Belépés

NCT07763353Toborzás még nem indult

Effects of Slow-paced Breathing on Heart Rate Variability in Patients With Heart Failure

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 13.

Rövid összefoglaló (regiszter, angolul)

Background: Heart failure (HF) is a major global public health concern characterized by impaired cardiac function, high mortality, frequent hospital readmissions, and substantial healthcare burden. Autonomic nervous system (ANS) dysfunction plays a critical role in the pathophysiology of HF, typically presenting as increased sympathetic activity and reduced parasympathetic activity. Heart rate variability (HRV), a non-invasive marker of cardiac autonomic regulation, has been widely used to evaluate autonomic function and predict clinical outcomes in patients with HF. Reduced HRV is associated with increased risks of sudden cardiac death, cardiovascular events, and hospital readmission. Although cardiac rehabilitation (CR) has been demonstrated to improve exercise capacity, quality of life, and clinical outcomes in HF patients, its effects on autonomic modulation, particularly during Phase I cardiac rehabilitation, remain insufficiently investigated. Slow-paced breathing (SPB) has emerged as a potential non-pharmacological intervention for enhancing autonomic regulation. By synchronizing respiratory rhythm with cardiovascular oscillations, SPB may enhance baroreflex sensitivity, increase vagal activity, and improve HRV. Previous studies have suggested beneficial effects of SPB on autonomic function; however, the findings remain inconsistent, and evidence regarding its short-term effects on HRV among hospitalized HF patients undergoing early cardiac rehabilitation is limited. Therefore, further investigation is warranted to determine whether SPB can provide additional autonomic benefits when incorporated into Phase I cardiac rehabilitation. Objective: This study aims to investigate the effects of slow-paced breathing combined with Phase I cardiac rehabilitation on autonomic nervous system function in patients with heart failure, using HRV as the primary outcome measure. Methods: This study will employ a parallel randomized controlled trial design. Hospitalized patients diagnosed with heart failure will be randomly allocated into either the SPB intervention group or the control group. Both groups will receive standard Phase I cardiac rehabilitation, while the intervention group will additionally receive slow-paced breathing training. The primary outcomes will include changes in HRV parameters, including time-domain indices (standard deviation of NN intervals \[SDNN\] and root mean square of successive differences \[RMSSD\]) and frequency-domain indices (low-frequency power \[LF\], high-frequency power \[HF\], and LF/HF ratio), to evaluate changes in cardiac autonomic regulation before and after intervention.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
27 (tervezett)
Első benyújtás
2026. aug. 10.
Kezdés
2026. aug. 15.
Elsődleges befejezés
2027. aug. 14.
Fő szponzor
Chung Shan Medical University
NCT-szám
NCT07763353

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 27
  • 2026. aug. 15. és az elsődleges befejezés (2027. aug. 14.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Más betegség

  • Presence of an implanted cardiac pacemaker. Chronic pulmonary diseases, such as chronic obstructive pulmonary disease (COPD), pulmonary hypertension, pulmonary fibrosis, or exercise-induced asthma.
  • Current use of mechanical ventilation. Severe aortic stenosis. Aortic dissection. Acute myocarditis, pericarditis, or infective endocarditis. Inability to walk independently due to orthopedic, neurological, or other medical conditions.
  • Inability to understand the study protocols or cooperate, such as individuals with psychiatric disorders, dementia, or a history of stroke.

Egyéb

  • Respiratory distress at rest with the utilization of accessory neck muscles (neck breathing pattern).

Kiket keres a vizsgálat

  • Patients diagnosed with heart failure during hospitalization and who are clinically stable.

Életkor a regiszterben: 20 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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