OsteoarthritisNCT00605124
Progressive Exercise After Total Knee Arthroplasty (TKA)
A study testing Knee muscle exercises in people with Osteoarthritis, run by Jyväskylä Central Hospital at 1 site in Finland.
Trial summary
Total knee arthroplasty (TKA) is performed more than 7.000 times a year in Finland most often for osteoarthritis (OA). While pain is predictably reduced, function does not typically ever reach that of age-matched, uninjured subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Knee muscle exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2008to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary unilateral TKA for knee osteoarthritis
Who cannot join
- Rheumatoid arthritis
- Fibromyalgia
- Bilateral TKA
- Heart or lung disease, which prevent training
- Unstable serious disease (cancer)
- Reduced cooperation (drug, alcohol abuse, mental illness)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progressive Exercise After Total Knee Arthroplasty: A Randomised Controlled Trial
Total knee arthroplasty (TKA) is performed more than 7.000 times a year in Finland most often for osteoarthritis (OA). While pain is predictably reduced, function does not typically ever reach that of age-matched, uninjured subjects. Quadriceps weakness has been implicated in the development and progression of knee OA and is a significant problem after TKA. Advance to return to normal daily activities is not sufficient to restore knee function or quadriceps strength after TKA.
The aim of this study is to assess the effectiveness of progressive exercise program restoring knee strength, mobility and improving the functional outcome after primary TKA.
Read the detailed description
Many studies have shown, that after TKA pain decreased significantly, but muscle strength of the operated knee did not recover and may stay under the preoperative level. To find out the effects of progressive exercise program the investigators will perform, 6 weeks after TKA, a randomized clinical trial of lower extremity strength training using two subgroups of people: traditional exercise group and progressive exercise group.
- Conditions
- Osteoarthritis
- Being tested
- Knee muscle exercises
- Keywords
- osteoarthritis, knee, total knee arthroplasty, exercise
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee muscle exercisesOther
Home exercises three times a week, control every three months
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | progressive exercise, home-based exercise program, tree exercise sessions weekly, chec-up visits every third month Receives: Other: Knee muscle exercises |
| Conventional treatment | Active comparator | Normal treatment, single guidance to home exercise Receives: Other: Knee muscle exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional tests, pain
Timed-Up and Go-test, Visual analogue scale (VAS)
Measured: baseline , 6 weeks after operation (start of training), after 12 months training
Secondary outcomes (3)
Knee muscle strength
isometric strength of quadriceps and hamstrings
Measured: baseline, 6 weeks after operation (start of training), after 12 months training
Health related quality of life
SF-36
Measured: baseline and 12 months
gait analysis
Measured: baseline, 6 weeks postoperatively, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jyväskylä Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirja Vuorenmaa, Jyväskylä Central Hospital
- Investigators
- Jari Ylinen, MD, PhD, Study director, Central Finland Health Care DistrictArja Häkkinen, PhD, Professor, Study chair, Central Finland Health Care DistrictPetri Salo, M.Sc., Principal investigator, Central Finland Health Care DistrictMirja Vuorenmaa, M.Sc., Principal investigator, Central Finland Health Care DistrictMaija Pesola, MD, Study chair, Central Finland Health Care District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605124
- Sponsor's protocol ID
- KSSHP Dnro6/2007
- Other IDs
- KSSHP
- Status last verified
- Mar 2013
- First submitted
- 16 Jan 2008
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Exercise After Total Knee Arthroplasty: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00605124
- Acronym / sponsor ID
- KSSHP Dnro6/2007
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, knee, total knee arthroplasty, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jyväskylä Central HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jan 2008 (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.
Total knee arthroplasty (TKA) is performed more than 7.000 times a year in Finland most often for osteoarthritis (OA). While pain is predictably reduced, function does not typically ever reach that of age-matched, uninjured subjects. Quadriceps weakness has been implicated in the development and progression of knee OA and is a significant problem after TKA. Advance to return to normal daily activities is not sufficient to restore knee function or quadriceps strength after TKA.
The aim of this study is to assess the effectiveness of progressive exercise program restoring knee strength, mobility and improving the functional outcome after primary TKA.
Detailed description
Many studies have shown, that after TKA pain decreased significantly, but muscle strength of the operated knee did not recover and may stay under the preoperative level. To find out the effects of progressive exercise program the investigators will perform, 6 weeks after TKA, a randomized clinical trial of lower extremity strength training using two subgroups of people: traditional exercise group and progressive exercise group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Other: Knee muscle exercisesprogressive exercise, home-based exercise program, tree exercise sessions weekly, chec-up visits every third month |
| Conventional treatment | Active comparator | Other: Knee muscle exercisesNormal treatment, single guidance to home exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary unilateral TKA for knee osteoarthritis
Key exclusion criteria (6 listed)
- Rheumatoid arthritis
- Fibromyalgia
- Bilateral TKA
- Heart or lung disease, which prevent training
- Unstable serious disease (cancer)
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 |
|---|---|---|
| Knee muscle exercisesHome exercises three times a week, control every three months | Other | Conventional treatment, exercise |
Primary outcome
Functional tests, pain
Time frame: baseline , 6 weeks after operation (start of training), after 12 months training
Timed-Up and Go-test, Visual analogue scale (VAS)
3 secondary outcomes
Knee muscle strength
Time frame: baseline, 6 weeks after operation (start of training), after 12 months training
Health related quality of life
Time frame: baseline and 12 months
gait analysis
Time frame: baseline, 6 weeks postoperatively, 12 months
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 5 Mar 2013.
Related trials for Osteoarthritis
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Osteoarthritis, Knee, Chronic Pain
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis
Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
Not yet recruiting
Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes
Knee Osteoarthritis
Recruiting
Study NRPT Feasibility in Knee Osteoarthritis
Knee Osteoarthristis
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.
Jari Ylinen, MD, PhD study director
Central Finland Health Care District
Arja Häkkinen, PhD, Professor study chair
Central Finland Health Care District
Petri Salo, M.Sc. principal investigator
Central Finland Health Care District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee muscle exercises in people with Osteoarthritis, run by Jyväskylä Central Hospital at 1 site in Finland.
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 1 inclusion and 6 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 5 Mar 2013. 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 Finland. 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?
Functional tests, pain (time frame: baseline , 6 weeks after operation (start of training), after 12 months training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2013.