Knee OsteoarthritisNCT04496622
WBV Training on Physical Function and Muscle Strength in Knee OA
A study testing WBV technique and Whole body vibration technique in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
In this study compare different frequencies of whole body vibration training on physical function and muscle strength in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- WBV technique and Whole body vibration technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2019to 30 Jun 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-70 years
- Both genders
- Kellgren and Lawrance grade 2 and 3.
- Pain symptoms for at least 3 months
- Had no previous experience in WBV
Who cannot join
- Knee surgery in the past 6 months
- Patient with acute symptomatic knee OA
- Unable to walk unaided
- Diagnosed with other muscular and joint disease that affect the lower limb function
- Patient with any neurological conditions
- History of trauma to knee joint during last week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Frequencies of Whole Body Vibration Training on Physical Function and Muscle Strength in Patients With Knee Osteoarthritis
In this study compare different frequencies of whole body vibration training on physical function and muscle strength in patients with knee osteoarthritis.
Read the detailed description
This randomized controlled trial is to compare different frequencies of whole-body vibration (WBV) training on physical function and quadriceps muscle strength in patients with knee osteoarthritis and further will be researched which frequencies are effective for knee OA patients and how much WBV training is useful modality for knee osteoarthritic patients. This research will have significant effects in improving muscle strength and functional level of knee OA patients.
- Conditions
- Knee Osteoarthritis
- Being tested
- WBV technique, Whole body vibration technique
- Keywords
- Knee Osteoarthritis, Physical Function, Muscle Strength, Whole Body Vibration
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBV techniqueOther
Whole body vibration with frequency of 16-25 Hz were given from week 1-8 for 10 minutes/10 repetitions. Time were increased weekly Convention therapy were hot pack 10 minutes, stretching exercise (SLR) 10 repetition x 3 sets and quadriceps exercise 10 repetition x 3 sets.
3 session/week for 8 weeks
Whole body vibration techniqueOther
Whole body vibration with frequency of 26-35 Hz were given from week 1-8 for 10 minutes/10 repetitions. Time were increased weekly Convention therapy were hot pack 10 minutes, stretching exercise (SLR) 10 repetition x 3 sets and quadriceps exercise 10 repetition x 3 sets.
3 session/week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration Technique | Experimental | WBV training with the frequency of 16-25 Hz along with conventional treatment. Receives: Other: WBV technique |
| WBV Technique | Active comparator | WBV training with the frequency of 26-35 Hz along with conventional treatment. Receives: Other: Whole body vibration technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Changes from base line WOMAC is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of hip and knee. It consists of 3 sections with the total score of 96
Measured: 8 week
1 Repetition maximum (1 RM)
Changes from base line 1 RM measure muscle strength with maximum amount of weight that a person can possibly lift for one repetition
Measured: 8 week
Secondary outcomes (3)
Visual Analog Scale (VAS)
Changes from baseline visual analog scale for pain starting from 0-10
Measured: 8 week
Timed up and Go test (TUG)
Changes from baseline time up and go test to determine fall risk and measure the progress of balance, sit to stand and walking.
Measured: 8 week
6 minute walk test
Changes from baseline 6 minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Nov 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazish Rafique, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496622
- Sponsor's protocol ID
- REC/00235 Anam Pervez
- Status last verified
- Jul 2020
- First submitted
- 29 Jul 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suzuki Y, Iijima H, Tashiro Y, Kajiwara Y, Zeidan H, Shimoura K, Nishida Y, Bito T, Nakai K, Tatsumi M, Yoshimi S, Tsuboyama T, Aoyama T. Home exercise therapy to improve muscle strength and joint flexibility effectively treats pre-radiographic knee OA in community-dwelling elderly: a randomized controlled trial. Clin Rheumatol. 2019 Jan;38(1):133-141. doi: 10.1007/s10067-018-4263-3. Epub 2018 Aug 30.
PubMed 30167975Kus G, Yeldan I. Strengthening the quadriceps femoris muscle versus other knee training programs for the treatment of knee osteoarthritis. Rheumatol Int. 2019 Feb;39(2):203-218. doi: 10.1007/s00296-018-4199-6. Epub 2018 Nov 15.
PubMed 30430202Goh SL, Persson MSM, Stocks J, Hou Y, Welton NJ, Lin J, Hall MC, Doherty M, Zhang W. Relative Efficacy of Different Exercises for Pain, Function, Performance and Quality of Life in Knee and Hip Osteoarthritis: Systematic Review and Network Meta-Analysis. Sports Med. 2019 May;49(5):743-761. doi: 10.1007/s40279-019-01082-0.
PubMed 30830561Bacon KL, Segal NA, Oiestad BE, Lewis CE, Nevitt MC, Brown C, LaValley MP, McCulloch CE, Felson DT. Thresholds in the Relationship of Quadriceps Strength With Functional Limitations in Women With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2019 Sep;71(9):1186-1193. doi: 10.1002/acr.23740. Epub 2019 Aug 6.
PubMed 30156759Roddy E, Zhang W, Doherty M, Arden NK, Barlow J, Birrell F, Carr A, Chakravarty K, Dickson J, Hay E, Hosie G, Hurley M, Jordan KM, McCarthy C, McMurdo M, Mockett S, O'Reilly S, Peat G, Pendleton A, Richards S. Evidence-based recommendations for the role of exercise in the management of osteoarthritis of the hip or knee--the MOVE consensus. Rheumatology (Oxford). 2005 Jan;44(1):67-73. doi: 10.1093/rheumatology/keh399. Epub 2004 Sep 7.
PubMed 15353613Park SY, Son WM, Kwon OS. Effects of whole body vibration training on body composition, skeletal muscle strength, and cardiovascular health. J Exerc Rehabil. 2015 Dec 31;11(6):289-95. doi: 10.12965/jer.150254. eCollection 2015 Dec.
PubMed 26730378Gerodimos V, Zafeiridis A, Karatrantou K, Vasilopoulou T, Chanou K, Pispirikou E. The acute effects of different whole-body vibration amplitudes and frequencies on flexibility and vertical jumping performance. J Sci Med Sport. 2010 Jul;13(4):438-43. doi: 10.1016/j.jsams.2009.09.001. Epub 2009 Oct 22.
PubMed 19853506Lai Z, Wang X, Lee S, Hou X, Wang L. Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis: study protocol for a randomized controlled trial. Trials. 2017 Sep 20;18(1):437. doi: 10.1186/s13063-017-2170-6.
PubMed 28931439
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Frequencies of Whole Body Vibration Training on Physical Function and Muscle Strength in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04496622
- Acronym / sponsor ID
- REC/00235 Anam Pervez
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Physical Function, Muscle Strength, Whole Body Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 3 Aug 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.
In this study compare different frequencies of whole body vibration training on physical function and muscle strength in patients with knee osteoarthritis.
Detailed description
This randomized controlled trial is to compare different frequencies of whole-body vibration (WBV) training on physical function and quadriceps muscle strength in patients with knee osteoarthritis and further will be researched which frequencies are effective for knee OA patients and how much WBV training is useful modality for knee osteoarthritic patients. This research will have significant effects in improving muscle strength and functional level of knee OA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration Technique | Experimental | Other: WBV techniqueWBV training with the frequency of 16-25 Hz along with conventional treatment. |
| WBV Technique | Active comparator | Other: Whole body vibration techniqueWBV training with the frequency of 26-35 Hz along with conventional treatment. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40-70 years
- Both genders
- Kellgren and Lawrance grade 2 and 3.
- Pain symptoms for at least 3 months
- Had no previous experience in WBV
Key exclusion criteria (6 listed)
- Knee surgery in the past 6 months
- Patient with acute symptomatic knee OA
- Unable to walk unaided
- Diagnosed with other muscular and joint disease that affect the lower limb function
- Patient with any neurological 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 |
|---|---|---|
| WBV techniqueWhole body vibration with frequency of 16-25 Hz were given from week 1-8 for 10 minutes/10 repetitions. Time were increased weekly Convention therapy were hot pack 10 minutes, stretching exercise (SLR) 10 repetition x 3 sets and quadriceps exercise 10 repetition x 3 sets. 3 session/week for 8 weeks | Other | Whole Body Vibration Technique |
| Whole body vibration techniqueWhole body vibration with frequency of 26-35 Hz were given from week 1-8 for 10 minutes/10 repetitions. Time were increased weekly Convention therapy were hot pack 10 minutes, stretching exercise (SLR) 10 repetition x 3 sets and quadriceps exercise 10 repetition x 3 sets. 3 session/week for 8 weeks | Other | WBV Technique |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 8 week
Changes from base line WOMAC is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of hip and knee. It consists of 3 sections with the total score of 96
1 Repetition maximum (1 RM)
Time frame: 8 week
Changes from base line 1 RM measure muscle strength with maximum amount of weight that a person can possibly lift for one repetition
3 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 8 week
Timed up and Go test (TUG)
Time frame: 8 week
6 minute walk test
Time frame: 8 week
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 Aug 2020.
- Background: PubMed 30167975Suzuki Y, Iijima H, Tashiro Y, Kajiwara Y, Zeidan H, Shimoura K, Nishida Y, Bito T, Nakai K, Tatsumi M, Yoshimi S, Tsuboyama T, Aoyama T. Home exercise therapy to improve muscle strength and joint flexibility effectively treats pre-radiographic knee OA in community-dwelling elderly: a randomized controlled trial. Clin Rheumatol. 2019 Jan;38(1):133-141. doi: 10.1007/s10067-018-4263-3. Epub 2018 Aug 30.
- Background: PubMed 30430202Kus G, Yeldan I. Strengthening the quadriceps femoris muscle versus other knee training programs for the treatment of knee osteoarthritis. Rheumatol Int. 2019 Feb;39(2):203-218. doi: 10.1007/s00296-018-4199-6. Epub 2018 Nov 15.
- Background: PubMed 30830561Goh SL, Persson MSM, Stocks J, Hou Y, Welton NJ, Lin J, Hall MC, Doherty M, Zhang W. Relative Efficacy of Different Exercises for Pain, Function, Performance and Quality of Life in Knee and Hip Osteoarthritis: Systematic Review and Network Meta-Analysis. Sports Med. 2019 May;49(5):743-761. doi: 10.1007/s40279-019-01082-0.
- Background: PubMed 30156759Bacon KL, Segal NA, Oiestad BE, Lewis CE, Nevitt MC, Brown C, LaValley MP, McCulloch CE, Felson DT. Thresholds in the Relationship of Quadriceps Strength With Functional Limitations in Women With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2019 Sep;71(9):1186-1193. doi: 10.1002/acr.23740. Epub 2019 Aug 6.
- Background: PubMed 15353613Roddy E, Zhang W, Doherty M, Arden NK, Barlow J, Birrell F, Carr A, Chakravarty K, Dickson J, Hay E, Hosie G, Hurley M, Jordan KM, McCarthy C, McMurdo M, Mockett S, O'Reilly S, Peat G, Pendleton A, Richards S. Evidence-based recommendations for the role of exercise in the management of osteoarthritis of the hip or knee--the MOVE consensus. Rheumatology (Oxford). 2005 Jan;44(1):67-73. doi: 10.1093/rheumatology/keh399. Epub 2004 Sep 7.
- Background: PubMed 26730378Park SY, Son WM, Kwon OS. Effects of whole body vibration training on body composition, skeletal muscle strength, and cardiovascular health. J Exerc Rehabil. 2015 Dec 31;11(6):289-95. doi: 10.12965/jer.150254. eCollection 2015 Dec.
- Background: PubMed 19853506Gerodimos V, Zafeiridis A, Karatrantou K, Vasilopoulou T, Chanou K, Pispirikou E. The acute effects of different whole-body vibration amplitudes and frequencies on flexibility and vertical jumping performance. J Sci Med Sport. 2010 Jul;13(4):438-43. doi: 10.1016/j.jsams.2009.09.001. Epub 2009 Oct 22.
- Background: PubMed 28931439Lai Z, Wang X, Lee S, Hou X, Wang L. Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis: study protocol for a randomized controlled trial. Trials. 2017 Sep 20;18(1):437. doi: 10.1186/s13063-017-2170-6.
- 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.
Nazish Rafique, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WBV technique and Whole body vibration technique in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
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 6 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 Aug 2020. 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 Pakistan. 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?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 8 week). 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?
On the ClinicalTrials.gov record for NCT04496622, which also lists 8 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 Aug 2020.