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Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure

4. desember 2015 oppdatert av: Naomi Kondo Nakagawa

Inspiratory Muscle and Peripheral Muscle Combined Training Effects on the Respiratory and Functional Capacity and Quality of Life in Chronic Heart Failure

Heart failure is a clinical syndrome that is the common end of several cardiac diseases with symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve respiratory and general functional capacity of these patients, there are strategies that can be used such as inspiratory muscle training and peripheral muscle training (dynamic resistance training).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

After agreement with the written informed consent, 35 subjects with severe heart failure were included in this study. They were randomized in three groups: controls, low-intensity and moderate-intensity group. All volunteers were assessed at Baseline and 8-weeks intervention. Cardiac events were registered following two years from baseline. The present study aimed to assess the effects of a combined program of inspiratory and peripheral muscle training on respiratory and general functional capacity and quality of life in patients with chronic heart failure.

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Brasil
      • Sao Paulo, Brasil, 04012-909
        • Instituto Dante Pazzanese de Cardiologia

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år til 68 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • chronic heart failure (functional class from NYHA II and III),
  • left ventricle ejection fraction bellow or equal 40%.

Exclusion Criteria:

  • uncontrolled arrhythmia
  • pulmonary edema or pulmonary congestion in the last 30 days
  • peripheral oxygen saturation bellow 92% in resting condition
  • respiratory infection in the previous 30 days to the enrollment into the study
  • cognitive, neurological or orthopedic limitations

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Control group
patients awaiting for evaluation to cardiac rehabilitation or transplantation
Annen: control
No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation
Eksperimentell: moderate-intensity group
Patients will be submitted to a 8-weeks training program, with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with upper and lower exercises (50% of the 1-maximum repetition test).
Annen: moderate-intensity group
Patients will be submitted to a 8-weeks training program with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (50% 1 RM, increased every 2-weeks).
Aktiv komparator: low-intensity group
Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 Kg each).
Annen: low-intensity group
Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 kg each)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in respiratory muscle strength (in centimeters of water)
Tidsramme: Before and after 8-weeks
Inspiratory and expiratory muscle strength was assessed by using a pressure transducer (MVD-300 Microhard System, GlobalMed, Porto Alegre, Brazil).
Before and after 8-weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
walking distance
Tidsramme: Before and after 8-weeks
To assess functional capacity using walking distance (6-min walk test accordingly to ATS and ERS guidelines)
Before and after 8-weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in pulmonary function
Tidsramme: Before and after 8-weeks
Pulmonary function will be assessed by spirometry.
Before and after 8-weeks
Change in functional capacity
Tidsramme: Before and after 8-weeks
1RM
Before and after 8-weeks
Inflammation in the upper airway by cytokines in blood
Tidsramme: Before and after 8-weeks
MMP2, myoglobin, p-selectin, MPO, NGAL, sVCAM, IL-2, IL-3, IL-4, IL-8,MIP1-alpha, 17, VEGF by Multiplex analysis. Inflammatory cells in nasal lavage will be also investigated.
Before and after 8-weeks
Change in heart rate variability (HRV)
Tidsramme: Before and after 8-weeks
HRV is obtained from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland)
Before and after 8-weeks
Prevalence of cardiac events and arrhythmia
Tidsramme: Before and after 8-weeks
by a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs
Before and after 8-weeks
Change in international Physical Activity Questionnaire (IPAQ)
Tidsramme: Before and after 8-weeks
Patients will be classified as sedentary, irregularly active, active or verry active according to Matsudo's classification (2001).
Before and after 8-weeks
Change in quality of life using Minnesota Questionnaire
Tidsramme: Before and after 8-weeks

by Short Form-36 and by Minnesota Living with Heart Failure Questionnaire

- Minnesota living with heart failure questionaire: contains 21 questions of physical, social, economic and emotional aspects. Each question ranges from zero to five points, with a total score of 105 points which is the maximum severity degree related to personal perception of quality of life.
Before and after 8-weeks
Change in brain natriuretic peptide (BNP) analysis
Tidsramme: Before and after 8-weeks
A blood sample of 5 ml will be collected in a tube and BNP measured
Before and after 8-weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Naomi Kondo Nakagawa

Samarbeidspartnere

Fundação de Amparo à Pesquisa do Estado de São Paulo
Instituto Dante Pazzanese de Cardiologia

Etterforskere

  • Hovedetterforsker: Naomi K Nakagawa, PhD, USP

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2012

Primær fullføring (Faktiske)

1. oktober 2015

Studiet fullført (Faktiske)

1. desember 2015

Datoer for studieregistrering

Først innsendt

29. september 2014

Først innsendt som oppfylte QC-kriteriene

10. oktober 2014

Først lagt ut (Anslag)

13. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. desember 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. desember 2015

Sist bekreftet

1. desember 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CEP 232/12
  • FAPESP 2013/13598-1 (Annet stipend/finansieringsnummer: FAPESP 2013/13598-1)

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