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Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of HFpEF (TRAINING-HF)

17 maggio 2017 aggiornato da: Universitat Jaume I

Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction

Heart failure (HF) with preserved ejection fraction (HFpEF) has become the most prevalent form of HF in developed countries. Despite its increasing in prevalence, there is no evidence-based effective therapy for HFpEF The purpose of this study was to evaluate whether inspiratory muscle training (IMT), functional electrical stimulation (FES), or combination of both improve exercise capacity as well as left ventricular diastolic function, biomarkers' profile, quality of life (QoL) and prognosis in patients with HFpEF.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study was designed as a prospective, controlled, randomized, four-armed, efficacy trial of patients with the diagnosis of HFpEF and New York Heart Association functional class II-III/IV, diagnosed according to criteria of the European Society of Cardiology. A computer-generated randomization scheme was used to allocate participants (in a 1:1:1:1 ratio) to receive: 1) a home-based 12-week program of inspiratory muscle training (IMT) or; 2) a 12-week program of functional electrical stimulation (FES) of lower limb muscles or; 3) standard treatment (ST) alone or; 4) combination of IMT and FES. The study is being conducted in a single center in Spain. Independently of staggered entry, the minimum duration of a patient's participation is 6 months (from first to last visit). All patients will provide signed informed consent and the protocol has been approved by the research ethics committee of our center in accordance with the principles of the Declaration of Helsinki and national regulations.

Study population Candidate patients are selected from the outpatient's clinics of HF of the Hospital Clínico Universitario of Valencia.

Study objectives The primary endpoint of the study is a clinical endpoint of three and six months change in peak oxygen uptake (peak VO2).

Secondary endpoints are three and six month changes in echocardiogram parameters, QoL and prognostic biomarkers. The investigators also will specifically focus on number of episodes of worsening HF at 6 months:

  1. Change in E/e' after three and six months.
  2. Change in left atrial volume index after three and six months.
  3. Change in health-related QoL measured by the Minnesota Living With Heart Failure Questionnaire (MLHF) after three and six months.
  4. Change in natriuretic peptide (NT-proBNP) after three and six months.
  5. Change in minute ventilation/carbon dioxide production (VE/VCO2) slope after three and six months.
  6. Number of episodes of acute HF hospitalizations and number of episodes of worsening HF not requiring hospitalization at 6 months.

Intervention

Eligibility assessment and screening visit After reviewing the inclusion/exclusion criteria and signing the informed consent form, a comprehensive medical history, physical examination, anthropometry and examination tests will be performed. The examination tests include: electrocardiogram (ECG) echocardiography, cardiopulmonary exercise testing (CPET), 6-minute walk test (6-MWT), inspiratory muscle function test, QoL assessment by the Minnesota Living With Heart Failure Questionnaire (MLHF) and blood samples for a panel of baseline biomarkers.

Finally, patients are randomized (1:1:1:1) to four groups: 1) ST alone or; 2) a home-based 12-week program of IMT or; 3) a 12-week program of FES or; 4) combination of IMT and FES (IMT+FES) during 12 weeks.

12-week and six months visits All patients will be evaluated after 12-week supervised training, and six months after randomization. Evaluation will include medical history, physical examination, anthropometry and functional and QoL assessment tests (ECG, CPET, 6-MWT, inspiratory muscle function test, MLHF and blood tests).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

52

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
      • Valencia, Spagna, 46010
        • Hospital Clinico Universitario de Valencia

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Previous history of symptomatic heart failure NYHA (New York Heart Association )functional class ≥II with Normal left ventricular ejection fraction:

    • ejection fraction >0.50 by Simpson method
    • end-diastolic diameter <60 mm

  • Structural heart disease:

    • left ventricle hypertrophy/left atrial enlargement and/or
    • diastolic dysfunction estimated by 2D echocardiography
  • Previous admission for acute heart failure
  • Clinical stability, without hospital admissions in the past 3 month

Exclusion Criteria:

  • Perform a valid baseline exercise test
  • Significant primary moderate to severe valvular disease
  • Acute coronary syndrome or cardiac surgery within the previous three months
  • Signs of ischemia during cardiopulmonary exercise testing
  • Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease
  • Any other comorbidity with an expectancy of life less than one year

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Standard treatment
Only standard medical treatment
Altro: Standard treatment
Patients allocated to this arm will not receive any physical therapy, only standard medical treatment. They will be checked weekly by a physiotherapist who measures their maximal inspiratory mouth pressure each time.
Comparatore attivo: IMT group
Standard medical treatment associated to Inspiratory muscle training
Altro: IMT
Patients allocated to IMT arm will receive standard medical treatment and will be instructed to train at home twice daily, for 20 minutes each session, and during 12 weeks using a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them will be instructed by a respiratory therapist and educated to maintain a diaphragmatic breathing during the training period. The subjects start breathing at a resistance equal to 25-30% of their maximal inspiratory pressure (MIP) for 1 week. The respiratory therapist examines the patients at weekly intervals by checking the diary card and measuring their MIP each time. The resistance is modified each session according to their 25-30% of their MIP measured.
Altri nomi:
  • Inspiratory muscular training
Comparatore attivo: FES group
Standard medical treatment associated to functional electrostimulation of both legs for 45 minutes a day, 2 days per week for a total of 12 weeks.
Altro: FES
Patients allocated to FES arm will receive standard medical treatment and will be trained in a FES program of both legs by a physiotherapist for 45 minutes a day, 2 days per week for a total of 12 weeks. Eight adhesive electrodes are positioned on the skin over the quadriceps and gastrocnemius muscles of both legs. The stimulator is configured to deliver a direct electrical current at 25 Hz for 5 seconds followed by a 5-second rest. The intensity of the stimulation is adjusted to achieve a visible muscle contraction without discomfort.
Altri nomi:
  • Functional electrostimulation of lower limbs
Comparatore attivo: IMT+FES group
Standard medical treatment associated to combination of inspiratory muscle training and functional electrostimulation of both legs
Altro: IMT
Patients allocated to IMT arm will receive standard medical treatment and will be instructed to train at home twice daily, for 20 minutes each session, and during 12 weeks using a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them will be instructed by a respiratory therapist and educated to maintain a diaphragmatic breathing during the training period. The subjects start breathing at a resistance equal to 25-30% of their maximal inspiratory pressure (MIP) for 1 week. The respiratory therapist examines the patients at weekly intervals by checking the diary card and measuring their MIP each time. The resistance is modified each session according to their 25-30% of their MIP measured.
Altri nomi:
  • Inspiratory muscular training
Altro: FES
Patients allocated to FES arm will receive standard medical treatment and will be trained in a FES program of both legs by a physiotherapist for 45 minutes a day, 2 days per week for a total of 12 weeks. Eight adhesive electrodes are positioned on the skin over the quadriceps and gastrocnemius muscles of both legs. The stimulator is configured to deliver a direct electrical current at 25 Hz for 5 seconds followed by a 5-second rest. The intensity of the stimulation is adjusted to achieve a visible muscle contraction without discomfort.
Altri nomi:
  • Functional electrostimulation of lower limbs

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional capacity measured as peak oxygen uptake (peak VO2) in ml/min/kg .
Lasso di tempo: changes at 12 weeks and 6 months

Maximal functional capacity will be evaluated with an incremental and symptom-limited cardiopulmonary exercise testing (CORTEX Metamax 3B) on a bicycle ergometer, beginning with a workload of 10 W and increasing stepwise at 10-W increments every 1 min. During exercise, patients were continuously monitored with twelve-lead electrocardiogram and blood pressure measurements every 2 min. Gas exchange data and cardiopulmonary variables were averaged every 10 seconds values. Peak VO2 is considered the highest value of VO2 during the last 20 s of exercise.

The improvement > of 10% in peak VO2 will be considered clinically meaningful
changes at 12 weeks and 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional capacity measured as distance walked in 6 minutes
Lasso di tempo: changes at 12 weeks and 6 months
Patients will be instructed to cover the maximum distance (meters) possible in six minutes, at a self-graded walking speed, pausing to rest when needed. Each subject will undergo 4 tests. The goal of the first one was to allow the patient to familiarize with the test.
changes at 12 weeks and 6 months
Change in echocardiographic parameter of diastolic disfunction: e' septal (cm/s)
Lasso di tempo: changes in rest at 12 weeks and 6 months

Doppler echocardiogram examination of e' septal (cm/s) will be performed under resting conditions using 2D echocardiography (iE33, Philips). e' septal (cm/s) parameter will be measured according to current guidelines of the European Society of Echocardiography:

Only significant improvements in this parameter will be considered
changes in rest at 12 weeks and 6 months
Change in echocardiographic parameter of diastolic disfunction: left atrial volume index (mm/m2)
Lasso di tempo: changes in rest at 12 weeks and 6 months

Doppler echocardiogram examination of left atrial volume index (mm/m2) will be performed under resting conditions using 2D echocardiography (iE33, Philips). Left atrial volume index (mm/m2) will be measured according to current guidelines of the European Society of Echocardiography.

Only significant improvements in this parameter will be considered
changes in rest at 12 weeks and 6 months
Change in echocardiographic parameter of diastolic disfunction: E/e' ratio
Lasso di tempo: changes in rest at 12 weeks and 6 months

Doppler echocardiogram examination of E/e' ratio will be performed under resting conditions using 2D echocardiography (iE33, Philips). E/e' ratio parameter will be measured according to current guidelines of the European Society of Echocardiography.

Only significant improvement in this parameter will be considered
changes in rest at 12 weeks and 6 months
Change in health-related QoL
Lasso di tempo: changes at 12 weeks and 6 months
Change in health-related QoL will be measured by the Minnesota Living With Heart Failure Questionnaire (no units) Only significant improvements in these parameters will be considered
changes at 12 weeks and 6 months
Number of rehospitalizations or worsening HF at 6 months
Lasso di tempo: changes at 6 months
Number of episodes of acute HF hospitalizations and number of episodes of worsening HF not requiring hospitalization at 6 months among different arms.
changes at 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universitat Jaume I

Collaboratori

INCLIVA
Hospital Clínico Universitario de Valencia

Investigatori

  • Investigatore principale: Patricia Palau, M.D., PhD, Universitat Jaume I
  • Direttore dello studio: Eloy Domínguez, M.D, Universitat Jaume I
  • Cattedra di studio: Julio Núñez, M.D., PhD, Universitat de València

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2015

Completamento primario (Effettivo)

1 gennaio 2017

Completamento dello studio (Effettivo)

1 marzo 2017

Date di iscrizione allo studio

Primo inviato

1 dicembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

22 dicembre 2015

Primo Inserito (Stima)

23 dicembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 maggio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 maggio 2017

Ultimo verificato

1 maggio 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IMT-FES 01

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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