Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients (Reperate3)
The Effect of Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients With Hypertension (Resperate-3) A Randomized, Double-blind Controlled Trial
Rationale: Hypertension is an important risk factor of cardiovascular disease, especially in patients with type 2 diabetes mellitus (T2DM). A relatively recent development for the treatment of hypertension is the use of breathing exercises. The investigators' previous studies with a breathing device did not show any positive results. However, these studies and other trials investigating the effects of breathing devices had not a double-blind design. Therefore, the investigators want to perform a randomized, double-blind, controlled trial in a population of T2DM patients.
Objective: To determine the effect of a device slowing breathing (Resperate©) on office systolic blood pressure (SBP) in diabetic patients with treated hypertension with moderate BP control.
Study design: A randomized, double-blind, controlled trial.
Study population: Patients with type 2 diabetes mellitus, over 18 years old and a baseline systolic blood pressure between 140-160 mm Hg.
Intervention: One group receives treatment with a breathing device (Resperate©) and the other group receives treatment with a "control" breathing device. The latter device does not try to alter the breathing pattern.
Main study parameters/endpoints: The effect of the breathing device on SBP is the main study parameter. Secondary endpoints include diastolic blood pressure (DBP) and quality of life.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Zwolle, Olanda, 8000 GM
- Isala Clinics
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Zwolle, Olanda, 8000 GM
- Isala Clinics, Diabetes Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- known T2DM,
- over 18 years old,
- known hypertension with a systolic BP (SBP) between 130-170 mm Hg at the previous visit to the internal outpatient department and at the last visit to the internist (which is the same day as baseline measurement) and treated with one or more anti-hypertensive drugs, which have not been changed for the preceding three months. At baseline the SBP should be between 140-160 mm Hg, measured by the investigator.
Exclusion Criteria:
- patients with orthostatic hypotension,
- known heart failure (NYHA III-IV) and/or patients with pulmonary disease (for example asthma, chronic obstructive pulmonary disease and pulmonary fibrosis),
- patients with insufficient knowledge of the Dutch language to understand the requirements of the study,
- additional criteria were hospitalization in the past 3 months, deafness, blindness and cognitive abilities deemed insufficient for operation of a study device.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: resperate device
Resperate© is a device that helps to slow down breathing.
This device can measure the breathing patterns through a breathing sensor mounted on the upper abdomen or chest.
Furthermore, music-like sound patterns can be composed similar to this breathing pattern, which the patient can hear through the headphones of the Resperate©.
By prolonging the expiration, which can be voluntarily used by the user, the frequency of respiration can be slowed down and become more stable (aim"<10 breathings per minute).
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device-guided breathing exercises
breathing device without slowing of breathing frequency
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Comparatore fittizio: control device
Resperate device without slowing of breathing
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device-guided breathing exercises
breathing device without slowing of breathing frequency
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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The effect of the breathing device on SBP is the main study parameter
Lasso di tempo: 8 weeks
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8 weeks
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Secondary endpoints include diastolic blood pressure (DBP) and quality of life.
Lasso di tempo: 8 weeks
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8 weeks
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Collaboratori e investigatori
Investigatori
- Direttore dello studio: HEnk J.G. Bilo, MD, PhD, Professor, FRCP, Diabetes centre, isala clinics
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Reperate3
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