Osteoarthritis of the KneeNCT05610696
Different Modalities of Aquatic Physiotherapy in Patients With Knee Osteoarthrosis
A study testing Low impact immersion, Conventional aquatic physiotherapy and High intensity aquatic physiotherapy in people with Osteoarthritis of the Knee, run by Federal University of Health Science of Porto Alegre.
Trial summary
The aim of this study is to evaluate the effects of different modalities of aquatic physiotherapy on the biochemical and functional behavior of patients with knee's Osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Low impact immersion, Conventional aquatic physiotherapy and High intensity aquatic physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2023to 31 Jan 2024
- 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 50 years old and diagnosed with OA in at least one knee
- Presence of pain and at least one functional dysfunction for at least 6 months
- Absence of physical limitation that prevents the exercise protocol from being performed
- Kellgren and Lawrence ranking between I and IV
- walk independently and without auxiliary device
Who cannot join
- Inflammatory, rheumatic or autoimmune conditions
- Use of psychotropic, immunosuppressive and steroid medications
- Antioxidant consumption
- Alcohol and tobacco consumption
- Progressive ankylosis states
- neurological injuries
Show all 11Show fewer
- Infections or skin diseases that contraindicate swimming pool immersion
- Surgical procedures on the knee joint in the last 12 months (excluding meniscectomy or arthroscopy)
- Lower Limb Joint Prosthesis
- Presence of inflammatory or infectious diseases, uncontrolled systemic arterial hypertension, uncontrolled diabetes, chronic obstructive pulmonary disease and history of ischemic heart disease
- Self-report of aquatic phobia and chlorine allergies
Trial locations and contacts
No sites are listed yet.
A Teixeria contact
About this study
Official title: Effects of Different Modalities of Aquatic Physiotherapy on Biomechanical and Functional Behavior of Subjects With Knee Osteoarthrosis
The aim of this study is to evaluate the effects of different modalities of aquatic physiotherapy on the biochemical and functional behavior of patients with knee's Osteoarthritis.
Read the detailed description
The subjects will be informed about the study and its potentials risks and sign the informed consent. The sample will be submitted to three different modalities of AF interventions: (a) low impact immersion, (b) conventional aquatic physiotherapy and (c) high intensity aquatic physiotherapy. The functional variables of flexibility, pain, joint volume will be evaluated before and immediately after each intervention whereas the biochemical variables will be evaluated from the analysis of peripheral blood following times: baseline moment (immediately before the intervention), moment 1 (immediately after the intervention), and moment 2 (24 hours after the intervention).
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Low impact immersion, Conventional aquatic physiotherapy, High intensity aquatic physiotherapy
- Keywords
- Osteoarthritis, Hydrotherapy
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low impact immersionOther
Consists of a sequence of shoulder, trunk and hip movements. In this modality, the aim will be to understand the physiological effects of immersion in heat water. Resisted movements (either by turbulence or by floats) or interventional maneuvers in the knee joints will not be performed. Considering the period of 5 minutes for acclimatization to the liquid environment, the program will last approximately 47 minutes.
Conventional aquatic physiotherapyOther
include warm-up, strengthening and calming down activities. Aquatic steppes will be used to ensure that all participants will maintain the waterline level approximately in the xiphoid appendix. For strengthening activities, the exercises must be performed at an adequate speed, which ensures a comfortable level for the activity. For this purpose, a subjective feedback will be extracted from the participants constantly. The warm-up sequence consists of six different active hip and knee movements performed at maximum range of motion and contributes to neuromuscular activation. For strengthening, each movement should be performed for 1 minute (30 seconds for each lower limb) followed by a period of 30 seconds of rest between each movement.
High intensity aquatic physiotherapyOther
In this modality subjects will perform the same sequence of exercises of the Conventional Aquatic Physiotherapy program will be respected. However the work load and speed will be adjusted to the maximum level. For strengthening, each movement should be performed for 2 minutes (1 minute for each lower limb) followed by a period of 30 seconds of rest between each movement. To guarantee the maximum effort of the participants, verbal stimuli will be constantly provided. The program will last approximately 68 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Low impact immersion | Experimental | This intervention will use the principles of Ai Chi, a model defined as a low-intensity aquatic exercise strategy Receives: Other: Low impact immersion |
| Conventional aquatic physiotherapy | Experimental | In this intervention, medium impact exercises will be performed, with a comfortable movement speed. Receives: Other: Conventional aquatic physiotherapy |
| High intensity aquatic physiotherapy | Experimental | In this intervention, high-impact exercises will be performed, with maximum movement speed, twice time of the medium-intensity protocol Receives: Other: High intensity aquatic physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical variables over time
Variations in the concentration of and Glutathione perioxidase in peripheral blood resulting from three aquatic physical therapy interventions evaluated comparatively between the different interventions in U/L
Measured: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions
Biochemical variables over time
Variations in the concentration of Metalloproetinase
Measured: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions in mg/mL
Secondary outcomes (4)
Degree of pain over time
Performed using the visual analogue pain scale, from a scale graduated from zero to 10, in which zero corresponds to cases without pain and 10 corresponds to the worst imaginable pain.
Measured: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.
Edema over time
Performed based on the measurement of the circumference of the affected knee. Result expressed in centimeters
Measured: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention)
Flexibility over time
Assessed by measuring the amplitude of the active and passive movement for the knee flexion and, for that, a conventional goniometer will be used. Result expressed in degrees
Measured: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.
Muscle strength over time
Measured by dynamometer to assess knee extension strength. Results expressed in kg of force.
Measured: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start30 Mar 2023 (estimated)
- Primary completion3 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies 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
- Crossover
- Model description
- Randomized clinical trial, of the crossover type
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Cechetti, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610696
- Sponsor's protocol ID
- FUHSPortoAlegreCesar
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Augusto Teixeira C, Haas L, Frata B, Fiori Bortoli A, Scalco Acco F, de Castro G, Cechetti F. Effects of a low, medium, and high-intensity aquatic physiotherapy protocol on functional and biochemical parameters in individuals with knee osteoarthritis: protocol for a crossover randomized controlled trial. F1000Res. 2024 Sep 16;12:1605. doi: 10.12688/f1000research.140342.4. eCollection 2023.
PubMed 39296351
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Modalities of Aquatic Physiotherapy on Biomechanical and Functional Behavior of Subjects With Knee Osteoarthrosis
- ClinicalTrials.gov ID
- NCT05610696
- Acronym / sponsor ID
- FUHSPortoAlegreCesar
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, Hydrotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 3 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 9 Nov 2022 (actual)
- 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 this study is to evaluate the effects of different modalities of aquatic physiotherapy on the biochemical and functional behavior of patients with knee's Osteoarthritis.
Detailed description
The subjects will be informed about the study and its potentials risks and sign the informed consent. The sample will be submitted to three different modalities of AF interventions: (a) low impact immersion, (b) conventional aquatic physiotherapy and (c) high intensity aquatic physiotherapy. The functional variables of flexibility, pain, joint volume will be evaluated before and immediately after each intervention whereas the biochemical variables will be evaluated from the analysis of peripheral blood following times: baseline moment (immediately before the intervention), moment 1 (immediately after the intervention), and moment 2 (24 hours after the intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized clinical trial, of the crossover type
| Arm | Type | Receives |
|---|---|---|
| Low impact immersion | Experimental | Other: Low impact immersionThis intervention will use the principles of Ai Chi, a model defined as a low-intensity aquatic exercise strategy |
| Conventional aquatic physiotherapy | Experimental | Other: Conventional aquatic physiotherapyIn this intervention, medium impact exercises will be performed, with a comfortable movement speed. |
| High intensity aquatic physiotherapy | Experimental | Other: High intensity aquatic physiotherapyIn this intervention, high-impact exercises will be performed, with maximum movement speed, twice time of the medium-intensity protocol |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 50 years old and diagnosed with OA in at least one knee
- Presence of pain and at least one functional dysfunction for at least 6 months
- Absence of physical limitation that prevents the exercise protocol from being performed
- Kellgren and Lawrence ranking between I and IV
- walk independently and without auxiliary device
Key exclusion criteria (11 listed)
- Inflammatory, rheumatic or autoimmune conditions
- Use of psychotropic, immunosuppressive and steroid medications
- Antioxidant consumption
- Alcohol and tobacco consumption
- Progressive ankylosis states
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 |
|---|---|---|
| Low impact immersionConsists of a sequence of shoulder, trunk and hip movements. In this modality, the aim will be to understand the physiological effects of immersion in heat water. Resisted movements (either by turbulence or by floats) or interventional maneuvers in the knee joints will not be performed. Considering the period of 5 minutes for acclimatization to the liquid environment, the program will last approximately 47 minutes. | Other | Low impact immersion |
| Conventional aquatic physiotherapyinclude warm-up, strengthening and calming down activities. Aquatic steppes will be used to ensure that all participants will maintain the waterline level approximately in the xiphoid appendix. For strengthening activities, the exercises must be performed at an adequate speed, which ensures a comfortable level for the activity. For this purpose, a subjective feedback will be extracted from the participants constantly. The warm-up sequence consists of six different active hip and knee movements performed at maximum range of motion and contributes to neuromuscular activation. For strengthening, each movement should be performed for 1 minute (30 seconds for each lower limb) followed by a period of 30 seconds of rest between each movement. | Other | Conventional aquatic physiotherapy |
| High intensity aquatic physiotherapyIn this modality subjects will perform the same sequence of exercises of the Conventional Aquatic Physiotherapy program will be respected. However the work load and speed will be adjusted to the maximum level. For strengthening, each movement should be performed for 2 minutes (1 minute for each lower limb) followed by a period of 30 seconds of rest between each movement. To guarantee the maximum effort of the participants, verbal stimuli will be constantly provided. The program will last approximately 68 minutes. | Other | High intensity aquatic physiotherapy |
Primary outcome
Biochemical variables over time
Time frame: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions
Variations in the concentration of and Glutathione perioxidase in peripheral blood resulting from three aquatic physical therapy interventions evaluated comparatively between the different interventions in U/L
Biochemical variables over time
Time frame: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions in mg/mL
Variations in the concentration of Metalloproetinase
4 secondary outcomes
Degree of pain over time
Time frame: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.
Edema over time
Time frame: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention)
Flexibility over time
Time frame: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.
Muscle strength over time
Time frame: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Derived from this study: PubMed 39296351Augusto Teixeira C, Haas L, Frata B, Fiori Bortoli A, Scalco Acco F, de Castro G, Cechetti F. Effects of a low, medium, and high-intensity aquatic physiotherapy protocol on functional and biochemical parameters in individuals with knee osteoarthritis: protocol for a crossover randomized controlled trial. F1000Res. 2024 Sep 16;12:1605. doi: 10.12688/f1000research.140342.4. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
A Teixeria contact
Questions about this trial
What is this clinical trial studying?
A study testing Low impact immersion, Conventional aquatic physiotherapy and High intensity aquatic physiotherapy in people with Osteoarthritis of the Knee, run by Federal University of Health Science of Porto Alegre.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda Cechetti (3303-8700, nandacecheti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical variables over time (time frame: Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions). The study lists 2 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 NCT05610696, which also lists 1 linked publication.
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 20 Jan 2023.