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

NCT03339323 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2020-03-16

No results posted yet for this study

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

Interventions

OTHER

Exercise

TKA patients do the exercise intervention

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03339323 on ClinicalTrials.gov