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The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-Management and exercise
Educational
Sponsored by
Technical University of Lisbon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Self-management, Multi-Component Exercise

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Self-Management and exercise

    Educational

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change from baseline knee OA symptoms to 3 month, assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire.
    Change from baseline self-efficacy to 3 month, assessed by Self-efficacy for managing Chronic Disease - 6-Item Scale questionnaire.
    Change from baseline functional strength to 3 month, assessed by Five repetition sit to stand test.
    Change from baseline cardiorespiratory endurance to 3 month, assessed by Six Minutes' Walk test.
    Change from baseline flexibility to 3 month, assessed by Chair Sit and Reach test, and the Back Scratch test.
    Change from baseline hand grip strength to 3 month, assessed by hand grip dynamometer test.

    Secondary Outcome Measures

    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.
    Change from baseline self-management behaviors to 3 month, Use of cognitive symptom management techniques, Communication with Physicians questionnaires.
    Change from baseline physical activity level to 3 month, assessed by International Physical Activity Questionnaire (IPAQ).
    Change from baseline gait speed to 3 month, assessed by Six-meters test.
    Change from baseline balance to 3 month, assessed by Standing Balance test.
    Change from baseline mobility to 3 month, assessed by Timed "up-and-go" test.

    Full Information

    First Posted
    September 23, 2015
    Last Updated
    April 20, 2016
    Sponsor
    Technical University of Lisbon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02562833
    Brief Title
    The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis
    Official Title
    The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Technical University of Lisbon

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis
    Keywords
    Osteoarthritis, Self-management, Multi-Component Exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Self-Management and exercise
    Arm Type
    Experimental
    Arm Title
    Educational
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Self-Management and exercise
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Educational
    Intervention Description
    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 Measure Information:
    Title
    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
    Title
    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
    Title
    Change from baseline functional strength to 3 month, assessed by Five repetition sit to stand test.
    Time Frame
    Change from baseline to 3 month
    Title
    Change from baseline cardiorespiratory endurance to 3 month, assessed by Six Minutes' Walk test.
    Time Frame
    Change from baseline to 3 month
    Title
    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
    Title
    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 Measure Information:
    Title
    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
    Title
    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
    Title
    Change from baseline physical activity level to 3 month, assessed by International Physical Activity Questionnaire (IPAQ).
    Time Frame
    Change from baseline to 3 month
    Title
    Change from baseline gait speed to 3 month, assessed by Six-meters test.
    Time Frame
    Change from baseline to 3 month
    Title
    Change from baseline balance to 3 month, assessed by Standing Balance test.
    Time Frame
    Change from baseline to 3 month
    Title
    Change from baseline mobility to 3 month, assessed by Timed "up-and-go" test.
    Time Frame
    Change from baseline to 3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Priscila Marconcin, Master
    Organizational Affiliation
    Faculty of Human Kinetics, Lisbon University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    27267755
    Citation
    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.
    Results Reference
    derived

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    The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis

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