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WBV Training on Physical Function and Muscle Strength in Knee OA

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
WBV technique
Whole body vibration technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Physical Function, Muscle Strength, Whole Body Vibration

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Railway General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Whole Body Vibration Technique

WBV Technique

Arm Description

WBV training with the frequency of 16-25 Hz along with conventional treatment.

WBV training with the frequency of 26-35 Hz along with conventional treatment.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Visual Analog Scale (VAS)
Changes from baseline visual analog scale for pain starting from 0-10
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.
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

Full Information

First Posted
July 29, 2020
Last Updated
July 31, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04496622
Brief Title
WBV Training on Physical Function and Muscle Strength in Knee OA
Official Title
Comparison of Different Frequencies of Whole Body Vibration Training on Physical Function and Muscle Strength in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, Physical Function, Muscle Strength, Whole Body Vibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole Body Vibration Technique
Arm Type
Experimental
Arm Description
WBV training with the frequency of 16-25 Hz along with conventional treatment.
Arm Title
WBV Technique
Arm Type
Active Comparator
Arm Description
WBV training with the frequency of 26-35 Hz along with conventional treatment.
Intervention Type
Other
Intervention Name(s)
WBV technique
Intervention 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
Intervention Type
Other
Intervention Name(s)
Whole body vibration technique
Intervention 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
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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
Time Frame
8 week
Title
1 Repetition maximum (1 RM)
Description
Changes from base line 1 RM measure muscle strength with maximum amount of weight that a person can possibly lift for one repetition
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
Changes from baseline visual analog scale for pain starting from 0-10
Time Frame
8 week
Title
Timed up and Go test (TUG)
Description
Changes from baseline time up and go test to determine fall risk and measure the progress of balance, sit to stand and walking.
Time Frame
8 week
Title
6 minute walk test
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
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazish Rafique, MSPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Railway General Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30167975
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.
Results Reference
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PubMed Identifier
30430202
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.
Results Reference
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PubMed Identifier
30830561
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.
Results Reference
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PubMed Identifier
30156759
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.
Results Reference
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PubMed Identifier
15353613
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.
Results Reference
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PubMed Identifier
26730378
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.
Results Reference
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PubMed Identifier
19853506
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.
Results Reference
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PubMed Identifier
28931439
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.
Results Reference
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WBV Training on Physical Function and Muscle Strength in Knee OA

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