Human T-Lymphotropic Virus Type 1 Associated MyelopathyNCT04875403
Rehabilitation in Patients With Human Lymphotropic Virus Type I
A study testing Inspiratory muscle trainning and Exercise in people with Human T-Lymphotropic Virus Type 1 Associated Myelopathy, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Human T-Lymphotropic Virus Type 1 Associated Myelopathy
- What is being tested?
- Inspiratory muscle trainning and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Apr 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seropositive carriers for HTLV-1 with PET
Who cannot join
- lung diseases
- heart disease
- arterial hypertension
- cognitive impairments
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade do Estado do Pará
Belém, Pará, 66055-490
Rodrigo S Rocha, Phd, 91992340234, fisiorocha2000@yahoo.com.br
About this study
Official title: 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.
- Being tested
- Inspiratory muscle trainning, Exercise
- Medical subject headings
- Paraparesis, Tropical Spastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainningOther
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%.).
ExerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Respiratory muscle training group | Experimental | 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%). Receives: Other: Inspiratory muscle trainning |
| Aerobic exercise group | Active comparator | 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscular strenght
The assessment of respiratory muscle strength will be carried out weekly by measuring the maximum inspiration pressure
Measured: from baseline respiratory muscle stenght to 5 weeks
Functional capacity
The assessment of functional capacity will be carried out weekly by six minute walk test
Measured: from baseline functional capacity to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start27 Apr 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human T-Lymphotropic Virus Type 1 Associated MyelopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Estado do Pará
- Responsible party
- Principal investigator, Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875403
- Sponsor's protocol ID
- 01/2021
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32986997Pereira 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.
PubMed 32692782
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Functional Impacts of Rehabilitation in Patients With Human Lymphotropic Virus Type I
- ClinicalTrials.gov ID
- NCT04875403
- Acronym / sponsor ID
- 01/2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Collaborators
- Universidade do Estado do Pará
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Respiratory muscle training group | Experimental | Other: Inspiratory muscle trainningInspiratory 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%). |
| Aerobic exercise group | Active comparator | Other: ExerciseExercise 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Seropositive carriers for HTLV-1 with PET
Key exclusion criteria (4 listed)
- lung diseases
- heart disease
- arterial hypertension
- cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainninglinear 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%.). | Other | Respiratory muscle training group |
| Exerciseexercise 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 | Other | Aerobic exercise group |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Results publication: PubMed 32986997Hirons 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 publication: PubMed 32692782Pereira 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle trainning and Exercise in people with Human T-Lymphotropic Virus Type 1 Associated Myelopathy, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscular strenght (time frame: from baseline respiratory muscle stenght to 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04875403, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.