Rehabilitation in Patients With Human Lymphotropic Virus Type I

April 30, 2021 updated by: Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba

Physical Functional Impacts of Rehabilitation in Patients With Human Lymphotropic Virus Type I

In our times, it is known that approximately 5% of patients seropositive for HTLV-1 may desengage a frame with several neurological disorders, which is called myelopathy associated with HTLV-1, characterized for gait, decreased dynamic balance and limitation of walking independence the use of walkers, crutches as in wheelchairs. This evolution of the disease is based, above all, on muscle changes, such as inflammation of the muscles, which contributes to the attenuation of muscle capacity . In addition, muscle changes caused by HTLV-1 also affect the respiratory muscles, causing a change in respiratory mechanics, which can impair alveolar ventilation and, therefore, the development of a restorative respiratory disorder, reducing total lung capacity. Therefore, it is perceived the importance of offering planned rehabilitation according to the global assessment of the health status of these patients, considering their influence on activities of daily living.The focus of this study is on the weekly respiratory muscle training, as assessed by mensuration maximal inspiratory pressure, showed significant results in improving lung capacity and in this way promoting the prevention of pulmonary complications. Therefore, the protocol proposed by the present study includes respiratory muscular training plus resistance exercise, assessing the impact on both the strength muscular respiratory to as peripheral muscles, through the palmar pressure test and consequent enhancement of quality life and functionality of these patients. Furthermore, it will be possible to contribute to the knowledge of society and the scientific community about this theme, which is still very small in the world literature.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pará
      • Belém, Pará, Brazil, 66055-490
        • Recruiting
        • Universidade do Estado do Pará
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Seropositive carriers for HTLV-1 with PET

Exclusion Criteria:

  • lung diseases
  • heart disease
  • arterial hypertension
  • cognitive impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Respiratory muscle training group
Inspiratory muscle training with linear load device, associated with the resisted training. The initial training load for each participant will be adjusted to 25% of MIP. Each week, the researcher determines the new values for load (1 to week 25%, 2 to week 35%;. 3 to week 40%;. 4 to week 45%;. 5 to week 50%.).The resistance training protocol will consist of the exercises of the front pull, the extension chair and the vertical bench press, covering large muscle groups in the dorsal region of the quadriceps and chest, respectively. Each year consist of three sets of 10 repetitions with a load equivalent to 60% of a test Repetition Maximum (1RM), which will be changed every week (1 to week 60%, 2 to week 65%;. 3 the . week 70%, 4 to week. 75%, 5 to week 80%).
Other: Inspiratory muscle trainning
linear load device, associated with the resisted training. The initial training load for each participant will be adjusted to 25% of MIP. Each week, the researcher determines the new values for load (1 to week 25%, 2 to week 35%;. 3 to week 40%;. 4 to week 45%;. 5 to week 50%.).
Active Comparator: Aerobic exercise group
Exercise bike for 30 minutes, which will be divided into 10 minutes for the foot heating and 20 minutes for the workout aerobic exercise that will have to maintain a target training heart rate, training has to be equivalent to 40% to 60%% target intensity.
Other: Exercise
exercise bike for 30 minutes, which will be divided into 10 minutes for the foot heating and 20 minutes for the workout aerobic exercise that will have to maintain a target training heart rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory muscular strenght
Time Frame: from baseline respiratory muscle stenght to 5 weeks
The assessment of respiratory muscle strength will be carried out weekly by measuring the maximum inspiration pressure
from baseline respiratory muscle stenght to 5 weeks
Functional capacity
Time Frame: from baseline functional capacity to 5 weeks
The assessment of functional capacity will be carried out weekly by six minute walk test
from baseline functional capacity to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Metodista de Piracicaba

Collaborators

Universidade do Estado do Pará

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2021

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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