Knee OsteoarthritisNCT06574334
Proprioceptive Exercises on Joint Pain and QoL Among Geriatric Patients With Knee Osteoarthritis
A study testing Proprioceptive exercise in people with Knee Osteoarthritis, run by Assiut University at 1 site in Egypt.
Trial summary
Knee osteoarthritis, the disease of knee joint pain caused by joint degeneration, it is the commonest joint disease and had a negative effect on geriatric patients' quality of life (QoL). Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Proprioceptive exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 31 May 2024
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Geriatric patients aged 60 years and above diagnosed with knee OA.
- Male and female geriatric patients.
- Alert and able to communicate.
- Mild and moderate knee OA (based on X-rays)
Who cannot join
- Patients with advanced knee OA.
- Patients with end stage organ failure.
- Patients with cognitive impairment who will not be able to take active part in the study.
- Patients with neurological impairment or physical disability that interfere with their participation in the study.
- Patients with uncontrolled medical conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Proprioceptive Exercises on Joint Pain and Quality of Life Among Geriatric Patients With Knee Osteoarthritis
Knee osteoarthritis, the disease of knee joint pain caused by joint degeneration, it is the commonest joint disease and had a negative effect on geriatric patients' quality of life (QoL). Proprioceptive exercise and isometric exercise have been recommended as suitable for reducing joint pain and improvement of quality of life in the geriatric patients.
Read the detailed description
Knee osteoarthritis (OA), known as degenerative joint disease of the knee. It is most common in the geriatric and is typically the result of wear and tear and progressive loss of articular cartilage. It happens when cartilage in knee joint breaks down. When this happens, the bones in knee joint rub together, causing friction that makes knees hurt, become stiff or swell. Knee OA is a painful condition and causes exhaustion in affected patients. Patients with this illness often complain of pain, decreased muscle strength, and joint instability. In addition, increased pain in knee OA patients also progressively worsen their quality-of-life. Proprioceptive activity in patients with knee OA gets limited or reduced and leads to reduced activities of daily living (ADLs). Joint proprioception is the ability of an individual to sense the joint position and movement. It encompasses the joint motion and joint position so proprioceptive exercises are being used for the strengthening of muscles around the knee joint. Thus, proprioceptive exercises are recommended exercise which significantly improved pain in knee OA patients which as results lead to improve quality of life. Quadriceps strengthening has been an important component of exercise program of knee osteoarthritis. This is because quadriceps weakness is the most presented finding among people with knee osteoarthritis. An isometric exercise is a form of exercise involving the static contraction of a muscle without any visible movement in the angle of the joint which lead to reduce joint pain and improving QoL in geriatric patients with knee osteoarthritis. The study sample (70) geriatric patients received proprioceptive exercises only, while the control group (70) geriatric patients received routine exercise (Isometric exercise) only.
- Conditions
- Knee Osteoarthritis
- Being tested
- Proprioceptive exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive exerciseProcedure or surgery
- The first session was included an orientation to the exercises and its purpose to geriatric participants in the first week. Also, pretest was done in the first session before implementing exercises to assess geriatric KOA pain and QOL, each session started by revision about what was given during the previous session and the objectives of the next session.
- The 2nd session about exercises.
- The 3rd session for repetition of exercises to ensure that the patient has learned it well in the second week.
- The 4th session after six weeks later (from wk. (3) to wk. (8) to make posttest after implementation session.
- The 5th session after two-month later (from wk. (9) to wk. (16) to do follow up test.
| Study group | Role | What they receive |
|---|---|---|
| The study group received proprioceptive exercises | Experimental | - The study group included education about definition, components and benefits of proprioceptive exercises for geriatric patients with knee osteoarthritis in the first week. Also, was including proprioceptive exercises that included; One-leg balance, Toe walking, Heel walking, Cross-body leg swings, Blind advanced one leg balance and instructed them to do these 5 exercises (15-20 repetitions of each) per session, 5 day a week. Receives: Procedure: Proprioceptive exercise |
| the control group received routine exercise (Isometric exercise). | Experimental | the control group included education about definition, benefits and steps of isometric exercise that included participants taking the long sitting position. A role of towel was placed below the affected knee. The participants were then asked to press the towel down and hold it to one minute and then relax. This was repeated again for the other knee and (10-15 repetitions) per session, 5 day a week. Receives: Procedure: Proprioceptive exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of proprioceptive exercises on joint pain among geriatric patients with knee osteoarthritis
By using Visual Analog Scales (VAS):
Measured: 3 months
Evaluate the effect of proprioceptive exercises on quality of life among geriatric patients with knee osteoarthritis
By using 36 - Item Short-Form Health Survey (SF-36).
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion31 May 2024
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- -Quasi experimental research design was used in this study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Hamdi Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574334
- Sponsor's protocol ID
- KOA Geriatric
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proprioceptive Exercises on Joint Pain and Quality of Life Among Geriatric Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06574334
- Acronym / sponsor ID
- KOA Geriatric
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 27 Aug 2024 (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.
Knee osteoarthritis, the disease of knee joint pain caused by joint degeneration, it is the commonest joint disease and had a negative effect on geriatric patients' quality of life (QoL). Proprioceptive exercise and isometric exercise have been recommended as suitable for reducing joint pain and improvement of quality of life in the geriatric patients.
Detailed description
Knee osteoarthritis (OA), known as degenerative joint disease of the knee. It is most common in the geriatric and is typically the result of wear and tear and progressive loss of articular cartilage. It happens when cartilage in knee joint breaks down. When this happens, the bones in knee joint rub together, causing friction that makes knees hurt, become stiff or swell. Knee OA is a painful condition and causes exhaustion in affected patients. Patients with this illness often complain of pain, decreased muscle strength, and joint instability. In addition, increased pain in knee OA patients also progressively worsen their quality-of-life. Proprioceptive activity in patients with knee OA gets limited or reduced and leads to reduced activities of daily living (ADLs). Joint proprioception is the ability of an individual to sense the joint position and movement. It encompasses the joint motion and joint position so proprioceptive exercises are being used for the strengthening of muscles around the knee joint. Thus, proprioceptive exercises are recommended exercise which significantly improved pain in knee OA patients which as results lead to improve quality of life. Quadriceps strengthening has been an important component of exercise program of knee osteoarthritis. This is because quadriceps weakness is the most presented finding among people with knee osteoarthritis. An isometric exercise is a form of exercise involving the static contraction of a muscle without any visible movement in the angle of the joint which lead to reduce joint pain and improving QoL in geriatric patients with knee osteoarthritis. The study sample (70) geriatric patients received proprioceptive exercises only, while the control group (70) geriatric patients received routine exercise (Isometric exercise) only.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- -Quasi experimental research design was used in this study
| Arm | Type | Receives |
|---|---|---|
| The study group received proprioceptive exercises | Experimental | Procedure: Proprioceptive exercise- The study group included education about definition, components and benefits of proprioceptive exercises for geriatric patients with knee osteoarthritis in the first week. Also, was including proprioceptive exercises that included; One-leg balance, Toe walking, Heel walking, Cross-body leg swings, Blind advanced one leg balance and instructed them to do these 5 exercises (15-20 repetitions of each) per session, 5 day a week. |
| the control group received routine exercise (Isometric exercise). | Experimental | Procedure: Proprioceptive exercisethe control group included education about definition, benefits and steps of isometric exercise that included participants taking the long sitting position. A role of towel was placed below the affected knee. The participants were then asked to press the towel down and hold it to one minute and then relax. This was repeated again for the other knee and (10-15 repetitions) per session, 5 day a week. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Geriatric patients aged 60 years and above diagnosed with knee OA.
- Male and female geriatric patients.
- Alert and able to communicate.
- Mild and moderate knee OA (based on X-rays)
Key exclusion criteria (5 listed)
- Patients with advanced knee OA.
- Patients with end stage organ failure.
- Patients with cognitive impairment who will not be able to take active part in the study.
- Patients with neurological impairment or physical disability that interfere with their participation in the study.
- Patients with uncontrolled medical conditions.
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 |
|---|---|---|
| Proprioceptive exercise* The first session was included an orientation to the exercises and its purpose to geriatric participants in the first week. Also, pretest was done in the first session before implementing exercises to assess geriatric KOA pain and QOL, each session started by revision about what was given during the previous session and the objectives of the next session. * The 2nd session about exercises. * The 3rd session for repetition of exercises to ensure that the patient has learned it well in the second week. * The 4th session after six weeks later (from wk. (3) to wk. (8) to make posttest after implementation session. * The 5th session after two-month later (from wk. (9) to wk. (16) to do follow up test. | Procedure or surgery | The study group received proprioceptive exercises, the control group received routine exercise (Isometric exercise). |
Primary outcome
Evaluate the effect of proprioceptive exercises on joint pain among geriatric patients with knee osteoarthritis
Time frame: 3 months
By using Visual Analog Scales (VAS):
Evaluate the effect of proprioceptive exercises on quality of life among geriatric patients with knee osteoarthritis
Time frame: 3months
By using 36 - Item Short-Form Health Survey (SF-36).
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 27 Aug 2024.
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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 Proprioceptive exercise in people with Knee Osteoarthritis, run by Assiut University 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 4 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 27 Aug 2024. 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?
Evaluate the effect of proprioceptive exercises on joint pain among geriatric patients with knee osteoarthritis (time frame: 3 months). The study lists 2 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 27 Aug 2024.