NCT03339323

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

Status unknown NA Last updated 16 March 2020

What this trial tests

NA trial testing Exercise in Knee Osteoarthritis in 210 participants. Status unknown.

Timeline

1 November 2017

Primary endpoint
31 October 2020

31 October 2020

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	210
Start date	1 November 2017
Primary completion	31 October 2020
Estimated completion	31 October 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• Exercise

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →
• Arthropathy of Knee Joint — all drugs for Arthropathy of Knee Joint →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 60 to 90, any sex, with Knee Osteoarthritis or Arthropathy of Knee Joint. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.