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Rehabilitation in Patients With Human Lymphotropic Virus Type I

Primary Purpose

Human T-Lymphotropic Virus Type 1 Associated Myelopathy

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle trainning
Exercise
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human T-Lymphotropic Virus Type 1 Associated Myelopathy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Seropositive carriers for HTLV-1 with PET

Exclusion Criteria:

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

Sites / Locations

  • Universidade do Estado do ParáRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Respiratory muscle training group

Aerobic exercise group

Arm Description

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%).

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.

Outcomes

Primary Outcome Measures

Respiratory muscular strenght
The assessment of respiratory muscle strength will be carried out weekly by measuring the maximum inspiration pressure
Functional capacity
The assessment of functional capacity will be carried out weekly by six minute walk test

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
April 30, 2021
Sponsor
Universidade Metodista de Piracicaba
Collaborators
Universidade do Estado do Pará
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1. Study Identification

Unique Protocol Identification Number
NCT04875403
Brief Title
Rehabilitation in Patients With Human Lymphotropic Virus Type I
Official Title
Physical Functional Impacts of Rehabilitation in Patients With Human Lymphotropic Virus Type I
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba
Collaborators
Universidade do Estado do Pará

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human T-Lymphotropic Virus Type 1 Associated Myelopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Respiratory muscle training group
Arm Type
Experimental
Arm Description
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%).
Arm Title
Aerobic exercise group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle trainning
Intervention Description
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%.).
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Respiratory muscular strenght
Description
The assessment of respiratory muscle strength will be carried out weekly by measuring the maximum inspiration pressure
Time Frame
from baseline respiratory muscle stenght to 5 weeks
Title
Functional capacity
Description
The assessment of functional capacity will be carried out weekly by six minute walk test
Time Frame
from baseline functional capacity to 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Seropositive carriers for HTLV-1 with PET Exclusion Criteria: lung diseases heart disease arterial hypertension cognitive impairments
Facility Information:
Facility Name
Universidade do Estado do Pará
City
Belém
State/Province
Pará
ZIP/Postal Code
66055-490
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo S Rocha, Phd
Phone
91992340234
Email
fisiorocha2000@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32986997
Citation
Hirons A, Khoury G, Purcell DFJ. Human T-cell lymphotropic virus type-1: a lifelong persistent infection, yet never truly silent. Lancet Infect Dis. 2021 Jan;21(1):e2-e10. doi: 10.1016/S1473-3099(20)30328-5. Epub 2020 Sep 25.
Results Reference
result
PubMed Identifier
32692782
Citation
Pereira FM, Almeida MDCC, Santos FLN, Carreiro RP, Galvao-Castro B, Grassi MFR. Distribution of Human T-Lymphotropic Virus (HTLV) and Hepatitis C Co-infection in Bahia, Brazil. PLoS One. 2020 Jul 21;15(7):e0223087. doi: 10.1371/journal.pone.0223087. eCollection 2020.
Results Reference
result

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Rehabilitation in Patients With Human Lymphotropic Virus Type I

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