Aquatic Exercise Program for Knee Osteoarthritis

Study Overview
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Brief Summary
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The aim of PICO study is to design an aquatic exercise program specific for obese individuals with knee osteoarthritis which the main goals are OA symptoms management and the improvement of physical fitness. The author's opinion is that the musculoskeletal pain is the main constraint for any kind of mobility and its control should be considered as an important goal in the weight management's programs. Therefore the PICO project proposes an aquatic exercise program to controlling pain and other symptoms management, showing that it is possible to live with the disease, and motivating the change in lifestyle, thus preventing the installation or worsening of KOA. In this way, five hypotheses were formulated: H1. 3 months of aquatic exercise is enough to improve KOA symptoms and functionality in obese individuals; H2. The gait parameters of obese individuals with KOA can be improved by aquatic exercise; H3. Beyond the exercises skills, aquatic exercise group classes can work with an educational component, promoting lifestyles changes. H4: Pain reduction and a better psychological status can lead an increase of functionally, increasing amount of physical activity. H5: Even if the main goal is not weight management, the aquatic exercise program can lead a weight reduction or body composition change.

Detailed Description
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The PICO program is an overall body fitness and mind intervention through aquatic exercise involving as well an education component, created specifically for individuals with KOA. Its a single-blinded, one center, and randomized controlled trial with 3 months duration. Participants will be randomized into one of two groups: aquatic exercise (AE) and control group (CG) which will participate in an educational program with the same hourly load.

Official Title
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The PICO Project: Aquatic Exercise for Knee Osteoarthritis in Overweight and Obese Individuals

Conditions
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Knee Osteoarthritis, Obesity

Intervention / Treatment
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* Other: Aquatic Exercise
* Behavioral: Educational Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study sample will consist of 60 adults, community-dwelling (Lisbon) people with: (1) age 40-65 years; (2) 28.0 ≤ BMI ≤ 45 kg/m2; unilateral or bilateral KOA (3) knee pain (4) grade I-III radiographic tibiofemoral OA or tibiofemoral plus patellofemoral OA (5) a sedentary lifestyle, defined as not participating in a program that incorporates more than 30 minutes per week of formal exercise within the past 6 months; (6) being independent with mobility capacity; and (7) reading and writing knowledge. Exclusion Criteria: Subjects with skin diseases, unstable medical conditions and with hip or knee replacement, knee surgery within the past 6 months and participants who had any type of knee injections within the past 3 months will be excluded of PICO.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Educational Program<br>The communitarian PESO program is based on appropriate clinical guidelines and on validated behavior change principles. Implemented by an intervention team with expertise gained from current scientific research in weight control determinants, this program as well PICO, is free of charge for all interested adults who wish to manage their weight and health. It operates since 2005 with the aims to prevent obesity or reduce excess weight, as well as, some of the risks associated with obesity in adults through a change to steady healthy habits, attitudes and behaviors. PESO has 3 months duration and it is structured in 12 sessions of one and a half hour, once a week. | Behavioral: Educational Program<br>* Control Group<br>|
| Experimental: Aquatic Exetcise<br>Aquatic Exercise program is organized in 24 sessions distributed over 12 consecutive weeks, with a frequency of twice a week. The duration of each session will be 60 minutes, being that 10 minutes are for patient reception, blood pressure control, pain register or others and the effective time inside the water is 45 minutes. The indoor pool works with an air temperature around 27±1ºC and water temperature is controlled for 30.5±5ºC. Workout is organized in order to have a progressive overload every week or every two sessions, when occurs an introduction of a new stimulus. Water is the main instrument to create resistance and only in the last weeks, according with participants progression and if the self-reported pain controlled, drag equipment will be added. | Other: Aquatic Exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Osteoarthritis symptoms | Pain, stiffness and other symptoms should be assessed by the Brief Pain Inventory (BPI); Numerical Rating Scale (NRS) and by the Knee Injury and arthritis Outcome Score (KOOS) | Change (e.g., baseline and 12 weeks) | 
| Health Quality of Life | The MOS Short-Form Health Survey (SF-12)and the Beck Depression Inventory (BDI-II) will be used to asses Quality of life and Psychological status | Change (e.g., baseline and 12 weeks) | 
| Physical Function | Physical function will be assessed by the following functional tests: The Six Minutes Walking Test to verify aerobic capacity and the walking ability; The Chair Sit and Reach test for hamstring flexibility; The Back Scratch Test for overall shoulder range of motion; The Five-Repetition Sit-To-Stand Test for functional strength . | Change (e.g., baseline and 12 weeks) | 
| Strength | A dynamometer will be used for isokinetic assessment of knee strength (flexor and extensor muscles) and isometric knee strength, bilaterally; The Handgrip Strength Test will evaluate maximal isometric force of the muscles of the hand and forearm. | Change (e.g., baseline and 12 weeks) | 
| Gait | Kinematics and kinetics outcomes will be analyzed from gait test (gait speed, gait cycle, ground reaction forces and knee forces moments). | Change (e.g., baseline and 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Body composition. Body Mass Index and a dual energy x-ray absorptiometry (DXA) scanner will be used to measure whole body lean mass, fat mass and bone mineral content. | Change (e.g., baseline and 12 weeks) | 
| Body Morphology | Body Morphology will be registered by anthropometric measurements (body mass, stature, foot length, and waist, hip, mid-thigh and calf circumference). | Change (e.g., baseline and 12 weeks) | 
| Lifestyle | Lifestyle should be assessed by International Physical Activity Questionnaire (IPAQ)and by the Weight and Lifestyle Inventory (WALI). | Change (e.g., baseline and 12 weeks) | 
| Inflammatory Markers | The main measures are Interleukin 6 (IL-6),high-sensitivity C-reactive protein (HsCRP), TNFα and TNFα soluble receptor 1(sTNFR1). | Change (e.g., baseline and 12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Aquatic exercise, Knee Osteoarthritis, Obesity., Pain