Different Modalities of Aquatic Physiotherapy in Patients With Knee Osteoarthrosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Other: Low impact immersion; Other: Conventional aquatic physiotherapy; Other: High intensity aquatic physiotherapy

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernanda Cechetti; Phone Number: 3303-8700; Email: nandacecheti@gmail.com
• Study Contact Backup: Name: A Teixeria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low impact immersion; This intervention will use the principles of Ai Chi, a model defined as a low-intensity aquatic exercise strategy	Other: Low impact immersion; 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.
Experimental: Conventional aquatic physiotherapy; In this intervention, medium impact exercises will be performed, with a comfortable movement speed.	Other: Conventional aquatic physiotherapy; 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.
Experimental: High intensity aquatic physiotherapy; In this intervention, high-impact exercises will be performed, with maximum movement speed, twice time of the medium-intensity protocol	Other: High intensity aquatic physiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions in mg/mL

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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.	Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre

Study record dates

Study Major Dates

• Study Start (Anticipated): March 30, 2023
• Primary Completion (Anticipated): December 3, 2023
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Hydrotherapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: FUHSPortoAlegreCesar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No