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CompletedNCT05832866CB&HMInKOAUpdated May 3, 2023

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

An interventional study of Clinical Based Isometric contraction strengthening Exercises using Thera band and Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band in Knee Osteoarthritis, sponsored by Obafemi Awolowo University. Completed at 1 site in Nigeria. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Obafemi Awolowo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Feb 2021, registered Apr 2023).

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Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Knee osteoarthritis
  • Pain intensity
  • Functioning
  • Health Related Quality of Life
  • Tele-monitoring
03

In context

Osteoarthritis, Knee

3,294 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's enrollment of 42 is below the median of 68 across 2,716 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Obafemi Awolowo University is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
42 participants (actual)

Study arms

  • 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 · Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band

  • 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 · Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band

Interventions

  • OtherClinical 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

    Also known as: Clinical Based intervention

  • OtherTelemonitored 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

    Also known as: Telemonitores Home based Intervention

06

What researchers measure

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

    Time frame: 1-8 weeks

Secondary outcomes

  1. 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

    Time frame: 1-8 weeks

07

Study locations

1 site
  • Obafemi Awolowo University,
    Ile Ife, Osun 220005, Nigeria
08

References and documents

Publications

  • 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. PubMed 21248209 ↗
  • 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. PubMed 21812903 ↗
  • 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. PubMed 30018942 ↗

Individual participant data

Plan to share: Undecided — The plan to share the IPD later

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2021 to primary completion in Sep 2021, 7 months.

Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 7 months is below that.

Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2023
First posted
Apr 27, 2023
StartActual
Feb 12, 2021
Primary completionActual
Sep 14, 2021
CompletionActual
Oct 23, 2021
Last update
May 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05832866
Lead sponsor
Obafemi Awolowo University
Responsible party
Adesola Ojo Ojoawo (Professor, Obafemi Awolowo University) — Principal investigator
First posted
Apr 27, 2023
Start date
Feb 12, 2021
Primary completion
Sep 14, 2021
Completion
Oct 23, 2021
Last update
May 3, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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