- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07664774
Effects of Resonant Breathing on Blood Pressure, Heart Rate and Perceived Stress
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjb
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Lahore, Punjb, Pakistan
- Different Commuinty Center in Lahore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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 Comparator: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maryum Khan, MS, Riphah International University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Syeda Fatima Zaheer Rizvi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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