The PICO Project: Aquatic Exercise for Knee Osteoarthritis in Overweight and Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Knee Osteoarthritis symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Knee Osteoarthritis symptoms
时间窗: "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)
Health Quality of Life
时间窗: "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
Physical Function
时间窗: "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 .
Strength
时间窗: "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.
Gait
时间窗: "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).
次要结局
- Body composition("Change" (e.g., "baseline and 12 weeks"))
- Body Morphology("Change" (e.g., "baseline and 12 weeks"))
- Lifestyle("Change" (e.g., "baseline and 12 weeks"))
- Inflammatory Markers("Change" (e.g., "baseline and 12 weeks"))
研究者
Flávia Yázigi
Master Degree in Exercise and Health, PhD student (credits concluded); Professor assistent;
Technical University of Lisbon