The Effect of Exercise Training on Muscle Mass in Patients With Total Knee Arthroplasty

NCT03339323 | Unknown

• 1 other identifier: CORPG6G0261-3
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Total knee arthroplasty (TKA) is one of the most common operations in orthopedics. After surgery, the decline of bone mineral density and muscle mass was proved, oral bisphosphonate is commonly used to prevent BMD loss in clinic treatment, however, the loss of muscle mass can only be maintained with exercise intervention. The goals of TKA rehabilitation should be based on control pain, improve ambulation, maximize the range of motion, develop muscle strength, and provide emotional support. We planned to find out a potential adjuvant effective option in muscle mass for the management of post-TKA. Literature suggested that exercise training has been found to have the considerable effect on TKA. However, no suitable exercise prescription was established on the scientific basis. The current study aimed to find out a potential treatment mode. Study Rationale: This project will be performed for consecutive three years, the patients with post-TKA patients are managed with the treadmill exercise training in the first year. In the second year, resistance exercise is prescribed. In the third year, eccentric exercise plus resistance training will be arranged in the exercise group. We will analyze the data of the three years and cross-comparative analysis. A prescription of exercise training, a period of 24 weeks each year, 3 times a week, for each 10 minutes warm-up, 40 minutes exercise training, and 10-minute cool down for exercise prescription Study Objectives: To investigate the effect of long-term exercise training, eccentric and resistance exercise on muscle mass in patients with total knee arthroplasty. To monitor the performance index included: physiological indices, muscle mass, ambulation and the quality of life index. Study Design Duration of Treatment: Total of 6-month exercise intervention in each year. The number of Planned Patients: 35 subjects in each control and exercise group in one year, the total of 210 subjects in three years. Investigational Product: Automated biochemistry analyzer, Biospace Inbody 7.20 Analysis of body composition instrumentation; Dual Energy X-ray Absorptiometer (DEXA), isokinetic muscle strength measurement, VICON to analysis ambulation, functional fitness, the questionnaire including SF-36, KOOS and VAS pain score. Endpoints: Data collection in pre-surgery, 3 months, 6 months, 9 months and 12 months after surgery.

Conditions

Knee Osteoarthritis; Arthropathy of Knee Joint

Outcome Measures

Primary Outcomes (1)

• Change from baseline muscle mass

  Muscle mass measurement is measured by dual-energy x-ray absorptiometry (DXA). DXA measures the muscle mass of the whole body and the measurement is assessed at pre-operation, three months, six months and nine months after the operation, and twelve-month follow-up.

  Baseline; three month ; six month and nine month after operation; twelve-month follow-up

Secondary Outcomes (7)

• Change from baseline lower extremity muscle strength

  Baseline; three month ; six month and nine month after operation; twelve-month follow-up

• Motion analysis

  Baseline; three month ; six month and nine month after operation; twelve-month follow-up

• Change from baseline SF-36 questionnaire assessment

  Baseline; three month ; six month and nine month after operation; twelve-month follow-up

• Change from baseline KOOS questionnaire assessment

  Baseline; three month ; six month and nine month after operation; twelve-month follow-up

• Physical fitness---6-minutes' walk test

  Baseline; three month , six month and nine month after operation; twelve-month follow-up

Study Arms (2)

Control

NO INTERVENTION

Standard rehabilitation procedure

Exercise

EXPERIMENTAL

Aerobic exercise combined with resistance training; Concentric resistance training; Eccentric resistance training

Other: Exercise

Interventions

Exercise OTHER

TKA patients do the exercise intervention

Exercise

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Sports Medicine Center, Chang Gung Memorial Hospital

Chiayi City, 613, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Robert Wen-Wei HSU, MD

CONTACT

+886-5-362-1000; wwh@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: November 1, 2017
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

TW (1)