Skip to main content
OpenTrials
Completed

NCT Number: NCT02562833

The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Management and exercise

Device

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.

Educational

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Technical University of Lisbon

Other

Registry information

Official study title

The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 29, 2015
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.