The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis

NCT ID: NCT02562833

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-10-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self-Management and exercise

Group Type: EXPERIMENTAL

Self-Management and exercise

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Educational

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technical University of Lisbon

OTHER

Sponsor Role: lead

Responsible Party

Priscila Marconcin

Master degree

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Priscila Marconcin, Master

Role: PRINCIPAL_INVESTIGATOR

Faculty of Human Kinetics, Lisbon University

References

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.

Reference Type: DERIVED

PMID: 27267755 (View on PubMed)

Other Identifiers

PLENO-FMH-1

Identifier Type: -

Identifier Source: org_study_id