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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Pakistan1 site
  • Railway General Hospital

    Rawalpindi, Punjab Province, 44000

Other trials in Pakistan

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.

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 groups in NCT04496622
Study groupRoleWhat they receive
Whole Body Vibration TechniqueExperimentalWBV training with the frequency of 16-25 Hz along with conventional treatment.
Receives: Other: WBV technique
WBV TechniqueActive comparatorWBV 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.

  1. 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

  2. 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)
  1. Visual Analog Scale (VAS)

    Changes from baseline visual analog scale for pain starting from 0-10

    Measured: 8 week

  2. 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

  3. 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.

  1. First posted3 Aug 2020
  2. Study start1 Nov 2019
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

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)
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 30167975
  • Kus 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 30430202
  • Goh 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 30830561
  • Bacon 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 30156759
  • Roddy 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 15353613
  • Park 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 26730378
  • Gerodimos 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 19853506
  • Lai 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

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.

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