Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure
4. december 2015 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
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
-
-
-
Sao Paulo, Brasilien, 04012-909
- Instituto Dante Pazzanese de Cardiologia
-
-
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
14 år til 66 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Control group
patients awaiting for evaluation to cardiac rehabilitation or transplantation
|
No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation
|
|
Eksperimentel: 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).
|
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).
|
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)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Naomi K Nakagawa, PhD, USP
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. oktober 2012
Primær færdiggørelse (Faktiske)
1. oktober 2015
Studieafslutning (Faktiske)
1. december 2015
Datoer for studieregistrering
Først indsendt
29. september 2014
Først indsendt, der opfyldte QC-kriterier
10. oktober 2014
Først opslået (Skøn)
13. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. december 2015
Sidst verificeret
1. december 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CEP 232/12
- FAPESP 2013/13598-1 (Andet bevillings-/finansieringsnummer: FAPESP 2013/13598-1)
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 .