Rehabilitation in Patients With Human Lymphotropic Virus Type I

NCT ID: NCT04875403

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-27
• Study Completion Date: 2022-12-30

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.

Conditions

Human T-Lymphotropic Virus Type 1 Associated Myelopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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%).

Group Type: EXPERIMENTAL

Inspiratory muscle trainning

Intervention Type: OTHER

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%.).

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

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

Interventions

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%.).

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Seropositive carriers for HTLV-1 with PET

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Estado do Pará

OTHER

Sponsor Role: collaborator

Universidade Metodista de Piracicaba

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Santiago Barbosa Rocha, Phd

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade do Estado do Pará

Belém, Pará, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Rodrigo S Rocha, Phd

Role: primary

fisiorocha2000@yahoo.com.br

91992340234

References

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.

Reference Type: RESULT

PMID: 32986997 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32692782 (View on PubMed)

Other Identifiers

01/2021

Identifier Type: -

Identifier Source: org_study_id