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Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension

14. november 2019 opdateret af: Profa. Dra. Vera Lúcia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Impact of Peripheral Neuromuscular Electrical Stimulation on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension

Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic response, pulmonary function and exercise capacity.

Non-pharmacological interventions are low cost and can significant enhance outcomes in these patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable therapeutic approach in patients with functional limitations, particularly those that present with difficulty to perform exercise protocols.

Objective: to evaluate the impact of NMES on exercise capacity, spirometry values and quality of life of patients with PH.

Material and methods: prospective randomized controlled study with a control group (GC, n9) and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk test (6MWT) were assessed before and after the NMES protocol.

Results: the GE presented with a significant improvement in distance walked in the 6MWT, cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and social aspects of the questionnaire Short Form Health Survey-36.

Conclusion: NMES is a useful tool in the treatment of patients with PH, resulting in improved exercise capacity, quality of life and lung function testing.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
      • Sao Paulo, Brasilien, 01221-020
        • Santa Casa of Sao Paulo Medical School

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

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Males and females greater than or equal to 18 years of age, clinically stable with optimized drug therapy in the last 3 months, previously diagnosed with a mean pulmonary arterial pressure ≥ 25 mmHg by right heart catheterization and who agreed to participate by signing an informed consent were included.

Exclusion Criteria:

Exclusion criteria included a diagnosis of Down syndrome, orthopedic disease or neurologic or diagnoses, history of acute heart attack, use of beta-blockers, any urgent or elective surgical intervention during the implementation of the protocol, those who used assistive devices to ambulate or develop an infectious process during the study protocol.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control Group (GC)
The GC received standard ambulatory care, including routine exams and drug therapy. All patients were reassessed after the 2 month protocol.
Eksperimentel: NMES Group (GE)
Receiving the usual care and guidance on their illness, underwent 30 minute NMES sessions twice a week for two months using an electrostimulator. Specifically, 5 cm adhesive surface electrodes in four alternate channels on the Rectus Femoris (two channels the right and two on the left) were used to deliver two-phase symmetrical currents, with a rectangular pulse wave at a frequency of 35 Hz and pulse duration of 250 μ. The time of ascent and descent was one second, contraction time was four seconds and relaxation was eight seconds.
Andet: Neuromuskulær elektrisk stimulering

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Distance in six-minute walk test
Tidsramme: change from baseline in distance at 2 months
analysis of distance
change from baseline in distance at 2 months
Oxygen saturation in six-minute walk test
Tidsramme: change from baseline in oxygen saturation at 2 months
analysis of oxygen saturation at end of test
change from baseline in oxygen saturation at 2 months
Systolic blood pressure in six-minute walk test
Tidsramme: change from baseline in systolic blood pressure at 2 months
analysis of systolic blood pressure at end of test
change from baseline in systolic blood pressure at 2 months
Diastolic blood pressure in six-minute walk test
Tidsramme: change from baseline in diastolic blood pressure at 2 months
analysis of diastolic blood pressure at end of test
change from baseline in diastolic blood pressure at 2 months
Heart rate in six-minute walk test
Tidsramme: change from baseline in heart rate at 2 months
analysis of heart rate at end of test
change from baseline in heart rate at 2 months
Borg scale in six-minute walk test
Tidsramme: change from baseline in Borg scale at 2 months
analysis of Borg scale at end of test
change from baseline in Borg scale at 2 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Medical Outcomes Study 36-item Short Form Health Survey
Tidsramme: change from baseline at 2 months
The questionnaire covers 36 items, designed to assess health concepts
change from baseline at 2 months
Forced vital capacity
Tidsramme: change from baseline at 2 months
spirometric analysis
change from baseline at 2 months
Forced expiratory volume in the first second
Tidsramme: change from baseline at 2 months
spirometric analysis
change from baseline at 2 months
Forced expiratory flow 25-75 %
Tidsramme: change from baseline at 2 months
spirometric analysis
change from baseline at 2 months
Ratio of forced expiratory volume in the first second and forced vital capacity
Tidsramme: change from baseline at 2 months
spirometric analysis
change from baseline at 2 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

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

1. juni 2014

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

8. marts 2016

Først indsendt, der opfyldte QC-kriterier

14. marts 2016

Først opslået (Skøn)

18. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. november 2019

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Parece 517.472

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Pulmonal hypertension

Kliniske forsøg med Neuromuskulær elektrisk stimulering

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Tanzania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner