Knee OANCT06711341
Comparing Exercise Programs for Managing Knee Osteoarthritis
A study testing Whole-body Vibration (WBV) Training, Progressive Resistance Exercise (PRE) and Home-Based Exercise in people with Knee OA and Osteoarthritis, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to assess and compare the effectiveness of three different exercise modalities-whole-body vibration exercise, progressive resistance exercise, and home-based exercise -in improving quadriceps isometric muscle strength, physical function, balance, knee pain, osteoarthritis symptoms… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Knee OA, Osteoarthritis, Osteoarthritis (OA) of the Knee
- What is being tested?
- Whole-body Vibration (WBV) Training, Progressive Resistance Exercise (PRE) and Home-Based Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Aug 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants between the ages of 45-70,
- diagnosed with knee osteoarthritis according to ACR criteria (unilateral or bilateral),
- having grade 2 or 3 tibiofemoral knee osteoarthritis according to Kellgren-Lawrence staging,
- having knee pain due to OA for a minimum of 3 months prior to enrollment,
- patients whose medical treatment is not expected to change during the study period.
Who cannot join
- having or had undergone knee surgery,
- patients unable to walk without support,
- having musculoskeletal limitations that prevent participation in resistance exercises (contracture, fracture, etc.),
- other neurological, cardiac, respiratory and systemic diseases that will affect physical activity,
- currently implementing a regular exercise or physical therapy program specific to knee OA
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uludağ University Hospital Physical Medicine and Rehabilitation Clinic
Bursa, Nilüfer, 16059
About this study
Official title: Investigating The Most Effective Exercise Modality in Knee Osteoarthritis; A RCT
The goal of this clinical trial is to assess and compare the effectiveness of three different exercise modalities-whole-body vibration exercise, progressive resistance exercise, and home-based exercise -in improving quadriceps isometric muscle strength, physical function, balance, knee pain, osteoarthritis symptoms, and overall quality of life in individuals with knee osteoarthritis.
The main questions it aims to answer are:
Read more
- How do WBV, PRE, and home-based exercise compare in improving quadriceps strength in people with knee osteoarthritis?
- Which exercise modality leads to the greatest improvements in physical function, balance, knee pain, and quality of life?
Researchers will compare the three exercise regimens to determine which is most effective for improving knee function and relieving osteoarthritis symptoms.
Participants will:
- Engage in whole-body vibration exercise, progressive resistance exercise, or home-based exercise for 3 weeks.
- Undergo assessments before and at the end of the exercise program, including tests for physical function and balance (Timed Up and Go Test, 5x Sit to Stand Test) and questionnaires to evaluate knee osteoarthritis symptoms (WOMAC), quality of life (SF-36), and self-reported knee pain (Numeric Rating Scale).
- Conditions
- Knee OA, Osteoarthritis, Osteoarthritis (OA) of the Knee
- Being tested
- Whole-body Vibration (WBV) Training, Progressive Resistance Exercise (PRE), Home-Based Exercise
- Keywords
- Exercise, Knee Osteoarthritis, Pain, Strength, Whole-Body Vibration
- Medical subject headings
- Osteoarthritis, Motor Activity, Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body Vibration (WBV) TrainingDevice
Also called WBV
Participants use the "Compex Winplate," designed specifically for vibration training. The device is set with a frequency of 30 Hz and an amplitude of 4 mm. Participants perform a total of 5 exercises consisting of static and dynamic squat exercises, with a 30-second rest period between sets and between different exercises. The exercises and progression over the weeks are as follows:
Week 1:
- Static squat with knees flexed at 30° - 2 sets of 30 seconds each
- Dynamic squat with knees flexed between 0-60° - 2 sets of 30 seconds each
- Fingertip-to-sole partial dynamic squat with knees flexed at 30° - 2 sets of 30 seconds each
- Consecutive weight transfer with knees flexed at 45° - 2 sets of 30 seconds each
- Single leg static squat with knees flexed at 30° - 30 seconds per leg
Subsequent Weeks: The duration of each set increases by 10 seconds each week. Each training session includes a 5-minute warm-up and a 5-minute cooldown, consisting of joint motion and muscle stretching exercises.
Progressive Resistance Exercise (PRE)Behavioural
Also called PRE
Training Duration: Participants undergo approximately 15-20 minute training sessions, 3 days per week for 3 weeks.
Exercise Regimen: The training focuses on strengthening the quadriceps muscles using ankle weights. The load is determined using the DeLorme principle:
- At the beginning of each week, the 10-repetition maximum (10RM) is measured.
- During that week, participants perform their training sets as follows:
- First set: 50% of 10RM
- Second set: 75% of 10RM
- Final set: 100% of 10RM Each training session includes a 5-minute warm-up and a 5-minute cooldown, consisting of joint motion and muscle stretching exercises.
Home-Based ExerciseBehavioural
Protocol: Participants receive a printed document with instructions for home exercises and are instructed on how to perform the exercises.
Training Duration: Sessions are conducted three days per week for 3 weeks.
Exercise Regimen: The exercises include:
- Bilateral Quadriceps Isometric Exercise: Participants lie on their backs with a roll below each knee, pressing for 10-second holds, totaling 20 repetitions.
- Knee Extensions: Participants performed knee extensions while seated, holding each extension for 5 seconds, completing 10 repetitions per leg.
- Knee Range of Motion (ROM) Exercises: Participants lie face down and alternately bend their knees, completing 10 repetitions.
Each training session includes a 5-minute warm-up and a 5-minute cooldown, consisting of joint motion and muscle stretching exercises
| Study group | Role | What they receive |
|---|---|---|
| Whole-body Vibration (WBV) Training Group | Active comparator | Participants undergo WBV training as outlined in the WBV intervention, 3 days per week for 3 weeks. The sessions begin with a duration of 10 minutes in the first week, with the duration increasing each week thereafter. They also perform the home exercises assigned to the Control group on the same days as their PRE sessions. Receives: Device: Whole-body Vibration (WBV) Training |
| Progressive Resistance Exercise (PRE) Group | Active comparator | Participants undergo PRE training as outlined in the PRE intervention, 3 days per week for 3 weeks. The training focuses on strengthening the quadriceps muscles using ankle weights. The load is determined using the DeLorme principle at the start of each week. They also perform the home exercises assigned to the Control group on the same days as their PRE sessions. Receives: Behavioral: Progressive Resistance Exercise (PRE) |
| Control Group (Home-Based Exercise) | Active comparator | Participants perform home exercises three days per week for 3 weeks. The exercises consist of range of motion (ROM) and isometric strengthening exercises as detailed in the intervention section. Receives: Behavioral: Home-Based Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Isometric Muscle Strength
Quadriceps isometric muscle strength is measured using an Isokinetic dynamometer (CSMI Humac Norm, Stoughton, MA). Measurements are taken in a sitting position with the knee positioned at two angles: 30° and 60° of flexion. For each angle, one trial is performed followed by three real measurements, with the highest peak torque recorded in Newton-meters (Nm). Participants are secured to the dynamometer, and all settings and positions are standardized. Prior to measurements, the device is calibrated, and participants perform a 5-minute warm-up and familiarize themselves with the test procedure. Verbal encouragement is provided during the tests.
Measured: at baseline and 3-weeks
Secondary outcomes (5)
Timed Up and Go (TUG) Test (Physical Function and Balance)
The TUG test assesses lower-extremity function performance, dynamic balance, and fall risk. Participants stand up from a standard chair (43 cm height), walk 3 meters, turn around, walk back to the chair, and sit down. Timing is performed using a chronograph, and one practice trial is conducted before the actual test. The entire walking test is timed in seconds.
Measured: at baseline and 3-weeks
Five Times Sit to Stand Test (5xSST) (Physical Function and Balance)
Five Times Sit to Stand Test (5xSST): The 5xSST evaluates functional lower limb strength, transitional movements, balance, and fall risk. Participants sit on a chair with their back supported, fold their arms across their chest, and then sit and stand five times as quickly as possible without resting their back or legs on the chair. Timing is performed using a chronograph.
Measured: at baseline and 3-weeks
Numeric Rating Scale (NRS) (Self-reported Knee Pain)
Self-reported knee pain is assessed using a 10-cm numeric scale, where 0 indicates no pain and 10 represents maximal pain. Participants rate their most severe pain level experienced over the past week, both at rest and during activity.
Measured: at baseline and 3-weeks
WOMAC (Knee Osteoarthritis Symptoms and Function)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) evaluates symptoms and functional status through 24 questions, rated from 0 (best) to 4 (worst). The index includes five questions on knee pain severity, two questions on stiffness, and 17 questions on physical function limitations.
Measured: at baseline and 3-weeks
SF-36 (Quality of Life)
The Medical Outcomes Short Form 36 (SF-36) assesses health-related quality of life through 36 items rated on Likert scales. Various sub-scores reflect different aspects of health-related quality of life, with higher scores indicating better outcomes.
Measured: at baseline and 3-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Aug 2023
- Primary completion1 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OAStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Alabdallah Alalewy, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711341
- Sponsor's protocol ID
- 2023-15/19
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made available due to privacy concerns and the fact that the data collected are not intended for sharing outside of the scope of the study's analysis. Additionally, there are no plans for secondary research involving the data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating The Most Effective Exercise Modality in Knee Osteoarthritis; A RCT
- ClinicalTrials.gov ID
- NCT06711341
- Acronym / sponsor ID
- 2023-15/19
- Conditions
- Knee OA, Osteoarthritis, Osteoarthritis (OA) of the Knee
- Keywords
- Exercise, Knee Osteoarthritis, Pain, Strength, Whole-Body Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 2 Dec 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.
The goal of this clinical trial is to assess and compare the effectiveness of three different exercise modalities-whole-body vibration exercise, progressive resistance exercise, and home-based exercise -in improving quadriceps isometric muscle strength, physical function, balance, knee pain, osteoarthritis symptoms, and overall quality of life in individuals with knee osteoarthritis.
The main questions it aims to answer are:
- How do WBV, PRE, and home-based exercise compare in improving quadriceps strength in people with knee osteoarthritis?
- Which exercise modality leads to the greatest improvements in physical function, balance, knee pain, and quality of life?
Researchers will compare the three exercise regimens to determine which is most effective for improving knee function and relieving osteoarthritis symptoms.
Participants will:
- Engage in whole-body vibration exercise, progressive resistance exercise, or home-based exercise for 3 weeks.
- Undergo assessments before and at the end of the exercise program, including tests for physical function and balance (Timed Up and Go Test, 5x Sit to Stand Test) and questionnaires to evaluate knee osteoarthritis symptoms (WOMAC), quality of life (SF-36), and self-reported knee pain (Numeric Rating Scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole-body Vibration (WBV) Training Group | Active comparator | Device: Whole-body Vibration (WBV) TrainingParticipants undergo WBV training as outlined in the WBV intervention, 3 days per week for 3 weeks. The sessions begin with a duration of 10 minutes in the first week, with the duration increasing each week thereafter. They also perform the home exercises assigned to the Control group on the same days as their PRE sessions. |
| Progressive Resistance Exercise (PRE) Group | Active comparator | Behavioral: Progressive Resistance Exercise (PRE)Participants undergo PRE training as outlined in the PRE intervention, 3 days per week for 3 weeks. The training focuses on strengthening the quadriceps muscles using ankle weights. The load is determined using the DeLorme principle at the start of each week. They also perform the home exercises assigned to the Control group on the same days as their PRE sessions. |
| Control Group (Home-Based Exercise) | Active comparator | Behavioral: Home-Based ExerciseParticipants perform home exercises three days per week for 3 weeks. The exercises consist of range of motion (ROM) and isometric strengthening exercises as detailed in the intervention section. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- participants between the ages of 45-70,
- diagnosed with knee osteoarthritis according to ACR criteria (unilateral or bilateral),
- having grade 2 or 3 tibiofemoral knee osteoarthritis according to Kellgren-Lawrence staging,
- having knee pain due to OA for a minimum of 3 months prior to enrollment,
- patients whose medical treatment is not expected to change during the study period.
Key exclusion criteria (5 listed)
- having or had undergone knee surgery,
- patients unable to walk without support,
- having musculoskeletal limitations that prevent participation in resistance exercises (contracture, fracture, etc.),
- other neurological, cardiac, respiratory and systemic diseases that will affect physical activity,
- currently implementing a regular exercise or physical therapy program specific to knee OA
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 |
|---|---|---|
| Whole-body Vibration (WBV) TrainingAlso: WBVParticipants use the "Compex Winplate," designed specifically for vibration training. The device is set with a frequency of 30 Hz and an amplitude of 4 mm. Participants perform a total of 5 exercises consisting of static and dynamic squat exercises, with a 30-second rest period between sets and between different exercises. The exercises and progression over the weeks are as follows: Week 1: * Static squat with knees flexed at 30° - 2 sets of 30 seconds each * Dynamic squat with knees flexed between 0-60° - 2 sets of 30 seconds each * Fingertip-to-sole partial dynamic squat with knees flexed at 30° - 2 sets of 30 seconds each * Consecutive weight transfer with knees flexed at 45° - 2 sets of 30 seconds each * Single leg static squat with knees flexed at 30° - 30 seconds per leg Subsequent Weeks: The duration of each set increases by 10 seconds each week. Each training session includes a 5-minute warm-up and a 5-minute cooldown, consisting of joint motion and muscle stretching exercises. | Device | Whole-body Vibration (WBV) Training Group |
| Progressive Resistance Exercise (PRE)Also: PRETraining Duration: Participants undergo approximately 15-20 minute training sessions, 3 days per week for 3 weeks. Exercise Regimen: The training focuses on strengthening the quadriceps muscles using ankle weights. The load is determined using the DeLorme principle: * At the beginning of each week, the 10-repetition maximum (10RM) is measured. * During that week, participants perform their training sets as follows: * First set: 50% of 10RM * Second set: 75% of 10RM * Final set: 100% of 10RM Each training session includes a 5-minute warm-up and a 5-minute cooldown, consisting of joint motion and muscle stretching exercises. | Behavioural | Progressive Resistance Exercise (PRE) Group |
| Home-Based ExerciseProtocol: Participants receive a printed document with instructions for home exercises and are instructed on how to perform the exercises. Training Duration: Sessions are conducted three days per week for 3 weeks. Exercise Regimen: The exercises include: * Bilateral Quadriceps Isometric Exercise: Participants lie on their backs with a roll below each knee, pressing for 10-second holds, totaling 20 repetitions. * Knee Extensions: Participants performed knee extensions while seated, holding each extension for 5 seconds, completing 10 repetitions per leg. * Knee Range of Motion (ROM) Exercises: Participants lie face down and alternately bend their knees, completing 10 repetitions. Each training session includes a 5-minute warm-up and a 5-minute cooldown, consisting of joint motion and muscle stretching exercises | Behavioural | Control Group (Home-Based Exercise) |
Primary outcome
Quadriceps Isometric Muscle Strength
Time frame: at baseline and 3-weeks
Quadriceps isometric muscle strength is measured using an Isokinetic dynamometer (CSMI Humac Norm, Stoughton, MA). Measurements are taken in a sitting position with the knee positioned at two angles: 30° and 60° of flexion. For each angle, one trial is performed followed by three real measurements, with the highest peak torque recorded in Newton-meters (Nm). Participants are secured to the dynamometer, and all settings and positions are standardized. Prior to measurements, the device is calibrated, and participants perform a 5-minute warm-up and familiarize themselves with the test procedure. Verbal encouragement is provided during the tests.
5 secondary outcomes
Timed Up and Go (TUG) Test (Physical Function and Balance)
Time frame: at baseline and 3-weeks
Five Times Sit to Stand Test (5xSST) (Physical Function and Balance)
Time frame: at baseline and 3-weeks
Numeric Rating Scale (NRS) (Self-reported Knee Pain)
Time frame: at baseline and 3-weeks
WOMAC (Knee Osteoarthritis Symptoms and Function)
Time frame: at baseline and 3-weeks
SF-36 (Quality of Life)
Time frame: at baseline and 3-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 2 Dec 2024.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made available due to privacy concerns and the fact that the data collected are not intended for sharing outside of the scope of the study's analysis. Additionally, there are no plans for secondary research involving the data.
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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 Whole-body Vibration (WBV) Training, Progressive Resistance Exercise (PRE) and Home-Based Exercise in people with Knee OA and Osteoarthritis, run by Uludag University at 1 site in Turkey (Türkiye).
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 5 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 2 Dec 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 Turkey (Türkiye). 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?
Quadriceps Isometric Muscle Strength (time frame: at baseline and 3-weeks). 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 2 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.