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Different Modalities of Aquatic Physiotherapy in Patients With Knee Osteoarthrosis

Primary Purpose

Osteoarthritis of the Knee

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low impact immersion
Conventional aquatic physiotherapy
High intensity aquatic physiotherapy
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Hydrotherapy

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Inflammatory, rheumatic or autoimmune conditions Use of psychotropic, immunosuppressive and steroid medications Antioxidant consumption Alcohol and tobacco consumption Progressive ankylosis states neurological injuries 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Low impact immersion

    Conventional aquatic physiotherapy

    High intensity aquatic physiotherapy

    Arm Description

    This intervention will use the principles of Ai Chi, a model defined as a low-intensity aquatic exercise strategy

    In this intervention, medium impact exercises will be performed, with a comfortable movement speed.

    In this intervention, high-impact exercises will be performed, with maximum movement speed, twice time of the medium-intensity protocol

    Outcomes

    Primary Outcome Measures

    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
    Biochemical variables over time
    Variations in the concentration of Metalloproetinase

    Secondary Outcome Measures

    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.
    Edema over time
    Performed based on the measurement of the circumference of the affected knee. Result expressed in centimeters
    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
    Muscle strength over time
    Measured by dynamometer to assess knee extension strength. Results expressed in kg of force.

    Full Information

    First Posted
    January 20, 2022
    Last Updated
    January 18, 2023
    Sponsor
    Federal University of Health Science of Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05610696
    Brief Title
    Different Modalities of Aquatic Physiotherapy in Patients With Knee Osteoarthrosis
    Official Title
    Effects of Different Modalities of Aquatic Physiotherapy on Biomechanical and Functional Behavior of Subjects With Knee Osteoarthrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 30, 2023 (Anticipated)
    Primary Completion Date
    December 3, 2023 (Anticipated)
    Study Completion Date
    January 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Health Science of Porto Alegre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis of the Knee
    Keywords
    Osteoarthritis, Hydrotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Randomized clinical trial, of the crossover type
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low impact immersion
    Arm Type
    Experimental
    Arm Description
    This intervention will use the principles of Ai Chi, a model defined as a low-intensity aquatic exercise strategy
    Arm Title
    Conventional aquatic physiotherapy
    Arm Type
    Experimental
    Arm Description
    In this intervention, medium impact exercises will be performed, with a comfortable movement speed.
    Arm Title
    High intensity aquatic physiotherapy
    Arm Type
    Experimental
    Arm Description
    In this intervention, high-impact exercises will be performed, with maximum movement speed, twice time of the medium-intensity protocol
    Intervention Type
    Other
    Intervention Name(s)
    Low impact immersion
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional aquatic physiotherapy
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    High intensity aquatic physiotherapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Biochemical variables over time
    Description
    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
    Time Frame
    Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions
    Title
    Biochemical variables over time
    Description
    Variations in the concentration of Metalloproetinase
    Time Frame
    Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions in mg/mL
    Secondary Outcome Measure Information:
    Title
    Degree of pain over time
    Description
    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.
    Time Frame
    Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.
    Title
    Edema over time
    Description
    Performed based on the measurement of the circumference of the affected knee. Result expressed in centimeters
    Time Frame
    Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention)
    Title
    Flexibility over time
    Description
    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
    Time Frame
    Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.
    Title
    Muscle strength over time
    Description
    Measured by dynamometer to assess knee extension strength. Results expressed in kg of force.
    Time Frame
    Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Inflammatory, rheumatic or autoimmune conditions Use of psychotropic, immunosuppressive and steroid medications Antioxidant consumption Alcohol and tobacco consumption Progressive ankylosis states neurological injuries 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fernanda Cechetti
    Phone
    3303-8700
    Email
    nandacecheti@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    A Teixeria

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Different Modalities of Aquatic Physiotherapy in Patients With Knee Osteoarthrosis

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