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The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02562833
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Priscila Marconcin, Technical University of Lisbon

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Self-Management and exercise Device: Educational Not Applicable

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  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis: A Randomized Controlled Trial
Study Start Date : February 2015
Actual Primary Completion Date : February 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self-Management and exercise Device: 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 Device: 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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Change from baseline functional strength to 3 month, assessed by Five repetition sit to stand test. [ Time Frame: Change from baseline to 3 month ]
  4. Change from baseline cardiorespiratory endurance to 3 month, assessed by Six Minutes' Walk test. [ Time Frame: Change from baseline to 3 month ]
  5. 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 ]
  6. Change from baseline hand grip strength to 3 month, assessed by hand grip dynamometer test. [ Time Frame: Change from baseline to 3 month ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Change from baseline physical activity level to 3 month, assessed by International Physical Activity Questionnaire (IPAQ). [ Time Frame: Change from baseline to 3 month ]
  4. Change from baseline gait speed to 3 month, assessed by Six-meters test. [ Time Frame: Change from baseline to 3 month ]
  5. Change from baseline balance to 3 month, assessed by Standing Balance test. [ Time Frame: Change from baseline to 3 month ]
  6. Change from baseline mobility to 3 month, assessed by Timed "up-and-go" test. [ Time Frame: Change from baseline to 3 month ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age over than or equal to 60 years;
  2. 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);
  3. Independent mobility;
  4. and reading and writing knowledge.

Exclusion Criteria:

  1. Not be involved in another intervention program (exercise, education or physical therapy;
  2. Do not use supplements (chondroitin sulfate and / or glucosamine) for at least three months;
  3. Have other pathology (cardiovascular, respiratory, musculoskeletal, cancer) that prevents physical exercise;
  4. Mental / psychological state hindering understanding of the program;
  5. Having undergone surgery for knee replacement or going perform this surgery in the next eight months;
  6. Being allergic to shellfish;
  7. Have made injections of corticosteroids or hyaluronic acid in the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562833


Sponsors and Collaborators
Technical University of Lisbon
Investigators
Principal Investigator: Priscila Marconcin, Master Faculty of Human Kinetics, Lisbon University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Priscila Marconcin, Master degree, Technical University of Lisbon
ClinicalTrials.gov Identifier: NCT02562833     History of Changes
Other Study ID Numbers: PLENO-FMH-1
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Priscila Marconcin, Technical University of Lisbon:
Osteoarthritis
Self-management
Multi-Component Exercise

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases