The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis

Technical University of Lisbon

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: Self-Management and exercise; Device: Educational

Study type: Interventional

Funder types: Other

Identifiers

NCT02562833

PLENO-FMH-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Self-Management and exercise

Experimental group

Treatment:

Device: Self-Management and exercise

Educational

Active Comparator group

Treatment:

Device: Educational