NCT02928562

Brief Summary

Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative pain and swelling, protection of the healing graft, restoration of full range of motion symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee, hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional activities that are required for return to the normal daily life. The effects of concomitant injuries and surgical procedures must also be considered in planning an individualized rehabilitation program. However, it is still unclear regarding the optimal exercise prescription after TKA. In the current study, the investigators plan to develop an exercise protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density assessment. The exercise prescription consisted of cyclic exercise, aerobic exercise and resistant training exercise for first, second and third year, respectively. Cyclic exercise is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the exercise can be quantitatively determined. Aerobic exercise is privileged by the cardiopulmonary endurance improvement, along with muscle strengthening in the associated muscle groups. Resistance exercise is specified for the indicated muscle groups, especially knee extensors, flexors, ankle plantar flexor and dorsi flexor in TKA reconstructed patients. The investigators hypothesis that using this cyclic exercise process can improve the body composition, muscle strength, bone mass density, level of oxidative damage indicators, gait performance, quality of life, knee joint range of motion, function of cardiopulmonary and fitness. This project will establish the scientific basis for rehabilitation protocol involving knee surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

4.1 years

First QC Date

September 18, 2016

Last Update Submit

November 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline bone mineral density

    Bone mineral density measurement is measured by dual-energy x-ray absorptiometry (DXA). Measurements are made over the lumbar spine and over the upper part of the hip and the measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.

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

Secondary Outcomes (7)

  • Change from baseline lower extremity muscle strength

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

  • Motion analysis

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

  • Change from baseline SF-36 questionnaire assessment

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

  • Change from baseline KOOS questionnaire assessment

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

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

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

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

TKA patients without exercise intervention

Exercise

EXPERIMENTAL

TKA patients with exercise intervention ( cyclic exercise, aerobic exercise and resistant training exercise )

Other: exercise

Interventions

cyclic exercise, aerobic exercise and resistant training exercise

Exercise

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Medicine Center, Chang Gung Memorial Hospital

Chiayi City, 613, Taiwan

Location

Related Publications (1)

  • Hsu WH, Hsu WB, Shen WJ, Lin ZR, Chang SH, Hsu RW. Circuit training enhances function in patients undergoing total knee arthroplasty: a retrospective cohort study. J Orthop Surg Res. 2017 Oct 19;12(1):156. doi: 10.1186/s13018-017-0654-4.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robert Wen-Wei HSU, MD

    Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi

    PRINCIPAL INVESTIGATOR

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
Honorary Dean

Study Record Dates

First Submitted

September 18, 2016

First Posted

October 10, 2016

Study Start

October 1, 2013

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations