OsteoarthritisNCT02562833
The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis
A study testing Self-Management and exercise and Educational in people with Osteoarthritis, run by Technical University of Lisbon.
Trial summary
The PLE²NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a self-management and exercise program specific for elderly with knee osteoarthritis (OA), with the goals of managing OA symptoms, improving physical fitness, and developing self-efficacy and self-management of pathology. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Self-Management and exercise and Educational
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Oct 2015
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over than or equal to 60 years;
- Bilateral or unilateral OA of the knee diagnosed according to clinical and radiological criteria of the American College of Rheumatology (ACR)(Altman et al., 1986);
- Independent mobility;
- and reading and writing knowledge.
Who cannot join
- Not be involved in another intervention program (exercise, education or physical therapy;
- Do not use supplements (chondroitin sulfate and / or glucosamine) for at least three months;
- Have other pathology (cardiovascular, respiratory, musculoskeletal, cancer) that prevents physical exercise;
- Mental / psychological state hindering understanding of the program;
- Having undergone surgery for knee replacement or going perform this surgery in the next eight months;
- Being allergic to shellfish;
- Have made injections of corticosteroids or hyaluronic acid in the last 6 months
About this study
Official title: The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis: A Randomized Controlled Trial
The PLE²NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a self-management and exercise program specific for elderly with knee osteoarthritis (OA), with the goals of managing OA symptoms, improving physical fitness, and developing self-efficacy and self-management of pathology.
Read the detailed description
Participants were randomly assigned to one of two groups: (1) Self-management and Exercise (2) Educational. Both groups received glucosamine and chondroitin sulfate supplement during the intervention. Blinding of participants was not possible due to the nature of the intervention; however, assessors were blinded to group allocation. The PLE2NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a community-based program with two components: self-management and exercise. Each session lasted 90 minutes, and the first 30 minutes corresponded to a self-management part and the remaining 60 minutes to the exercise program. The program was offered in a group format, encouraging peer interactions and socialization that can help counteract feelings of depression and isolation. The self-management program is based on the program developed at Stanford University, the Chronic Disease Self-Management Program which the purpose is developing self-efficacy based on social cognitive theory. The exercise program comprised both health related (strength, flexibility) and skill-related (agility, balance, speed and power) physical fitness components, and was based on Fit an Strong Program, on Exercise for People with Arthritis (FEPA) and also on the program Takin Control with Exercise (Arthritis Foundation). The program will last for 3 months and 6 months of follow-up.
- Conditions
- Osteoarthritis
- Being tested
- Self-Management and exercise, Educational
- Keywords
- Osteoarthritis, Self-management, Multi-Component Exercise
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management and exerciseDevice
Self-Management and exercise It is a 3 months intervention where the participants were enrolled two times per week, 90 minutes each session, first 30 minutes were allocated for the self-management component and the remaining 60 minutes for the exercise component. Additionally,participants received glucosamine and chondroitin sulfate supplement.
EducationalDevice
This group received an educational book with information about OA features, treatment modalities and exercise education with illustration. Additionally, a monthly educational session each with one hour and a half duration, in total 3, where joint protections strategies, OA self-management and exercise contents were transmitted. Additionally,participants received glucosamine and chondroitin sulfate supplement.
| Study group | Role | What they receive |
|---|---|---|
| Self-Management and exercise | Experimental | Not described Receives: Device: Self-Management and exercise |
| Educational | Active comparator | Not described Receives: Device: Educational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline knee OA symptoms to 3 month, assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire.
Measured: Change from baseline to 3 month
Change from baseline self-efficacy to 3 month, assessed by Self-efficacy for managing Chronic Disease - 6-Item Scale questionnaire.
Measured: Change from baseline to 3 month
Change from baseline functional strength to 3 month, assessed by Five repetition sit to stand test.
Measured: Change from baseline to 3 month
Change from baseline cardiorespiratory endurance to 3 month, assessed by Six Minutes' Walk test.
Measured: Change from baseline to 3 month
Change from baseline flexibility to 3 month, assessed by Chair Sit and Reach test, and the Back Scratch test.
Measured: Change from baseline to 3 month
Change from baseline hand grip strength to 3 month, assessed by hand grip dynamometer test.
Measured: Change from baseline to 3 month
Secondary outcomes (6)
Change from baseline health related quality of life to 3 month, assessed by perception of health and quality of life five dimension, five levels (EuroQol - EQ-5D-5L) questionnaire.
Measured: Change from baseline to 3 month
Change from baseline self-management behaviors to 3 month, Use of cognitive symptom management techniques, Communication with Physicians questionnaires.
Measured: Change from baseline to 3 month
Change from baseline physical activity level to 3 month, assessed by International Physical Activity Questionnaire (IPAQ).
Measured: Change from baseline to 3 month
Change from baseline gait speed to 3 month, assessed by Six-meters test.
Measured: Change from baseline to 3 month
Change from baseline balance to 3 month, assessed by Standing Balance test.
Measured: Change from baseline to 3 month
Change from baseline mobility to 3 month, assessed by Timed "up-and-go" test.
Measured: Change from baseline to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2015
- Study completionOct 2015
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscila Marconcin, Technical University of Lisbon
- Investigators
- Priscila Marconcin, Master, Principal investigator, Faculty of Human Kinetics, Lisbon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562833
- Sponsor's protocol ID
- PLENO-FMH-1
- Status last verified
- Apr 2016
- First submitted
- 23 Sep 2015
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Marconcin P, Espanha M, Yazigi F, Campos P. The PLE(2)NO self-management and exercise program for knee osteoarthritis: Study Protocol for a Randomized Controlled Trial. BMC Musculoskelet Disord. 2016 Jun 7;17:250. doi: 10.1186/s12891-016-1115-7.
PubMed 27267755
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02562833
- Acronym / sponsor ID
- PLENO-FMH-1
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Self-management, Multi-Component Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Technical University of LisbonUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Sep 2015 (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 PLE²NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a self-management and exercise program specific for elderly with knee osteoarthritis (OA), with the goals of managing OA symptoms, improving physical fitness, and developing self-efficacy and self-management of pathology.
Detailed description
Participants were randomly assigned to one of two groups: (1) Self-management and Exercise (2) Educational. Both groups received glucosamine and chondroitin sulfate supplement during the intervention. Blinding of participants was not possible due to the nature of the intervention; however, assessors were blinded to group allocation. The PLE2NO (in Portuguese Education and Exercise Free Program for osteoarthritis) is a community-based program with two components: self-management and exercise. Each session lasted 90 minutes, and the first 30 minutes corresponded to a self-management part and the remaining 60 minutes to the exercise program. The program was offered in a group format, encouraging peer interactions and socialization that can help counteract feelings of depression and isolation. The self-management program is based on the program developed at Stanford University, the Chronic Disease Self-Management Program which the purpose is developing self-efficacy based on social cognitive theory. The exercise program comprised both health related (strength, flexibility) and skill-related (agility, balance, speed and power) physical fitness components, and was based on Fit an Strong Program, on Exercise for People with Arthritis (FEPA) and also on the program Takin Control with Exercise (Arthritis Foundation). The program will last for 3 months and 6 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Management and exercise | Experimental | Device: Self-Management and exercise |
| Educational | Active comparator | Device: Educational |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over than or equal to 60 years;
- Bilateral or unilateral OA of the knee diagnosed according to clinical and radiological criteria of the American College of Rheumatology (ACR)(Altman et al., 1986);
- Independent mobility;
- and reading and writing knowledge.
Key exclusion criteria (7 listed)
- Not be involved in another intervention program (exercise, education or physical therapy;
- Do not use supplements (chondroitin sulfate and / or glucosamine) for at least three months;
- Have other pathology (cardiovascular, respiratory, musculoskeletal, cancer) that prevents physical exercise;
- Mental / psychological state hindering understanding of the program;
- Having undergone surgery for knee replacement or going perform this surgery in the next eight months;
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 |
|---|---|---|
| Self-Management and exerciseSelf-Management and exercise It is a 3 months intervention where the participants were enrolled two times per week, 90 minutes each session, first 30 minutes were allocated for the self-management component and the remaining 60 minutes for the exercise component. Additionally,participants received glucosamine and chondroitin sulfate supplement. | Device | Self-Management and exercise |
| EducationalThis group received an educational book with information about OA features, treatment modalities and exercise education with illustration. Additionally, a monthly educational session each with one hour and a half duration, in total 3, where joint protections strategies, OA self-management and exercise contents were transmitted. Additionally,participants received glucosamine and chondroitin sulfate supplement. | Device | Educational |
Primary outcome
Change from baseline knee OA symptoms to 3 month, assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire.
Time frame: Change from baseline to 3 month
Change from baseline self-efficacy to 3 month, assessed by Self-efficacy for managing Chronic Disease - 6-Item Scale questionnaire.
Time frame: Change from baseline to 3 month
Change from baseline functional strength to 3 month, assessed by Five repetition sit to stand test.
Time frame: Change from baseline to 3 month
Change from baseline cardiorespiratory endurance to 3 month, assessed by Six Minutes' Walk test.
Time frame: Change from baseline to 3 month
Change from baseline flexibility to 3 month, assessed by Chair Sit and Reach test, and the Back Scratch test.
Time frame: Change from baseline to 3 month
Change from baseline hand grip strength to 3 month, assessed by hand grip dynamometer test.
Time frame: Change from baseline to 3 month
6 secondary outcomes
Change from baseline health related quality of life to 3 month, assessed by perception of health and quality of life five dimension, five levels (EuroQol - EQ-5D-5L) questionnaire.
Time frame: Change from baseline to 3 month
Change from baseline self-management behaviors to 3 month, Use of cognitive symptom management techniques, Communication with Physicians questionnaires.
Time frame: Change from baseline to 3 month
Change from baseline physical activity level to 3 month, assessed by International Physical Activity Questionnaire (IPAQ).
Time frame: Change from baseline to 3 month
Change from baseline gait speed to 3 month, assessed by Six-meters test.
Time frame: Change from baseline to 3 month
Change from baseline balance to 3 month, assessed by Standing Balance test.
Time frame: Change from baseline to 3 month
Change from baseline mobility to 3 month, assessed by Timed "up-and-go" test.
Time frame: Change from baseline to 3 month
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 21 Apr 2016.
- Derived from this study: PubMed 27267755Marconcin P, Espanha M, Yazigi F, Campos P. The PLE(2)NO self-management and exercise program for knee osteoarthritis: Study Protocol for a Randomized Controlled Trial. BMC Musculoskelet Disord. 2016 Jun 7;17:250. doi: 10.1186/s12891-016-1115-7.
- Individual participant dataSharing planned: Yes
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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.
Priscila Marconcin, Master principal investigator
Faculty of Human Kinetics, Lisbon University
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management and exercise and Educational in people with Osteoarthritis, run by Technical University of Lisbon.
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 4 inclusion and 7 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 21 Apr 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.
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?
Change from baseline knee OA symptoms to 3 month, assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. (time frame: Change from baseline to 3 month). The study lists 6 primary outcomes in all. 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 NCT02562833, 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 21 Apr 2016.