Effectiveness of Passive and Active ROM Exercises Following TKA

May 19, 2017 updated by: Anett Mau-Moeller, University of Rostock

Effectiveness of New Interventional Approaches to Improve Physical Function Following Total Knee Arthroplasty

The purpose of the study is to determine the effectiveness of new interventional approaches in the early postoperative phase following total knee arthroplasty (TKA). It is assumed that active training programs are more effective in improving physical function than the passive standard-of-care therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The major objectives of rehabilitation after TKA are the early regain of range of motion (ROM) and mobilization of the patient. Continuous passive motion (CPM) is frequently used as part of the postoperative care regime following TKA with the aim to increase knee joint mobility and improve postoperative recovery despite little conclusive scientific evidence. Conflicting research findings have generated an ongoing debate on its usage. As the greatest loss of function occurs in the first month following TKA, it is surprising that the ROM therapy during hospital stay is still carried out passively. A passive mobilization of the knee joint with CPM does not encourage the patients to actively participate in their rehabilitation. Research on the effectiveness of active ROM exercises added to standard physiotherapy during the short in-hospital period is lacking so far.The objective of this study is to compare the passive clinical standard therapy (CPM) with different active training programs (controlled active motion, CAM). It was hypothesised that the CAM therapies are more effective in improving physical function than the CPM therapy.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Rostock, Germany, 18057
        • Department of Orthopedics, University Medicine Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with knee osteoarthritis and scheduled for primary TKA
  • age: 50-80

Exclusion Criteria:

  • BMI > 40
  • musculoskeletal and neurological disorders that limit physical function
  • any planned further joint surgery within 6 months
  • substantial pain or functional limitation which make the patients unable to perform study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: continuous passive motion (CPM)
Other: continuous passive motion (CPM)
standard-of-care therapy (control intervention); Patients receive three 30 minutes CPM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.
EXPERIMENTAL: controlled active motion (CAM I)
Other: controlled active motion (CAM I)
Patients receive three 30 minutes CAM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.
EXPERIMENTAL: controlled active motion (CAM II)
Other: controlled active motion (CAM II)
Patients receive three 30 minutes CAM applications (bilateral alternating) each day from the second postoperative day until 1 day prior to discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
range of motion
Time Frame: change from baseline (before surgery) to discharge (9 days post surgery)
change from baseline (before surgery) to discharge (9 days post surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neuromuscular function
Time Frame: change from baseline (before surgery) to discharge (9 days after surgery)
change from baseline (before surgery) to discharge (9 days after surgery)
joint position sense
Time Frame: change from baseline (before surgery) to discharge (9 days after surgery)
change from baseline (before surgery) to discharge (9 days after surgery)
motor function
Time Frame: change from baseline (before surgery) to discharge (9 days after surgery)
stair climbing test, timed up and go test
change from baseline (before surgery) to discharge (9 days after surgery)
cognitive functioning
Time Frame: change from baseline (before surgery) to discharge (9 days after surgery)
change from baseline (before surgery) to discharge (9 days after surgery)
physical activity
Time Frame: change from baseline (before surgery) to discharge (9 days after surgery)
over a period of 7 days using the activPAL activity recording system.
change from baseline (before surgery) to discharge (9 days after surgery)
pain
Time Frame: change from baseline (before surgery) to discharge (9 days after surgery)
visual analogue scale (VAS)
change from baseline (before surgery) to discharge (9 days after surgery)
swelling
Time Frame: change from baseline (before surgery) to discharge (9 days after surgery)
change from baseline (before surgery) to discharge (9 days after surgery)
length of hospital stay
Time Frame: change from baseline (before surgery) to discharge (9 days after surgery)
change from baseline (before surgery) to discharge (9 days after surgery)
quality of life
Time Frame: change from baseline (before surgery) to discharge (9 days after surgery)
36-item Short Form Health Survey (SF-36)
change from baseline (before surgery) to discharge (9 days after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Investigators

  • Study Chair: Rainer Bader, MD, Department of Orthopedics, University Medicine Rostock
  • Study Director: Ralf Skripitz, MD, Department of Orthopedics, University Medicine Rostock

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

February 6, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (ESTIMATE)

February 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 22, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPAB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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