Aquatic Exercise Program for Knee Osteoarthritis

Obesity Clinical Trial

— PICO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832545
• Other study ID #: PICO-FY013
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: April 15, 2013
• Start date: November 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2013
• Source: Technical University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Obesity
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Aquatic Exercise

Behavioral:
• Educational Program
Control Group

Locations

Country	Name	City	State
Portugal	Technical University of Lisbon	Lisbon	Cruz Quebrada-Dafundo

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Lisbon

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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")	Yes
Primary	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")	Yes
Primary	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")	Yes
Primary	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")	Yes
Primary	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")	Yes
Secondary	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")	Yes
Secondary	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")	Yes
Secondary	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")	Yes
Secondary	Inflammatory Markers	The main measures are Interleukin 6 (IL-6),high-sensitivity C-reactive protein (HsCRP), TNFa and TNFa soluble receptor 1(sTNFR1).	"Change" (e.g., "baseline and 12 weeks")	Yes