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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05610696
Other study ID # FUHSPortoAlegreCesar
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 30, 2023
Est. completion date January 31, 2024

Study information

Verified date January 2023
Source Federal University of Health Science of Porto Alegre
Contact Fernanda Cechetti
Phone 3303-8700
Email nandacecheti@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date January 31, 2024
Est. primary completion date December 3, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years to 95 Years
Eligibility 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 Design


Intervention

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.
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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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.
Secondary 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)
Secondary 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.
Secondary 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.
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