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Completed

NCT Number: NCT01832545

Aquatic Exercise Program for Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Behavior Body Weight Joint Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoarthritis Osteoarthritis, Knee Overnutrition Overweight Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technical University of Lisbon

Lisbon, Cruz Quebrada-Dafundo, 1499-002, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aquatic Exercise

Other

educational program

Behavioral

Control Group

Primary outcomes

  1. Knee Osteoarthritis symptoms

    Time frame: "Change" (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)

  2. Health Quality of Life

    Time frame: "Change" (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

  3. Physical Function

    Time frame: "Change" (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 .

  4. Strength

    Time frame: "Change" (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.

  5. Gait

    Time frame: "Change" (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).

Secondary outcomes

  1. Body composition

    Time frame: "Change" (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.

  2. Body Morphology

    Time frame: "Change" (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).

  3. Lifestyle

    Time frame: "Change" (e.g., "baseline and 12 weeks")

    Lifestyle should be assessed by International Physical Activity Questionnaire (IPAQ)and by the Weight and Lifestyle Inventory (WALI).

  4. Inflammatory Markers

    Time frame: "Change" (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).

Sponsors and collaborators

Lead sponsor

Technical University of Lisbon

Other

Registry information

Official study title

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

Acronym: PICO

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 16, 2013
Registry last updated
Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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