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Investigating the Effectiveness of Vibration Therapy on Sarcopenia in Osteoarthritis Knee Patients

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ClinicalTrials.gov Identifier: NCT03880344
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Ho Ki Wai, Chinese University of Hong Kong

Brief Summary:
Osteoarthritis (OA) is one of the commonest chronic degenerative conditions affecting our aging population. It limits joint movement and causing disability in elderlies due to discordant symptoms such as pain and stiffness. The prevalence of radiologic knee osteoarthritis increases in proportion to age, reaching an astounding 64.1% for patients whom are over 60 years of age. In addition the prevalence of symptomatic knee OA has been shown to be around 10% in people who are 60 years and older.

Condition or disease Intervention/treatment Phase
Knee Arthropathy Osteoarthritis, Knee Knee Osteoarthritis Device: Vibration Therapy Combination Product: Physiotherapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Control Trial Investigating the Effectiveness of Vibration Therapy on Sarcopenia in Osteoarthritis Knee Patients
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Vibration Therapy + Normal Out-Patient Physiotherapy
Patients' randomized to this group will receive vibration therapy as a pre-operative rehabilitation programme 3 times a week for 3 months. Regular out-patient department physiotherapy will also be given. They will be assessed 6 weeks and 6 months post operatively.
Device: Vibration Therapy
Vibration therapy as a pre-operative rehabilitation programme 3 times a week for 3 months + Normal Regular out-patient department physiotherapy

Combination Product: Physiotherapy
Physiotherapy as post-operative rehabilitation programme for 6 months.

Active Comparator: Normal Out-Patient Department Physiotherapy
Patients randomized to this group will receive regular out-patient department physiotherapy postoperatively for 6 months. They will be assessed 6 weeks and 6 months post operatively.
Combination Product: Physiotherapy
Physiotherapy as post-operative rehabilitation programme for 6 months.




Primary Outcome Measures :
  1. Knee Flexion/Extension Strength [ Time Frame: Baseline Assessment ]
    Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.

  2. Knee Flexion/Extension Strength [ Time Frame: Pre-Operative Assessment ]
    Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.

  3. Knee Flexion/Extension Strength [ Time Frame: Post-Operative 6 weeks ]
    Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.

  4. Knee Flexion/Extension Strength [ Time Frame: Post-Operative 6 months ]
    Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.

  5. Knee Flexion/Extension Strength [ Time Frame: Post-Operative 12 months ]
    Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.


Secondary Outcome Measures :
  1. Whole body lean muscle mass [ Time Frame: Baseline Assessment ]
    DXA measurement scan

  2. Whole body lean muscle mass [ Time Frame: Pre-Operative Assessment ]
    DXA measurement scan

  3. Whole body lean muscle mass [ Time Frame: Post-Operative 6 months ]
    DXA measurement scan

  4. Muscle Biopsy [ Time Frame: Intra-Operatively ]
    Types of muscle fibers and satellite cells as Assessed by Muscle Biopsy Assessment

  5. Knee Functions measure by the Knee Society Score [ Time Frame: Baseline Assessment ]
    Physician will assess on the Visual Analog Scale in pain score (None to Severe), Flexion Contracture (None to >20°), Extension lag (None to 20°), Total Range of Flexion (0-5° to 121-125°), Alignment (0° to Over 15°), Antero-posterior stability (<5mm to 10+mm), Mediolateral stability (<5° to 15°). Patients will record individuals' satisfaction, functional activities, and expectations.

  6. Knee Functions measure by the Knee Society Score [ Time Frame: Pre-Operative Assessment ]
    Physician will assess on the Visual Analog Scale in pain score (None to Severe), Flexion Contracture (None to >20°), Extension lag (None to 20°), Total Range of Flexion (0-5° to 121-125°), Alignment (0° to Over 15°), Antero-posterior stability (<5mm to 10+mm), Mediolateral stability (<5° to 15°). Patients will record individuals' satisfaction, functional activities, and expectations.

  7. Knee Functions measure by the Knee Society Score [ Time Frame: Post-Operative 6 weeks ]
    Physician will assess on the Visual Analog Scale in pain score (None to Severe), Flexion Contracture (None to >20°), Extension lag (None to 20°), Total Range of Flexion (0-5° to 121-125°), Alignment (0° to Over 15°), Antero-posterior stability (<5mm to 10+mm), Mediolateral stability (<5° to 15°). Patients will record individuals' satisfaction, functional activities, and expectations.

  8. Knee Functions measure by the Knee Society Score [ Time Frame: Post-Operative 6 months ]
    Physician will assess on the Visual Analog Scale in pain score (None to Severe), Flexion Contracture (None to >20°), Extension lag (None to 20°), Total Range of Flexion (0-5° to 121-125°), Alignment (0° to Over 15°), Antero-posterior stability (<5mm to 10+mm), Mediolateral stability (<5° to 15°). Patients will record individuals' satisfaction, functional activities, and expectations.

  9. Knee Functions measure by the Knee Society Score [ Time Frame: Post-Operative 12 months ]
    Physician will assess on the Visual Analog Scale in pain score (None to Severe), Flexion Contracture (None to >20°), Extension lag (None to 20°), Total Range of Flexion (0-5° to 121-125°), Alignment (0° to Over 15°), Antero-posterior stability (<5mm to 10+mm), Mediolateral stability (<5° to 15°). Patients will record individuals' satisfaction, functional activities, and expectations.

  10. Knee Function measures by 6 meter Timed Walking Gait Test [ Time Frame: Baseline Assessment ]
    The 10 meter timed walking test is a well-established and documented test for assessment for gait speed in patients. However, due to space limitations and the exhaustive nature of the test for patients with OA, the 6 meter test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (<7.5 seconds is normal).

  11. Knee Function measures by 6 meter Timed Walking Gait Test [ Time Frame: Pre-Operative Assessment ]
    The 10 meter timed walking test is a well-established and documented test for assessment for gait speed in patients. However, due to space limitations and the exhaustive nature of the test for patients with OA, the 6 meter test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (<7.5 seconds is normal).

  12. Knee Function measures by 6 meter Timed Walking Gait Test [ Time Frame: Post-Operative 6 weeks ]
    The 10 meter timed walking test is a well-established and documented test for assessment for gait speed in patients. However, due to space limitations and the exhaustive nature of the test for patients with OA, the 6 meter test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (<7.5 seconds is normal).

  13. Knee Function measures by 6 meter Timed Walking Gait Test [ Time Frame: Post-Operative 6 months ]
    The 10 meter timed walking test is a well-established and documented test for assessment for gait speed in patients. However, due to space limitations and the exhaustive nature of the test for patients with OA, the 6 meter test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (<7.5 seconds is normal).

  14. SF-12 [ Time Frame: Baseline Assessment ]
    The 36-Item Short Form Health Survey (SF-12) will be used to measure the health related Quality of Life. The SF-12 has twelve questions ; the scores are weighted sums of the questions in each section. Scores range from 0 - 60. Lower scores = more disability, higher scores = less disability.

  15. SF-12 [ Time Frame: Pre-Operative Assessment ]
    The 36-Item Short Form Health Survey (SF-12) will be used to measure the health related Quality of Life. The SF-12 has twelve questions ; the scores are weighted sums of the questions in each section. Scores range from 0 - 60. Lower scores = more disability, higher scores = less disability.

  16. SF-12 [ Time Frame: Post-Operative 6 weeks ]
    The 36-Item Short Form Health Survey (SF-12) will be used to measure the health related Quality of Life. The SF-12 has twelve questions ; the scores are weighted sums of the questions in each section. Scores range from 0 - 60. Lower scores = more disability, higher scores = less disability.

  17. SF-12 [ Time Frame: Post-Operative 6 months ]
    The 36-Item Short Form Health Survey (SF-12) will be used to measure the health related Quality of Life. The SF-12 has twelve questions ; the scores are weighted sums of the questions in each section. Scores range from 0 - 60. Lower scores = more disability, higher scores = less disability.

  18. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: Baseline Assessment ]
    The WOMAC will be used as a self-administered health status measure in assessing pain, stiffness, and function in patients with OA of the hip or knee. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  19. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: Pre-Operative Assessment ]
    The WOMAC will be used as a self-administered health status measure in assessing pain, stiffness, and function in patients with OA of the hip or knee. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  20. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: Post-Operative 6 weeks ]
    The WOMAC will be used as a self-administered health status measure in assessing pain, stiffness, and function in patients with OA of the hip or knee. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. With a scale ranges from 0 to 96. Lower scores = more disability, higher scores = less disability.

  21. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: Post-Operative 6 months ]
    The WOMAC will be used as a self-administered health status measure in assessing pain, stiffness, and function in patients with OA of the hip or knee. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. With a scale ranges from 0 to 96. Lower scores = more disability, higher scores = less disability.

  22. IPAQ [ Time Frame: Baseline Assessment ]
    The 36-Item Short Form Health Survey (SF-12) will be used to measure health-related physical activity (PA) performance. With a scale ranges from 0 to 96. Lower scores = more disability, higher scores = less disability.

  23. IPAQ [ Time Frame: Pre-Operative Assessment ]
    The 36-Item Short Form Health Survey (SF-12) will be used to measure health-related physical activity (PA) performance. Score is expressed as MET-min per week: MET level x minutes of activity x events per week. Computed to fall into the category of: "Low", "Moderate" and "High" level of Physical Activity.

  24. IPAQ [ Time Frame: Post-Operative 6 weeks ]
    The 36-Item Short Form Health Survey (SF-12) will be used to measure health-related physical activity (PA) performance. Score is expressed as MET-min per week: MET level x minutes of activity x events per week. Computed to fall into the category of: "Low", "Moderate" and "High" level of Physical Activity.

  25. IPAQ [ Time Frame: Post-Operative 6 months ]
    The 36-Item Short Form Health Survey (SF-12) will be used to measure health-related physical activity (PA) performance. Score is expressed as MET-min per week: MET level x minutes of activity x events per week. Computed to fall into the category of: "Low", "Moderate" and "High" level of Physical Activity.

  26. Hand-grip Strength [ Time Frame: Baseline Assessment ]
    Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.

  27. Hand-grip Strength [ Time Frame: Pre-Operative Assessment ]
    Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.

  28. Hand-grip Strength [ Time Frame: Post-Operative 6 weeks ]
    Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.

  29. Hand-grip Strength [ Time Frame: Post-Operative 6 months ]
    Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.

  30. Gait Speed [ Time Frame: Baseline Assessment ]
    6 meter timed walking gait test

  31. Gait Speed [ Time Frame: Pre-Operative Assessment ]
    6 meter timed walking gait test

  32. Gait Speed [ Time Frame: Post-Operative 6 weeks ]
    6 meter timed walking gait test

  33. Gait Speed [ Time Frame: Post-Operative 6 months ]
    6 meter timed walking gait test



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients aged over 45 with end stage knee OA
  • Patient has been scheduled for TKR
  • Able to comply with the assessments and has given oral and written consent

Exclusion Criteria:

  • Patients with connective tissue disorders or myositis condition
  • Previous cases of alcoholism or drug abuse
  • Pregnancy or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880344


Locations
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Hong Kong
Department of Orthopaedics & Traumatology
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Dr. Ho Ki Wai, Clinical Professional Consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03880344     History of Changes
Other Study ID Numbers: CUHK_2018.403
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Ho Ki Wai, Chinese University of Hong Kong:
vibration therapy
Knee Osteoarthritis
Knee Arthropathy

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Sarcopenia
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms