Clinical trial NCT02062138: Effectiveness of Passive and Active ROM Exercises Following TKA
Official title: Effectiveness of New Interventional Approaches to Improve Physical Function Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Total Knee Arthroplasty
Keywords: rehabilitation
total knee arthroplasty
range of motion
continuous passive motion
controlled active motion
postoperative physical therapy
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: range of motion
timeFrame: change from baseline (before surgery) to discharge (9 days post surgery)
Secondary outcomes:
measure: neuromuscular function
timeFrame: change from baseline (before surgery) to discharge (9 days after surgery)
measure: joint position sense
timeFrame: change from baseline (before surgery) to discharge (9 days after surgery)
measure: motor function
timeFrame: change from baseline (before surgery) to discharge (9 days after surgery)
measure: cognitive functioning
timeFrame: change from baseline (before surgery) to discharge (9 days after surgery)
measure: physical activity
timeFrame: change from baseline (before surgery) to discharge (9 days after surgery)
measure: pain
timeFrame: change from baseline (before surgery) to discharge (9 days after surgery)
measure: swelling
timeFrame: change from baseline (before surgery) to discharge (9 days after surgery)
measure: length of hospital stay
timeFrame: change from baseline (before surgery) to discharge (9 days after surgery)
measure: quality of life
timeFrame: change from baseline (before surgery) to discharge (9 days after surgery)
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Department of Orthopedics, University Medicine Rostock
Study officials:
affiliation: Department of Orthopedics, University Medicine Rostock
name: Rainer Bader, MD
role: STUDY_CHAIR
affiliation: Department of Orthopedics, University Medicine Rostock
name: Ralf Skripitz, MD
role: STUDY_DIRECTOR
affiliation: Department of Orthopedics, University Medicine Rostock
name: Anett Mau-Moeller, M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Kinesiology, University of Rostock
name: Martin Behrens
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Kinesiology, University of Rostock
name: Tino Stöckel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacksteit R, Stockel T, Behrens M, Feldhege F, Bergschmidt P, Bader R, Mittelmeier W, Skripitz R, Mau-Moeller A. Low-Load Unilateral and Bilateral Resistance Training to Restore Lower Limb Function in the Early Rehabilitation After Total Knee Arthroplasty: A Randomized Active-Controlled Clinical Trial. Front Med (Lausanne). 2021 Jun 22;8:628021. doi: 10.3389/fmed.2021.628021. eCollection 2021.