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
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Self-management, Multi-Component Exercise
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
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
NCT ID
NCT02562833
First Posted
September 23, 2015
Last Updated
April 20, 2016
Sponsor
Technical University of Lisbon
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
Learn more about this trial
The PLE²NO Self-management and Exercise Program for Knee Osteoarthritis
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