Knee OsteoarthritisCB&HMInKOANCT05832866
Clinic-based and Tele-monitored Home-based Intervention in Patients With Knee OA
A study testing Clinical Based Isometric contraction strengthening Exercises using Thera band and Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band in people with Knee Osteoarthritis, run by Obafemi Awolowo University at 1 site in Nigeria.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Clinical Based Isometric contraction strengthening Exercises using Thera band and Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNigeria
- Study dates
- 12 Feb 2021to 23 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants that have any other knee joint diseases.
- Participants with history of knee joint trauma.
- Participants with history of knee surgery or arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Clinical Based Isometric contraction strengthening Exercises using Thera band, Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band
- Keywords
- Knee osteoarthritis, Pain intensity, Functioning, Health Related Quality of Life, Tele-monitoring
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Based Isometric contraction strengthening Exercises using Thera bandOther
Also called Clinical Based intervention
Patients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone
Telemonitored Home based Isometric Cntraction strengthening exercises using Thera bandOther
Also called Telemonitores Home based Intervention
Patients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical Based Isometric contraction strengthening Exercises using Thera band; Other: 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. Receives: Other: Clinical Based Isometric contraction strengthening Exercises using Thera band; Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start12 Feb 2021
- Primary completion14 Sep 2021
- Study completion23 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adesola Ojo Ojoawo, Obafemi Awolowo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832866
- Sponsor's protocol ID
- Ojoawo23/01
- Acronym
- CB&HMInKOA
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share the IPD later
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 21248209Runhaar 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 21812903Ojoawo 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
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05832866
- Acronym / sponsor ID
- CB&HMInKOA / Ojoawo23/01
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Pain intensity, Functioning, Health Related Quality of Life, Tele-monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Obafemi Awolowo UniversityUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 23 Oct 2021 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clinical Based Isometric contraction strengthening Exercises using Thera band" CBG | Experimental | Other: Clinical Based Isometric contraction strengthening Exercises using Thera band, Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera bandParticipants 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 | Experimental | Other: Clinical Based Isometric contraction strengthening Exercises using Thera band, Other: Telemonitored Home based Isometric Cntraction strengthening exercises using Thera bandParticipants 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Participants that have any other knee joint diseases.
- Participants with history of knee joint trauma.
- Participants with history of knee surgery or arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Based Isometric contraction strengthening Exercises using Thera bandAlso: Clinical Based interventionPatients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone | Other | Clinical Based Isometric contraction strengthening Exercises using Thera band" CBG, Telemonitored Home based Isometric Contraction strengthening exercises using Thera band" THB |
| Telemonitored Home based Isometric Cntraction strengthening exercises using Thera bandAlso: Telemonitores Home based InterventionPatients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks | Other | Clinical Based Isometric contraction strengthening Exercises using Thera band" CBG, Telemonitored Home based Isometric Contraction strengthening exercises using Thera band" THB |
Primary outcome
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 secondary outcome
The Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 1-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 21248209Russell 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.
- Background: PubMed 21812903Runhaar 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.
- Background: PubMed 30018942Ojoawo 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.
- Individual participant dataSharing planned: Undecided. The plan to share the IPD later
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Based Isometric contraction strengthening Exercises using Thera band and Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band in people with Knee Osteoarthritis, run by Obafemi Awolowo University at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadruple Visual Analog Scale (QVAS) (time frame: 1-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05832866, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.