<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04496622</url>
  </required_header>
  <id_info>
    <org_study_id>REC/00235 Anam Pervez</org_study_id>
    <nct_id>NCT04496622</nct_id>
  </id_info>
  <brief_title>WBV Training on Physical Function and Muscle Strength in Knee OA</brief_title>
  <official_title>Comparison of Different Frequencies of Whole Body Vibration Training on Physical Function and Muscle Strength in Patients With Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riphah International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riphah International University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study compare different frequencies of whole body vibration training on physical&#xD;
      function and muscle strength in patients with knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized controlled trial is to compare different frequencies of whole-body vibration&#xD;
      (WBV) training on physical function and quadriceps muscle strength in patients with knee&#xD;
      osteoarthritis and further will be researched which frequencies are effective for knee OA&#xD;
      patients and how much WBV training is useful modality for knee osteoarthritic patients. This&#xD;
      research will have significant effects in improving muscle strength and functional level of&#xD;
      knee OA patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</measure>
    <time_frame>8 week</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>1 Repetition maximum (1 RM)</measure>
    <time_frame>8 week</time_frame>
    <description>Changes from base line 1 RM measure muscle strength with maximum amount of weight that a person can possibly lift for one repetition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>8 week</time_frame>
    <description>Changes from baseline visual analog scale for pain starting from 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and Go test (TUG)</measure>
    <time_frame>8 week</time_frame>
    <description>Changes from baseline time up and go test to determine fall risk and measure the progress of balance, sit to stand and walking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 minute walk test</measure>
    <time_frame>8 week</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Whole Body Vibration Technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>WBV training with the frequency of 16-25 Hz along with conventional treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WBV Technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>WBV training with the frequency of 26-35 Hz along with conventional treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WBV technique</intervention_name>
    <description>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.&#xD;
3 session/week for 8 weeks</description>
    <arm_group_label>Whole Body Vibration Technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole body vibration technique</intervention_name>
    <description>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.&#xD;
3 session/week for 8 weeks</description>
    <arm_group_label>WBV Technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 40-70 years&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Kellgren and Lawrance grade 2 and 3.&#xD;
&#xD;
          -  Pain symptoms for at least 3 months&#xD;
&#xD;
          -  Had no previous experience in WBV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Knee surgery in the past 6 months&#xD;
&#xD;
          -  Patient with acute symptomatic knee OA&#xD;
&#xD;
          -  Unable to walk unaided&#xD;
&#xD;
          -  Diagnosed with other muscular and joint disease that affect the lower limb function&#xD;
&#xD;
          -  Patient with any neurological conditions&#xD;
&#xD;
          -  History of trauma to knee joint during last week.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nazish Rafique, MSPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Riphah International University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Railway General Hospital</name>
      <address>
        <city>Rawalpindi</city>
        <state>Punjab</state>
        <zip>44000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>30167975</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30430202</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30830561</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30156759</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15353613</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26730378</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19853506</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28931439</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee Osteoarthritis</keyword>
  <keyword>Physical Function</keyword>
  <keyword>Muscle Strength</keyword>
  <keyword>Whole Body Vibration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04496622
org study id: REC/00235 Anam Pervez
nct id: NCT04496622
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study compare different frequencies of whole body vibration training on physical
      function and muscle strength in patients with knee osteoarthritis.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
time frame: 8 week
description: 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
measure: 1 Repetition maximum (1 RM)
time frame: 8 week
description: Changes from base line 1 RM measure muscle strength with maximum amount of weight that a person can possibly lift for one repetition
measure: Visual Analog Scale (VAS)
time frame: 8 week
description: Changes from baseline visual analog scale for pain starting from 0-10
measure: Timed up and Go test (TUG)
time frame: 8 week
description: Changes from baseline time up and go test to determine fall risk and measure the progress of balance, sit to stand and walking.
measure: 6 minute walk test
time frame: 8 week
description: 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
arm group label: Whole Body Vibration Technique
arm group type: Experimental
description: WBV training with the frequency of 16-25 Hz along with conventional treatment.
arm group label: WBV Technique
arm group type: Active Comparator
description: WBV training with the frequency of 26-35 Hz along with conventional treatment.
intervention type: Other
intervention name: WBV technique
description: 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
arm group label: Whole Body Vibration Technique
intervention type: Other
intervention name: Whole body vibration technique
description: 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
arm group label: WBV Technique
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nazish Rafique, MSPT
role: Principal Investigator
affiliation: Riphah International University
facility: 
country: Pakistan
citation: 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.
PMID: 30167975
citation: 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.
PMID: 30430202
citation: 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.
PMID: 30830561
citation: 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.
PMID: 30156759
citation: 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.
PMID: 15353613
citation: 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.
PMID: 26730378
citation: 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.
PMID: 19853506
citation: 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.
PMID: 28931439
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No