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- Klinische proef NCT07664774
Effects of Resonant Breathing on Blood Pressure, Heart Rate and Perceived Stress
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Punjb
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Lahore, Punjb, Pakistan
- Different Commuinty Center in Lahore
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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-vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Blood pressure
Tijdsspanne: 8 week
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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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Maryum Khan, MS, Riphah International University
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Syeda Fatima Zaheer Rizvi
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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