Knee OsteoarthritisPICONCT01832545
Aquatic Exercise Program for Knee Osteoarthritis
A study testing Aquatic Exercise and Educational Program in people with Knee Osteoarthritis and Obesity, run by Technical University of Lisbon at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis, Obesity
- What is being tested?
- Aquatic Exercise and Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- Nov 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Technical University of Lisbon
Lisbon, Cruz Quebrada-Dafundo, 1499-002
About this study
Official title: The PICO Project: Aquatic Exercise for Knee Osteoarthritis in Overweight and Obese Individuals
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.
Read the 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
- Being tested
- Aquatic Exercise, Educational Program
- Keywords
- Aquatic exercise, Knee Osteoarthritis, Exercise, Pain, Obesity.
- Medical subject headings
- Osteoarthritis, Knee, Obesity, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic ExerciseOther
Educational ProgramBehavioural
Control Group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Aquatic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: "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
Measured: "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 .
Measured: "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.
Measured: "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).
Measured: "Change" (e.g., "baseline and 12 weeks")
Secondary outcomes (4)
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.
Measured: "Change" (e.g., "baseline and 12 weeks")
Body Morphology
Body Morphology will be registered by anthropometric measurements (body mass, stature, foot length, and waist, hip, mid-thigh and calf circumference).
Measured: "Change" (e.g., "baseline and 12 weeks")
Lifestyle
Lifestyle should be assessed by International Physical Activity Questionnaire (IPAQ)and by the Weight and Lifestyle Inventory (WALI).
Measured: "Change" (e.g., "baseline and 12 weeks")
Inflammatory Markers
The main measures are Interleukin 6 (IL-6),high-sensitivity C-reactive protein (HsCRP), TNFα and TNFα soluble receptor 1(sTNFR1).
Measured: "Change" (e.g., "baseline and 12 weeks")
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flávia Yázigi, Technical University of Lisbon
- Investigators
- Margarida Espanha, PhD, Study chair, Technical University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832545
- Sponsor's protocol ID
- PICO-FY013
- Acronym
- PICO
- Status last verified
- Apr 2013
- First submitted
- 10 Apr 2013
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30641533Yazigi 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.
PubMed 24219758
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PICO Project: Aquatic Exercise for Knee Osteoarthritis in Overweight and Obese Individuals
- ClinicalTrials.gov ID
- NCT01832545
- Acronym / sponsor ID
- PICO / PICO-FY013
- Conditions
- Knee Osteoarthritis, Obesity
- Keywords
- Aquatic exercise, Knee Osteoarthritis, Exercise, Pain, Obesity.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Technical University of LisbonUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Program | Active comparator | Behavioral: Educational ProgramThe 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. |
| Aquatic Exetcise | Experimental | Other: Aquatic ExerciseAquatic 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic Exercise | Other | Aquatic Exetcise |
| Educational ProgramControl Group | Behavioural | Educational Program |
Primary outcome
Knee Osteoarthritis symptoms
Time frame: "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
Time frame: "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
Time frame: "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
Time frame: "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
Time frame: "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).
4 secondary outcomes
Body composition
Time frame: "Change" (e.g., "baseline and 12 weeks")
Body Morphology
Time frame: "Change" (e.g., "baseline and 12 weeks")
Lifestyle
Time frame: "Change" (e.g., "baseline and 12 weeks")
Inflammatory Markers
Time frame: "Change" (e.g., "baseline and 12 weeks")
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
- Derived from this study: PubMed 30641533Yazigi 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.
- Derived from this study: PubMed 24219758Yazigi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarida Espanha, PhD study chair
Technical University of Lisbon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Exercise and Educational Program in people with Knee Osteoarthritis and Obesity, run by Technical University of Lisbon at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Osteoarthritis symptoms (time frame: "Change" (e.g., "baseline and 12 weeks")). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01832545, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2013.