Different Modalities of Aquatic Physiotherapy in Patients With Knee Osteoarthrosis

Sponsor

Federal University of Health Science of Porto Alegre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05610696

Collaborator

(none)

Enrollment

Arms

10.1

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Knee	Other: Low impact immersion Other: Conventional aquatic physiotherapy Other: High intensity aquatic physiotherapy	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized clinical trial, of the crossover typeRandomized clinical trial, of the crossover type

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Different Modalities of Aquatic Physiotherapy on Biomechanical and Functional Behavior of Subjects With Knee Osteoarthrosis

Anticipated Study Start Date :

Mar 30, 2023

Anticipated Primary Completion Date :

Dec 3, 2023

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Biochemical variables over time [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 [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

Secondary Outcome Measures

Degree of pain over time [Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.]
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 [Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention)]
Performed based on the measurement of the circumference of the affected knee. Result expressed in centimeters
Flexibility over time [Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.]
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 [Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.]
Measured by dynamometer to assess knee extension strength. Results expressed in kg of force.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 95 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Federal University of Health Science of Porto Alegre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fernanda Cechetti, Sponsor-Investigator, Federal University of Health Science of Porto Alegre

ClinicalTrials.gov Identifier:

NCT05610696

Other Study ID Numbers:

FUHSPortoAlegreCesar

First Posted:

Nov 9, 2022

Last Update Posted:

Jan 20, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fernanda Cechetti, Sponsor-Investigator, Federal University of Health Science of Porto Alegre

Osteoarthritis

Hydrotherapy

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Jan 20, 2023