Aquatic Exercise Program for Knee Osteoarthritis

NCT ID: NCT01832545

Last Updated: 2013-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-07-31

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.

Conditions

Knee Osteoarthritis; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Educational Program

The communitarian PESO program is based on appropriate clinical guidelines and on validated behavior change principles. Implemented by an intervention team with expertise gained from current scientific research in weight control determinants, this program as well PICO, is free of charge for all interested adults who wish to manage their weight and health. It operates since 2005 with the aims to prevent obesity or reduce excess weight, as well as, some of the risks associated with obesity in adults through a change to steady healthy habits, attitudes and behaviors. PESO has 3 months duration and it is structured in 12 sessions of one and a half hour, once a week.

Group Type: ACTIVE_COMPARATOR

Educational Program

Intervention Type: BEHAVIORAL

Control Group

Aquatic Exetcise

Aquatic Exercise program is organized in 24 sessions distributed over 12 consecutive weeks, with a frequency of twice a week. The duration of each session will be 60 minutes, being that 10 minutes are for patient reception, blood pressure control, pain register or others and the effective time inside the water is 45 minutes. The indoor pool works with an air temperature around 27±1ºC and water temperature is controlled for 30.5±5ºC. Workout is organized in order to have a progressive overload every week or every two sessions, when occurs an introduction of a new stimulus. Water is the main instrument to create resistance and only in the last weeks, according with participants progression and if the self-reported pain controlled, drag equipment will be added.

Group Type: EXPERIMENTAL

Aquatic Exercise

Intervention Type: OTHER

Interventions

Aquatic Exercise

Intervention Type: OTHER

Educational Program

Control Group

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Lisbon

OTHER

Sponsor Role: lead

Responsible Party

Flávia Yázigi

Master Degree in Exercise and Health, PhD student (credits concluded); Professor assistent;

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margarida Espanha, PhD

Role: STUDY_CHAIR

Technical University of Lisbon

Locations

Technical University of Lisbon

Lisbon, Cruz Quebrada-Dafundo, Portugal

Countries

Portugal

References

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.

Reference Type: DERIVED

PMID: 30641533 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24219758 (View on PubMed)

Other Identifiers

PICO-FY013

Identifier Type: -

Identifier Source: org_study_id