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Aquatic Exercise Program for Knee Osteoarthritis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01832545
Acronym
PICO
Enrollment
50
Registered
2013-04-16
Start date
2011-11-30
Completion date
2012-07-31
Last updated
2013-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis, Obesity

Keywords

Aquatic exercise, Knee Osteoarthritis, Exercise, Pain, Obesity.

Brief summary

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

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.

Interventions

BEHAVIORALEducational Program

Control Group

Sponsors

Technical University of Lisbon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
GaitChange (e.g., baseline and 12 weeks)Kinematics and kinetics outcomes will be analyzed from gait test (gait speed, gait cycle, ground reaction forces and knee forces moments).
Knee Osteoarthritis symptomsChange (e.g., baseline and 12 weeks)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)
Health Quality of LifeChange (e.g., baseline and 12 weeks)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
Physical FunctionChange (e.g., baseline and 12 weeks)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 .
StrengthChange (e.g., baseline and 12 weeks)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.

Secondary

MeasureTime frameDescription
Body MorphologyChange (e.g., baseline and 12 weeks)Body Morphology will be registered by anthropometric measurements (body mass, stature, foot length, and waist, hip, mid-thigh and calf circumference).
LifestyleChange (e.g., baseline and 12 weeks)Lifestyle should be assessed by International Physical Activity Questionnaire (IPAQ)and by the Weight and Lifestyle Inventory (WALI).
Inflammatory MarkersChange (e.g., baseline and 12 weeks)The main measures are Interleukin 6 (IL-6),high-sensitivity C-reactive protein (HsCRP), TNFα and TNFα soluble receptor 1(sTNFR1).
Body compositionChange (e.g., baseline and 12 weeks)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.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026