Effects of Resonant Breathing on Blood Pressure, Heart Rate and Perceived Stress
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Punjb
-
Lahore, Punjb, Pakistan
- Different Commuinty Center in Lahore
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood pressure
Tidsramme: 8 week
|
Blood pressure will be measured using a cuff wrapped around your upper arm.
|
8 week
|
|
heart rate
Tidsramme: 8 week
|
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)
|
8 week
|
|
perceived stress
Tidsramme: 8 week
|
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.
|
8 week
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Maryum Khan, MS, Riphah International University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Syeda Fatima Zaheer Rizvi
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .