- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07664774
Effects of Resonant Breathing on Blood Pressure, Heart Rate and Perceived Stress
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study is a randomized, parallel-group controlled trial conducted in community rehabilitation centers in Lahore, Pakistan. A total of 50 participants diagnosed with stage I hypertension will be enrolled and allocated into two groups using a computer-generated randomization sequence with allocation concealment.
Participants in both groups will undergo standard physiotherapy consisting of general warm-up exercises and stretching, performed under supervision three times per week for eight weeks. The intervention group will additionally receive resonant breathing training, delivered as a structured breathing exercise performed for approximately 20 minutes per session.
Resonant breathing is a slow-paced breathing technique performed at approximately 4.5-7 breaths per minute with equal inhalation and exhalation phases. It is intended to improve autonomic balance by enhancing parasympathetic activity and reducing sympathetic nervous system dominance, thereby potentially improving cardiovascular and psychological outcomes.
Outcome assessments will be conducted at baseline and after 8 weeks. Primary outcomes include systolic blood pressure, diastolic blood pressure, heart rate, and perceived stress.
Blood pressure and heart rate will be measured using a validated automated digital sphygmomanometer. Perceived stress will be assessed using the Perceived Stress Scale (PSS-10).
Statistical analysis will be performed using SPSS version 26. Within-group comparisons will be analyzed using paired t-tests, while between-group comparisons will be assessed using independent t-tests. Effect size will be calculated using Cohen's d, with statistical significance set at p < 0.05.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Punjb
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Lahore, Punjb, Pakistan
- Different Commuinty Center in Lahore
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Adults age 30-65 years
- Patients with hypertension stage I
- Patients with no serious comorbidities
- Not currently in any breathing therapy or rehabilitation programs
Exclusion Criteria:
- Age under 30 or over 65
- Patients with severe hypertension (stage II or III)
- Patients with serious comorbidities
- Patients taking medicines affecting blood pressure or heart rate
- Current use of tobacco or materials that may have an effect on blood pressure or stress level
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Experimental Group
Group A: Will undergo a traditional physical therapy exercise program along with an eight-week resonant breathing program, with 20 minutes of supervised practice, three times a week.
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Resonant breathing, or Coherent Breathing, is a slow, rhythmic technique focusing on equal inhales and exhales (often 5-6 seconds each) to calm the nervous system, improve heart rate variability (HRV), and reduce stress by aligning breath with heart rhythms.
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Placebo-Komparator: Control group
Group B: Will continue with the baseline physiotherapy intervention (general warm-up exercises and stretching) throughout the study period, with no resonant breathing or specific breathing exercises included.
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Resonant breathing, or Coherent Breathing, is a slow, rhythmic technique focusing on equal inhales and exhales (often 5-6 seconds each) to calm the nervous system, improve heart rate variability (HRV), and reduce stress by aligning breath with heart rhythms.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Blood pressure
Zeitfenster: 8 week
|
Blood pressure will be measured using a cuff wrapped around your upper arm.
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8 week
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heart rate
Zeitfenster: 8 week
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To measure heart rate, find your pulse on your wrist or neck, count beats for 15 or 30 seconds, then multiply to get beats per minute (bpm)
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8 week
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perceived stress
Zeitfenster: 8 week
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Perceived Stress Scale (PSS) scoring involves answering 10 (or 14/4) questions on a 0 (never) to 4 (very often) scale, then reversing scores for specific items (4, 5, 7, 8 for PSS-10) before summing them to get a total score (0-40 for PSS-10), with higher scores meaning more perceived stress, generally falling into low (0-13), moderate (14-26), and high (27-40) categories, though it's a self-assessment tool, not a diagnostic one.
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8 week
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Maryum Khan, MS, Riphah International University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Spruill TM. Chronic psychosocial stress and hypertension. Curr Hypertens Rep. 2010 Feb;12(1):10-6. doi: 10.1007/s11906-009-0084-8.
- Scott SB, Whitehead BR, Bergeman CS, Pitzer L. Combinations of stressors in midlife: examining role and domain stressors using regression trees and random forests. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):464-75. doi: 10.1093/geronb/gbs166. Epub 2013 Jan 22.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Syeda Fatima Zaheer Rizvi
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