- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02562833
The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis
April 20, 2016 updated by: Priscila Marconcin, Technical University of Lisbon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self-Management and exercise
|
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.
|
Active Comparator: Educational
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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 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 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 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 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 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
|
Change from baseline to 3 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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 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 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 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 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 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
|
Change from baseline to 3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Priscila Marconcin, Master, Faculty of Human Kinetics, Lisbon University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
September 23, 2015
First Submitted That Met QC Criteria
September 25, 2015
First Posted (Estimate)
September 29, 2015
Study Record Updates
Last Update Posted (Estimate)
April 21, 2016
Last Update Submitted That Met QC Criteria
April 20, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLENO-FMH-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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