OsteoarthritisPhase 4PrehabOANCT02881463
Prehabilitation Physical Activity in Persons With Osteoarthritis
A Phase 4 study testing therapeutical exercises in people with Osteoarthritis, run by University of Tartu.
Trial summary
Knee joint osteoarthritis (OA) reduces functional mobility and performance of daily tasks such as rising from a chair. Therefore interventions aimed at improving muscle strength and sit-to-stand task performance are very important for these patients. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- therapeutical exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2016
- Phase
- Phase 4
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For OA patients: patients with severe knee joint OA undergoing unilateral total knee arthroplasty (TKA)
- for controls: pain of joints more than 20/100 mm by VAS
Who cannot join
- For both groups:
- previous total joint arthroplasty of lower limbs
- other musculoskeletal, neurological and cardiovascular diseases
- any diseases affecting balance and coordination.
About this study
Official title: Prehabilitation Physical Activity: Relationship With Muscle Function, Postural Stability and Postoperative Recovery in Persons With Osteoarthritis
Knee joint osteoarthritis (OA) reduces functional mobility and performance of daily tasks such as rising from a chair. Therefore interventions aimed at improving muscle strength and sit-to-stand task performance are very important for these patients. The effect of exercise programs, including home exercise programs (HEP), on muscle strength, joint pain and function is well known and widely researched, yet not many studies have investigated the effect of an HEP on electromyographic activity (EMG) of muscles when performing everyday tasks, such as rising from and sitting on a chair. The aim of this study was to investigate effect of prehabilitation in women with severe knee joint OA scheduled for knee joint arthroplasty (TKA).
- Conditions
- Osteoarthritis
- Being tested
- therapeutical exercises
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutical exercisesOther
Participants of experimental group performs daily an 8-week home therapeutical exercise program. Exercises are periodized by weeks (1-8 weeks). The aim of program is the leg muscle strengthening using an elastic band (Thera-Band, System of Progressive Exercise, USA), body balance training, and leg muscle stretching.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Program | Experimental | 8- week therapeutical exercise program performing at home for women with knee joint osteoarthritis Receives: Other: therapeutical exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle electromyographic (EMG) activity
Electromyographic (EMG) activity of thigh muscles during gait and sit to stand task (amplitude, mV)
Measured: up to 12 months
Secondary outcomes (7)
Knee joint pain intensity
Self-reported knee joint pain intensity measured by visual-analogue scale (VAS) (in mm: "0 mm" - no pain and "100 mm" - extreme pain)
Measured: up to 12 months
Knee joint function
Self-reported functional status measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms, Pain, Daily Living Activity, Sport and Recreational Activity. Quality of Life. Maximum is 100 points (complains are absent) and minimum is 0 points (extreme complains)
Measured: up to 12 months
Sit to Stand test
five time Sit to Stand test from standard chair (s)
Measured: up to 12 months
Mobility test
Timed Up and Go test, 3-m plus return 3-m walking test (s)
Measured: up to 12 months
Leg muscles strength
strength of leg extensor muscles (N)
Measured: up to 12 months
Body balance
Body postural sway measuring during standing using Kistler force plate (Switzerland) (mm), eyes open and eyes closed
Measured: up to 12 months
Gait pattern
Gait kinematic characteristics measurement using three-dimensional movement analysis system and six optoelectronic cameras (BTS S.p.A. Italy) - joint angles (degrees)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionJun 2016
- Study completionJun 2016
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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Gapeyeva, University of Tartu
- Investigators
- Helena Gapeyeva, MD, PhD, Principal investigator, University of Tartu, Faculty of Medicine, Estonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881463
- Sponsor's protocol ID
- 218/T-16
- Acronym
- PrehabOA
- Status last verified
- Sep 2016
- First submitted
- 16 Jun 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation Physical Activity: Relationship With Muscle Function, Postural Stability and Postoperative Recovery in Persons With Osteoarthritis
- ClinicalTrials.gov ID
- NCT02881463
- Acronym / sponsor ID
- PrehabOA / 218/T-16
- Conditions
- Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Aug 2016 (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.
Knee joint osteoarthritis (OA) reduces functional mobility and performance of daily tasks such as rising from a chair. Therefore interventions aimed at improving muscle strength and sit-to-stand task performance are very important for these patients. The effect of exercise programs, including home exercise programs (HEP), on muscle strength, joint pain and function is well known and widely researched, yet not many studies have investigated the effect of an HEP on electromyographic activity (EMG) of muscles when performing everyday tasks, such as rising from and sitting on a chair. The aim of this study was to investigate effect of prehabilitation in women with severe knee joint OA scheduled for knee joint arthroplasty (TKA).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Program | Experimental | Other: therapeutical exercises8- week therapeutical exercise program performing at home for women with knee joint osteoarthritis |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For OA patients: patients with severe knee joint OA undergoing unilateral total knee arthroplasty (TKA)
- for controls: pain of joints more than 20/100 mm by VAS
Key exclusion criteria (4 listed)
- previous total joint arthroplasty of lower limbs
- other musculoskeletal, neurological and cardiovascular diseases
- any diseases affecting balance and coordination.
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 |
|---|---|---|
| therapeutical exercisesParticipants of experimental group performs daily an 8-week home therapeutical exercise program. Exercises are periodized by weeks (1-8 weeks). The aim of program is the leg muscle strengthening using an elastic band (Thera-Band, System of Progressive Exercise, USA), body balance training, and leg muscle stretching. | Other | Home Exercise Program |
Primary outcome
Muscle electromyographic (EMG) activity
Time frame: up to 12 months
Electromyographic (EMG) activity of thigh muscles during gait and sit to stand task (amplitude, mV)
7 secondary outcomes
Knee joint pain intensity
Time frame: up to 12 months
Knee joint function
Time frame: up to 12 months
Sit to Stand test
Time frame: up to 12 months
Mobility test
Time frame: up to 12 months
Leg muscles strength
Time frame: up to 12 months
Body balance
Time frame: up to 12 months
Gait pattern
Time frame: up to 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 13 Sep 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Helena Gapeyeva, MD, PhD principal investigator
University of Tartu, Faculty of Medicine, Estonia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing therapeutical exercises in people with Osteoarthritis, run by University of Tartu.
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 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Muscle electromyographic (EMG) activity (time frame: up to 12 months). 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 13 Sep 2016.