NCT05610696

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 20, 2022

Last Update Submit

January 18, 2023

Conditions

Keywords

OsteoarthritisHydrotherapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Degree of pain over time

    Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.

  • Edema over time

    Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention)

  • Flexibility over time

    Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.

  • Muscle strength over time

    Baseline moment (immediately before the intervention), moment 1 (immediately after the intervention) measured in all interventions.

Study Arms (3)

Low impact immersion

EXPERIMENTAL

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

Other: Low impact immersion

Conventional aquatic physiotherapy

EXPERIMENTAL

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

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

Other: High intensity aquatic physiotherapy

Interventions

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.

Low impact immersion

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.

Conventional 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.

High intensity aquatic physiotherapy

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Fernanda Cechetti

CONTACT

A Teixeria

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized clinical trial, of the crossover type
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

January 20, 2022

First Posted

November 9, 2022

Study Start

March 30, 2023

Primary Completion

December 3, 2023

Study Completion

January 31, 2024

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share