Clinical trial NCT01832545: Aquatic Exercise Program for Knee Osteoarthritis
Official title: The PICO Project: Aquatic Exercise for Knee Osteoarthritis in Overweight and Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Obesity
Keywords: Aquatic exercise
Knee Osteoarthritis
Exercise
Pain
Obesity.
Lead sponsor: Technical University of Lisbon
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knee Osteoarthritis symptoms
timeFrame: "Change" (e.g., "baseline and 12 weeks")
measure: Health Quality of Life
timeFrame: "Change" (e.g., "baseline and 12 weeks")
measure: Physical Function
timeFrame: "Change" (e.g., "baseline and 12 weeks")
measure: Strength
timeFrame: "Change" (e.g., "baseline and 12 weeks")
measure: Gait
timeFrame: "Change" (e.g., "baseline and 12 weeks")
Secondary outcomes:
measure: Body composition
timeFrame: "Change" (e.g., "baseline and 12 weeks")
measure: Body Morphology
timeFrame: "Change" (e.g., "baseline and 12 weeks")
measure: Lifestyle
timeFrame: "Change" (e.g., "baseline and 12 weeks")
measure: Inflammatory Markers
timeFrame: "Change" (e.g., "baseline and 12 weeks")
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Technical University of Lisbon
state: Cruz Quebrada-Dafundo
Study officials:
affiliation: Technical University of Lisbon
name: Margarida Espanha, PhD
role: STUDY_CHAIR
References:
citation: Yazigi F, Espanha M, Marques A, Teles J, Teixeira P. Predictors of walking capacity in obese adults with knee osteoarthritis. Acta Reumatol Port. 2018 Oct-Dec;43(4):256-263.
citation: Yazigi F, Espanha M, Vieira F, Messier SP, Monteiro C, Veloso AP. The PICO project: aquatic exercise for knee osteoarthritis in overweight and obese individuals. BMC Musculoskelet Disord. 2013 Nov 13;14:320. doi: 10.1186/1471-2474-14-320.