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

Primary Purpose

Knee Arthropathy, Osteoarthritis, Knee, Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Vibration Therapy
Physiotherapy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Arthropathy focused on measuring vibration therapy, Knee Osteoarthritis, Knee Arthropathy

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Orthopaedics & TraumatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vibration Therapy + Normal Out-Patient Physiotherapy

Normal Out-Patient Department Physiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Knee Flexion/Extension Strength
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.
Knee Flexion/Extension Strength
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.
Knee Flexion/Extension Strength
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.
Knee Flexion/Extension Strength
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.
Knee Flexion/Extension Strength
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

Whole body lean muscle mass
DXA measurement scan
Whole body lean muscle mass
DXA measurement scan
Whole body lean muscle mass
DXA measurement scan
Muscle Biopsy
Types of muscle fibers and satellite cells as Assessed by Muscle Biopsy Assessment
Knee Functions measure by the Knee Society Score
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.
Knee Functions measure by the Knee Society Score
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.
Knee Functions measure by the Knee Society Score
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.
Knee Functions measure by the Knee Society Score
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.
Knee Functions measure by the Knee Society Score
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.
Knee Function measures by 6 meter Timed Walking Gait Test
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).
Knee Function measures by 6 meter Timed Walking Gait Test
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).
Knee Function measures by 6 meter Timed Walking Gait Test
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).
Knee Function measures by 6 meter Timed Walking Gait Test
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).
SF-12
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.
SF-12
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.
SF-12
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.
SF-12
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.
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
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.
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
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.
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
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.
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
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.
IPAQ
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.
IPAQ
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.
IPAQ
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.
IPAQ
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.
Hand-grip Strength
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Hand-grip Strength
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Hand-grip Strength
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Hand-grip Strength
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Gait Speed
6 meter timed walking gait test
Gait Speed
6 meter timed walking gait test
Gait Speed
6 meter timed walking gait test
Gait Speed
6 meter timed walking gait test

Full Information

First Posted
March 6, 2019
Last Updated
March 21, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03880344
Brief Title
Investigating the Effectiveness of Vibration Therapy on Sarcopenia in Osteoarthritis Knee Patients
Official Title
Randomized Control Trial Investigating the Effectiveness of Vibration Therapy on Sarcopenia in Osteoarthritis Knee Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

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
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.
Detailed Description
Patients with end stage OA often adopt a sedentary lifestyle causing mobility and functionality decline to avoid joint pain and stiffness. This dysfunctions a series of antioxidant response cascades which eventually leads to muscle atrophy of the knee. Notably, muscle atrophy and weakness (i.e. sarcopenia) often accompanies with OA. However the relationship between these symptoms and OA remains undefined and no strong consensus have been made thus far. Our ongoing longitudinal study on muscle strength and functionality which investigates the prevalence of sarcopenia in end stage OA patient's pre and post operation (Total Knee Replacement) have reflected that 24% with severe knee OA patients also suffered sarcopenia. In addition, these patients also showed a much slower recovery and longer length of stay in hospital after undergoing surgical operation. The effect of clinical sarcopenia affects our locomotion system in the aging population. Weakness in patients and decline in muscle strength results in significant functional impairment are often seen in the cohort, leading to fragility, falls, fractures and disability. Many authors have tried to explain the pathophysiology of sarcopenia in an attempt to link the disorder to a molecular or biochemical level in numerous literature. Satellite cells (a myogenic stem cell), Insulin like growth factor 1 (IGF-1) (an important mediator of muscle growth and regeneration affecting muscle function) and fast twitch muscle fibres are three major molecular composites that have been widely studied. Evidence have suggested the close relationship between them and muscle atrophy and weakness. However, these studies have either shown the results from an animal standpoint or they lack specificity and further research is necessary to confirm their role in patients suffering from sarcopenia. Attempts have also been made to discover the most effective intervention to treat or even eliminate the chances of sarcopenia. Among these studies resistance exercises have been documented the most. Evidence showed that progressive resistance and aerobic exercises are most beneficial for the prevention and treatment of sarcopenia. Resistant training that such as lifting weights, strength resistance bands, resistance machines has shown to improve protein synthesis in skeletal muscle cells leading to better muscle strength and mass, leading to muscle hypertrophy and promotes muscle power. Our previous knowledge transfer study on developing an aerobic exercise (i.e. Tai Chi Exercise) for end stage OA patients also showed similar positive effects in subjects, decreasing their pain and stiffness symptoms and limitations in physical activity. Though resistance exercise showed promising effects, are safe and strongly advised interventions based on documented and our previous study, the elderly populations often accompanies with other physical symptoms (such as back pain) and diminished fine motor skills that may limit their range of movement in these exercise regimes. In addition, resistive exercises are extremely technical and is essential to execute with proper form to avoid further injury; hence these exercises are unable to perform safely alone at home, making the intervention less autonomous. Vibration therapy is a noninvasive biophysical modality and has been demonstrated in a number of studies showing multiple positive effects in terms of postural control, balancing ability, circulation and most importantly muscle strength. Two of our previous studies investigated the long term effects on muscle performance and bone quality in using low-magnitude high frequency vibration. Though the results showed that the treatment is an effective method in fall prevention by improving on both frontiers, these two studies' main subject focuses were on the elderly population as a whole. A study pivoting on subjects with co-existing diagnosis of sarcopenia and OA is crucial to investigate the effectiveness of this therapy method. Limited studies have shown positive effects of vibration therapy on osteoarthritis, however, these studies were limited to a single gender (i.e. females) or contained subject recruitment bias or assessment period of less than 6 months. A randomized control trial with a longer assessment period is essential to investigate the true effects of vibration therapy on knee OA patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy, Osteoarthritis, Knee, Knee Osteoarthritis
Keywords
vibration therapy, Knee Osteoarthritis, Knee Arthropathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vibration Therapy + Normal Out-Patient Physiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal Out-Patient Department Physiotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vibration Therapy
Intervention Description
Vibration therapy as a pre-operative rehabilitation programme 3 times a week for 3 months + Normal Regular out-patient department physiotherapy
Intervention Type
Combination Product
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy as post-operative rehabilitation programme for 6 months.
Primary Outcome Measure Information:
Title
Knee Flexion/Extension Strength
Description
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.
Time Frame
Baseline Assessment
Title
Knee Flexion/Extension Strength
Description
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.
Time Frame
Pre-Operative Assessment
Title
Knee Flexion/Extension Strength
Description
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.
Time Frame
Post-Operative 6 weeks
Title
Knee Flexion/Extension Strength
Description
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.
Time Frame
Post-Operative 6 months
Title
Knee Flexion/Extension Strength
Description
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.
Time Frame
Post-Operative 12 months
Secondary Outcome Measure Information:
Title
Whole body lean muscle mass
Description
DXA measurement scan
Time Frame
Baseline Assessment
Title
Whole body lean muscle mass
Description
DXA measurement scan
Time Frame
Pre-Operative Assessment
Title
Whole body lean muscle mass
Description
DXA measurement scan
Time Frame
Post-Operative 6 months
Title
Muscle Biopsy
Description
Types of muscle fibers and satellite cells as Assessed by Muscle Biopsy Assessment
Time Frame
Intra-Operatively
Title
Knee Functions measure by the Knee Society Score
Description
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.
Time Frame
Baseline Assessment
Title
Knee Functions measure by the Knee Society Score
Description
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.
Time Frame
Pre-Operative Assessment
Title
Knee Functions measure by the Knee Society Score
Description
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.
Time Frame
Post-Operative 6 weeks
Title
Knee Functions measure by the Knee Society Score
Description
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.
Time Frame
Post-Operative 6 months
Title
Knee Functions measure by the Knee Society Score
Description
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.
Time Frame
Post-Operative 12 months
Title
Knee Function measures by 6 meter Timed Walking Gait Test
Description
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).
Time Frame
Baseline Assessment
Title
Knee Function measures by 6 meter Timed Walking Gait Test
Description
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).
Time Frame
Pre-Operative Assessment
Title
Knee Function measures by 6 meter Timed Walking Gait Test
Description
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).
Time Frame
Post-Operative 6 weeks
Title
Knee Function measures by 6 meter Timed Walking Gait Test
Description
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).
Time Frame
Post-Operative 6 months
Title
SF-12
Description
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.
Time Frame
Baseline Assessment
Title
SF-12
Description
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.
Time Frame
Pre-Operative Assessment
Title
SF-12
Description
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.
Time Frame
Post-Operative 6 weeks
Title
SF-12
Description
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.
Time Frame
Post-Operative 6 months
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Baseline Assessment
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Pre-Operative Assessment
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Post-Operative 6 weeks
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Post-Operative 6 months
Title
IPAQ
Description
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.
Time Frame
Baseline Assessment
Title
IPAQ
Description
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.
Time Frame
Pre-Operative Assessment
Title
IPAQ
Description
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.
Time Frame
Post-Operative 6 weeks
Title
IPAQ
Description
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.
Time Frame
Post-Operative 6 months
Title
Hand-grip Strength
Description
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Time Frame
Baseline Assessment
Title
Hand-grip Strength
Description
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Time Frame
Pre-Operative Assessment
Title
Hand-grip Strength
Description
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Time Frame
Post-Operative 6 weeks
Title
Hand-grip Strength
Description
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Time Frame
Post-Operative 6 months
Title
Gait Speed
Description
6 meter timed walking gait test
Time Frame
Baseline Assessment
Title
Gait Speed
Description
6 meter timed walking gait test
Time Frame
Pre-Operative Assessment
Title
Gait Speed
Description
6 meter timed walking gait test
Time Frame
Post-Operative 6 weeks
Title
Gait Speed
Description
6 meter timed walking gait test
Time Frame
Post-Operative 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Orthopaedics & Traumatology
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd
Phone
(852) 3505 2715
Email
kevinho@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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