OsteoarthritisNCT02062138
Effectiveness of Passive and Active ROM Exercises Following TKA
A study testing continuous passive motion (CPM) in people with Osteoarthritis and Total Knee Arthroplasty, run by University of Rostock at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- continuous passive motion (CPM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with knee osteoarthritis and scheduled for primary TKA
- age: 50-80
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Orthopedics, University Medicine Rostock
Rostock, 18057
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Total Knee Arthroplasty
- Being tested
- continuous passive motion (CPM), controlled active motion (CAM I), controlled active motion (CAM II)
- Keywords
- rehabilitation, total knee arthroplasty, range of motion, continuous passive motion, controlled active motion, postoperative physical therapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous passive motion (CPM)Other
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.
controlled active motion (CAM I)Other
Patients receive three 30 minutes CAM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.
controlled active motion (CAM II)Other
Patients receive three 30 minutes CAM applications (bilateral alternating) each day from the second postoperative day until 1 day prior to discharge.
| Study group | Role | What they receive |
|---|---|---|
| continuous passive motion (CPM) | Active comparator | Not described Receives: Other: continuous passive motion (CPM) |
| controlled active motion (CAM I) | Experimental | Not described Receives: Other: controlled active motion (CAM I) |
| controlled active motion (CAM II) | Experimental | Not described Receives: Other: controlled active motion (CAM II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
Measured: change from baseline (before surgery) to discharge (9 days post surgery)
Secondary outcomes (9)
neuromuscular function
Measured: change from baseline (before surgery) to discharge (9 days after surgery)
joint position sense
Measured: change from baseline (before surgery) to discharge (9 days after surgery)
motor function
stair climbing test, timed up and go test
Measured: change from baseline (before surgery) to discharge (9 days after surgery)
cognitive functioning
Measured: change from baseline (before surgery) to discharge (9 days after surgery)
physical activity
over a period of 7 days using the activPAL activity recording system.
Measured: change from baseline (before surgery) to discharge (9 days after surgery)
pain
visual analogue scale (VAS)
Measured: change from baseline (before surgery) to discharge (9 days after surgery)
swelling
Measured: change from baseline (before surgery) to discharge (9 days after surgery)
length of hospital stay
Measured: change from baseline (before surgery) to discharge (9 days after surgery)
quality of life
36-item Short Form Health Survey (SF-36)
Measured: change from baseline (before surgery) to discharge (9 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anett Mau-Moeller, University of Rostock
- Investigators
- Rainer Bader, MD, Study chair, Department of Orthopedics, University Medicine RostockRalf Skripitz, MD, Study director, Department of Orthopedics, University Medicine RostockAnett Mau-Moeller, M.A., Principal investigator, Department of Orthopedics, University Medicine RostockMartin Behrens, Principal investigator, Department of Kinesiology, University of RostockTino Stöckel, PhD, Principal investigator, Department of Kinesiology, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062138
- Sponsor's protocol ID
- EPAB
- Status last verified
- May 2017
- First submitted
- 6 Feb 2014
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34239883
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of New Interventional Approaches to Improve Physical Function Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02062138
- Acronym / sponsor ID
- EPAB
- Conditions
- Osteoarthritis, Total Knee Arthroplasty
- Keywords
- rehabilitation, total knee arthroplasty, range of motion, continuous passive motion, controlled active motion, postoperative physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| continuous passive motion (CPM) | Active comparator | Other: continuous passive motion (CPM) |
| controlled active motion (CAM I) | Experimental | Other: controlled active motion (CAM I) |
| controlled active motion (CAM II) | Experimental | Other: controlled active motion (CAM II) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with knee osteoarthritis and scheduled for primary TKA
- age: 50-80
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | continuous passive motion (CPM) |
| 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. | Other | controlled active motion (CAM I) |
| 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. | Other | controlled active motion (CAM II) |
Primary outcome
range of motion
Time frame: change from baseline (before surgery) to discharge (9 days post surgery)
9 secondary outcomes
neuromuscular function
Time frame: 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)
motor function
Time frame: 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)
physical activity
Time frame: 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)
swelling
Time frame: 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)
quality of life
Time frame: change from baseline (before surgery) to discharge (9 days after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Derived from this study: PubMed 34239883Jacksteit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Bader, MD study chair
Department of Orthopedics, University Medicine Rostock
Ralf Skripitz, MD study director
Department of Orthopedics, University Medicine Rostock
Anett Mau-Moeller, M.A. principal investigator
Department of Orthopedics, University Medicine Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous passive motion (CPM) in people with Osteoarthritis and Total Knee Arthroplasty, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion (time frame: change from baseline (before surgery) to discharge (9 days post surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02062138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.