Clinical trial NCT04875403: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Human T-Lymphotropic Virus Type 1 Associated Myelopathy
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
Collaborators: name: Universidade do Estado do Pará
First posted: 2021-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Seropositive carriers for HTLV-1 with PET

Exclusion Criteria:

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

Primary outcomes:
measure: Respiratory muscular strenght
timeFrame: from baseline respiratory muscle stenght to 5 weeks
measure: Functional capacity
timeFrame: from baseline functional capacity to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Universidade do Estado do Pará
state: Pará
Study officials:
References:
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.
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.