Knee OsteoarthritisNCT04227860
Balance and Strength Exercise in Knee Osteoarthritis Patients
A study testing Balance exercise program and Strengthening exercise program in people with Knee Osteoarthritis, run by University of Alexandria at 1 site in Egypt.
Trial summary
The aim of this study is to assess the effect of balance exercise on dynamic balance and physical function in 80 patients with different grades of primary knee osteoarthritis (KOA). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Balance exercise program and Strengthening exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2020to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary knee osteoarthritis according to the EULAR recommendations 2010.
- Patients can complete at least stage 1 of balance and exercise program (minimum of 2 weeks)
Who cannot join
- Patients that cannot complete at least stage 1 of balance and exercise program
- Patients with medical conditions affecting postural balance including visual, inner ear and neurological problems.
- Patients with lower limb joint or bony problems other than primary knee osteoarthritis .
- Patients with secondary KOA.
- Patients who received intra- articular joint injection in 1 or both knees in the past 90 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Combined Balance and Strength Exercise Program in Patients With Different Grades of Primary Knee Osteoarthritis Patients
The aim of this study is to assess the effect of balance exercise on dynamic balance and physical function in 80 patients with different grades of primary knee osteoarthritis (KOA).
Read the detailed description
The study will include 80 patients with primary knee osteoarthritis divided into 4 groups according to the Kellgren and Lawrence grading scale (KL):
Group 1: 20 patients with grade I KOA Group 2: 20 patients with grade II KOA Group 3: 20 patients with grade III KOA Group 4: 20 patients with grade IV KOA
- Patients will undergo pre-exercise and post- exercise assessment with:
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
- Modified Stare Excursion Balance test
- Timed up and Go test
- Exercise program includes:
- Lower extremity kinesthesia and balance exercise program
- Strength exercise program
- Conditions
- Knee Osteoarthritis
- Being tested
- Balance exercise program, Strengthening exercise program
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance exercise programOther
Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks.
Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.
Strengthening exercise programOther
Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks.
Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: G I primary KOA | Active comparator | Exercise and balance training Receives: Other: Balance exercise program; Other: Strengthening exercise program |
| Group 2: G II primary KOA | Active comparator | Exercise and balance training Receives: Other: Balance exercise program; Other: Strengthening exercise program |
| Group 3: G III primary KOA | Active comparator | Exercise and balance training Receives: Other: Balance exercise program; Other: Strengthening exercise program |
| Group 4: G IV primary KOA | Active comparator | Exercise and balance training Receives: Other: Balance exercise program; Other: Strengthening exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain
Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains pain sub-score and a overall total score. The higher the score the worst the pain.
Measured: 2-6 weeks
Assessment of stiffness
Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains stiffness sub-score and a overall total score. The higher the score the worst the stiffness.
Measured: 2-6 weeks
Assessment of physical function
Using the time up and go test, where the patient is seated and asked to get up walk a distance turn around and return to chair and sit again. It is measured using a timer, the longer the patient takes the worst the physical function of the patient.
Measured: 2-6 weeks
Secondary outcomes (1)
Dynamic Balance
Using the Modified star excursion balance test which measures the patients dynamic balance in several directions, giving the patient 3 attempts and measuring each time and taking a mean of the 3 measurements in each. An increase in the measurements means better dynamic balance and a smaller measurement means worse dynamic balance.
Measured: 2-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start20 Jan 2020
- Primary completion1 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra Hisham Abdel Fattah, University of Alexandria
- Investigators
- Yousra H Abdel Fattah, Principal investigator, Alexandria University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227860
- Sponsor's protocol ID
- 0105852
- Status last verified
- May 2022
- First submitted
- 9 Jan 2020
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Balance and Strength Exercise Program in Patients With Different Grades of Primary Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT04227860
- Acronym / sponsor ID
- 0105852
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Jan 2020 (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.
The aim of this study is to assess the effect of balance exercise on dynamic balance and physical function in 80 patients with different grades of primary knee osteoarthritis (KOA).
Detailed description
The study will include 80 patients with primary knee osteoarthritis divided into 4 groups according to the Kellgren and Lawrence grading scale (KL):
Group 1: 20 patients with grade I KOA Group 2: 20 patients with grade II KOA Group 3: 20 patients with grade III KOA Group 4: 20 patients with grade IV KOA
- Patients will undergo pre-exercise and post- exercise assessment with:
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
- Modified Stare Excursion Balance test
- Timed up and Go test
- Exercise program includes:
- Lower extremity kinesthesia and balance exercise program
- Strength exercise program
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: G I primary KOA | Active comparator | Other: Balance exercise program, Other: Strengthening exercise programExercise and balance training |
| Group 2: G II primary KOA | Active comparator | Other: Balance exercise program, Other: Strengthening exercise programExercise and balance training |
| Group 3: G III primary KOA | Active comparator | Other: Balance exercise program, Other: Strengthening exercise programExercise and balance training |
| Group 4: G IV primary KOA | Active comparator | Other: Balance exercise program, Other: Strengthening exercise programExercise and balance training |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary knee osteoarthritis according to the EULAR recommendations 2010.
- Patients can complete at least stage 1 of balance and exercise program (minimum of 2 weeks)
Key exclusion criteria (5 listed)
- Patients that cannot complete at least stage 1 of balance and exercise program
- Patients with medical conditions affecting postural balance including visual, inner ear and neurological problems.
- Patients with lower limb joint or bony problems other than primary knee osteoarthritis .
- Patients with secondary KOA.
- Patients who received intra- articular joint injection in 1 or both knees in the past 90 days.
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 |
|---|---|---|
| Balance exercise programPatients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks. Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study. | Other | Group 1: G I primary KOA, Group 2: G II primary KOA, Group 3: G III primary KOA, Group 4: G IV primary KOA |
| Strengthening exercise programPatients will be engaged in strengthening exercise program 3 time per week for 6 weeks. Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study. | Other | Group 1: G I primary KOA, Group 2: G II primary KOA, Group 3: G III primary KOA, Group 4: G IV primary KOA |
Primary outcome
Assessment of pain
Time frame: 2-6 weeks
Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains pain sub-score and a overall total score. The higher the score the worst the pain.
Assessment of stiffness
Time frame: 2-6 weeks
Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains stiffness sub-score and a overall total score. The higher the score the worst the stiffness.
Assessment of physical function
Time frame: 2-6 weeks
Using the time up and go test, where the patient is seated and asked to get up walk a distance turn around and return to chair and sit again. It is measured using a timer, the longer the patient takes the worst the physical function of the patient.
1 secondary outcome
Dynamic Balance
Time frame: 2-6 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 26 May 2022.
- Individual participant dataSharing planned: No
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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.
Yousra H Abdel Fattah principal investigator
Alexandria University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance exercise program and Strengthening exercise program in people with Knee Osteoarthritis, run by University of Alexandria at 1 site in Egypt.
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 2 inclusion and 5 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 26 May 2022. 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 Egypt. 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?
Assessment of pain (time frame: 2-6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2022.