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

EXPERIMENTAL

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 bandOther: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band

Interventions

Patients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone

Also known as: Clinical Based intervention
Clinical Based Isometric contraction strengthening Exercises using Thera band" CBGTelemonitored Home based Isometric Contraction strengthening exercises using Thera band" THB

Patients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks

Also known as: Telemonitores Home based Intervention
Clinical Based Isometric contraction strengthening Exercises using Thera band" CBGTelemonitored Home based Isometric Contraction strengthening exercises using Thera band" THB

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants that have any other knee joint diseases.
  • Participants with history of knee joint trauma.
  • Participants with history of knee surgery or arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obafemi Awolowo University,

Ile-Ife, Osun State, 220005, Nigeria

Location

Related Publications (3)

  • 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.

    PMID: 21248209BACKGROUND
  • 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.

    PMID: 21812903BACKGROUND
  • 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.

    PMID: 30018942BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
There was no masking in the intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2023

First Posted

April 27, 2023

Study Start

February 12, 2021

Primary Completion

September 14, 2021

Study Completion

October 23, 2021

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations