Randomized Control Trial Investigating the Effectiveness of Vibration Therapy on Sarcopenia in Osteoarthritis Knee Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Knee Flexion/Extension Strength
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Vibration Therapy (Device)
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.
Intervention: Physiotherapy (Combination Product)
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.
Intervention: Physiotherapy (Combination Product)
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
Secondary Outcomes
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC)(Post-Operative 6 months)
- IPAQ(Post-Operative 6 months)
- Knee Function measures by 6 meter Timed Walking Gait Test(Post-Operative 6 months)
- SF-12(Post-Operative 6 months)
- Whole body lean muscle mass(Post-Operative 6 months)
- Muscle Biopsy(Intra-Operatively)
- Knee Functions measure by the Knee Society Score(Post-Operative 12 months)
- Hand-grip Strength(Post-Operative 6 months)
- Gait Speed(Post-Operative 6 months)
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC)(Baseline Assessment)
- Whole body lean muscle mass(Baseline Assessment)
- Whole body lean muscle mass(Pre-Operative Assessment)
- Knee Functions measure by the Knee Society Score(Baseline Assessment)
- Knee Functions measure by the Knee Society Score(Pre-Operative Assessment)
- Knee Functions measure by the Knee Society Score(Post-Operative 6 weeks)
- Knee Functions measure by the Knee Society Score(Post-Operative 6 months)
- Gait Speed(Baseline Assessment)
- Knee Function measures by 6 meter Timed Walking Gait Test(Baseline Assessment)
- Knee Function measures by 6 meter Timed Walking Gait Test(Pre-Operative Assessment)
- Knee Function measures by 6 meter Timed Walking Gait Test(Post-Operative 6 weeks)
- SF-12(Baseline Assessment)
- Gait Speed(Pre-Operative Assessment)
- SF-12(Pre-Operative Assessment)
- SF-12(Post-Operative 6 weeks)
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC)(Pre-Operative Assessment)
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC)(Post-Operative 6 weeks)
- IPAQ(Baseline Assessment)
- IPAQ(Pre-Operative Assessment)
- IPAQ(Post-Operative 6 weeks)
- Hand-grip Strength(Baseline Assessment)
- Hand-grip Strength(Pre-Operative Assessment)
- Hand-grip Strength(Post-Operative 6 weeks)
- Gait Speed(Post-Operative 6 weeks)
Investigators
Dr. Ho Ki Wai
Clinical Professional Consultant
Chinese University of Hong Kong