Aquatic Exercise Program for Knee Osteoarthritis

NCT01832545 | Completed

• 1 other identifier: PICO-FY013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Obesity

Keywords

Aquatic exercise; Knee Osteoarthritis; Exercise; Pain; Obesity.

Outcome Measures

Primary Outcomes (5)

• 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")

• 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")

• 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")

• 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")

• 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")

Secondary Outcomes (4)

• 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")

Study Arms (2)

Educational Program

ACTIVE COMPARATOR

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.

Behavioral: Educational Program

Aquatic Exetcise

EXPERIMENTAL

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.

Other: Aquatic Exercise

Interventions

Aquatic Exercise OTHER

Aquatic Exetcise

Educational Program BEHAVIORAL

Control Group

Educational Program

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technical University of Lisbon: lead

Study Sites (1)

Technical University of Lisbon

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

Location

Related Publications (2)

• 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.

  PMID: 30641533 DERIVED

• 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.

  PMID: 24219758 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Obesity; Motor Activity; Pain

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Margarida Espanha, PhD

  Technical University of Lisbon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree in Exercise and Health, PhD student (credits concluded); Professor assistent;

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 16, 2013
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 16, 2013

Record last verified: 2013-04

Locations

PT (1)