- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07600879
Effects Of A Rehabilitation Protocol On Muscle Strength, Muscle Fatigue And Postural Control In Post-Dengue And Chikungunya Patients
20. maj 2026 opdateret af: Maria Cláudia Valente Almeida, Universidade do Estado do Pará
Effects Of A Rehabilitation Protocol On Muscle Strength, Muscle Fatigue And Postural Control In Post-Dengue And Chikungunya Patients: Non-Randomized Clinical Trial
Introduction: Dengue and Chikungunya arboviral diseases are considered major public health challenges in tropical regions due to high infection rates and the occurrence of musculoskeletal sequelae that impair strength, balance, and functionality.
After the acute phase, symptoms such as fatigue, joint pain, muscle weakness, and postural instability are common, reducing quality of life and hindering social and occupational reintegration.Objective: To analyze the effects of a rehabilitation protocol on muscle fatigue, muscle strength, and postural control in post-Dengue and Chikungunya patients.Methods:
This is a non-randomized clinical trial conducted at the Integrated Laboratory for Research and Care in Infectious and Sequelae Diseases (LabDIS/UEPA).
Individuals of both sexes, aged over 18 years, with a confirmed diagnosis of Dengue and/or Chikungunya within the last five years will be included.
Data collection will include a clinical interview, surface electromyography of the flexor carpi radialis, tibialis anterior, lateral and medial gastrocnemius muscles, hydraulic and electronic dynamometry, manovacuometry, and baropodometry.
The rehabilitation protocol will consist of twenty supervised sessions of aerobic, anaerobic, and respiratory exercises.Expected Results: Improvements in muscle strength, muscle fatigue, and postural control are expected following the intervention.Conclusion:
The findings may support physiotherapeutic strategies aimed at improving strength, fatigue, and balance, expanding knowledge on the neuromuscular and respiratory consequences of arboviral diseases, and contributing to the development of evidence-based rehabilitation protocols, with potential positive impacts on healthcare delivery and public health policies.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
54
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Maria Cláudia V Almeida, Principal Investigator
- Telefonnummer: +55 (91) 99102-9191
- E-mail: maria.cv.almeid@aluno.uepa.br
Studiesteder
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Pará
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Belém, Pará, Brasilien, 66.087-670
- Universidade Do Estado Do Pará
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Kontakt:
- Márcio C de souza santos, Coordinator
- Telefonnummer: +55 (91) 98134-9895
- E-mail: marcio.clementino@gmail.com
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Adults aged 18 years or older
- Individuals of both sexes
- Residents of the 1st, 4th, or 11th Health Regions of the state of Pará
- Confirmed diagnosis of Dengue (DENV) and/or Chikungunya (CHIKV) infection by serological testing (ELISA or IgG/IgM)
- Diagnosis confirmed within the last 5 years
- Ability to provide written informed consent
Exclusion Criteria:
- Hemodynamic instability
- Musculoskeletal instability, including fractures or acute muscle injuries
- Cognitive deficits impairing the understanding of commands or study procedures
- History of balance disorders prior to Dengue or Chikungunya infection
- Obesity
- Blindness or low vision
- Hearing impairment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention Group
Post-Dengue And Chikungunya Patients
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The rehabilitation protocol will include 20 sessions, twice weekly.
Anaerobic training will involve vertical chest press, lat pulldown, leg extension, and 180° leg press, with a prior 1RM test.
Sessions 1-5 and 11-15: 3 sets of 12 reps at 55% 1RM; sessions 6-10 and 16-20: 3 sets of 15 reps at 55% 1RM.
Aerobic training will be performed on a treadmill or cycle ergometer, progressing from 41-50% HRR (sessions 1-5), 51-60% (6-10), 61-70% (11-15), and 71-80% (16-20).
Respiratory training will use the PowerBreathe® device: sessions 1-10 at 30% MIP with 10 repetitions, and sessions 11-20 at 40% MIP with 10 repetitions.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Muscle fatigue assessed by surface electromyography
Tidsramme: Baseline and immediately after completion of the intervention protocol
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Surface electromyography (EMG) will be used to evaluate muscle activity and fatigue of the flexor carpi radialis, tibialis anterior, medial gastrocnemius, and lateral gastrocnemius muscles using the New Miotool Wireless® system.
Muscle fatigue will be analyzed through Mean Frequency (MNF) slope during sustained isometric contraction
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Baseline and immediately after completion of the intervention protocol
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Handgrip strength assessed by hydraulic dynamometry
Tidsramme: Baseline and immediately after completion of the intervention protocol
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Handgrip strength will be measured using a calibrated Crown® hydraulic hand dynamometer following the American Society of Hand Therapists (ASHT) recommendations.
Maximal isometric grip strength will be recorded in kilogram-force (kgf).
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Baseline and immediately after completion of the intervention protocol
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Peripheral muscle strength assessed by electronic dynamometry
Tidsramme: Baseline and immediately after completion of the intervention protocol
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Maximum isometric muscle strength of wrist flexors/extensors and ankle dorsiflexors/plantar flexors will be assessed using the MedEOR Medtech® digital dynamometer.
Strength values will be recorded in kilogram-force (kgf).
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Baseline and immediately after completion of the intervention protocol
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Postural control assessed by baropodometry
Tidsramme: Baseline and immediately after completion of the intervention protocol
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Postural control and plantar pressure distribution will be evaluated using the Footwork Pro AM³ pressure platform.
Stabilometric variables will include center of pressure displacement, oscillation area, and postural sway under eyes-open and eyes-closed conditions.
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Baseline and immediately after completion of the intervention protocol
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Respiratory muscle strength assessed by manovacuometry
Tidsramme: Baseline and immediately after completion of the intervention protocol
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Respiratory muscle strength will be assessed using a digital manovacuometer (MVD300-U).
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) will be measured in cmH₂O.
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Baseline and immediately after completion of the intervention protocol
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. juli 2027
Studieafslutning (Anslået)
30. juli 2027
Datoer for studieregistrering
Først indsendt
7. maj 2026
Først indsendt, der opfyldte QC-kriterier
14. maj 2026
Først opslået (Faktiske)
22. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Vektorbårne sygdomme
- Myggebårne sygdomme
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Arbovirus infektioner
- Flavivirus infektioner
- Flaviviridae infektioner
- Hæmoragiske feber, viral
- Alfavirus infektioner
- Togaviridae infektioner
- Dengue
- Chikungunya feber
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Øvelse
Andre undersøgelses-id-numre
- 7.646.502
Plan for individuelle deltagerdata (IPD)
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UBESLUTET
IPD-planbeskrivelse
For statistical analysis purposes, the data may be shared with the study advisor.
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