The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis

NCT02562833 | Completed

• 1 other identifier: PLENO-FMH-1
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Self-management; Multi-Component Exercise

Outcome Measures

Primary Outcomes (6)

• Change from baseline knee OA symptoms to 3 month, assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire.

  Change from baseline to 3 month

• Change from baseline self-efficacy to 3 month, assessed by Self-efficacy for managing Chronic Disease - 6-Item Scale questionnaire.

  Change from baseline to 3 month

• Change from baseline functional strength to 3 month, assessed by Five repetition sit to stand test.

  Change from baseline to 3 month

• Change from baseline cardiorespiratory endurance to 3 month, assessed by Six Minutes' Walk test.

  Change from baseline to 3 month

• Change from baseline flexibility to 3 month, assessed by Chair Sit and Reach test, and the Back Scratch test.

  Change from baseline to 3 month

• Change from baseline hand grip strength to 3 month, assessed by hand grip dynamometer test.

  Change from baseline to 3 month

Secondary Outcomes (6)

• 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 to 3 month

• Change from baseline self-management behaviors to 3 month, Use of cognitive symptom management techniques, Communication with Physicians questionnaires.

  Change from baseline to 3 month

• Change from baseline physical activity level to 3 month, assessed by International Physical Activity Questionnaire (IPAQ).

  Change from baseline to 3 month

• Change from baseline gait speed to 3 month, assessed by Six-meters test.

  Change from baseline to 3 month

• Change from baseline balance to 3 month, assessed by Standing Balance test.

  Change from baseline to 3 month

Study Arms (2)

Self-Management and exercise

EXPERIMENTAL

Device: Self-Management and exercise

Educational

ACTIVE COMPARATOR

Device: Educational

Interventions

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.

Self-Management and exercise

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.

Educational

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Lisbon: lead

Related Publications (1)

• 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.

  PMID: 27267755 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Exercise Therapy; Models, Educational

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Models, Theoretical; Investigative Techniques

Study Officials

• Priscila Marconcin, Master

  Faculty of Human Kinetics, Lisbon University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 29, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share