- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07573683
Additional Effect of Coherent Breathing With Aerobic Exercise on Cardiopulmonary Parameters and Quality of Life in Stage 1 Hypertensive Individuals
This study will use a randomized controlled trial to evaluate the added effects of coherent breathing combined with aerobic exercise versus aerobic exercise alone in 40 adults aged 30-65 with stage 1 hypertension. Participants will be randomly assigned to an intervention group (aerobic exercise plus coherent breathing) or a control group (aerobic exercise only) and will undergo a 4-week program with 5 sessions per week.
Cardiopulmonary parameters-including blood pressure, heart rate, respiratory rate, and rate pressure product-will be measured, and quality of life will be assessed using the MINICHAL questionnaire at baseline, 2 weeks, and post-intervention. Data will be analyzed using SPSS version 21.0.
The study aims to determine whether coherent breathing provides additional benefits, offering a cost-effective, non-pharmacological strategy for hypertension management in low-resource settings.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Hypertension, also known as high or raised blood pressure, is a condition in which the blood vessels have persistently raised pressure. A normal reading is less than 120 millimeters of mercury over less than 80 millimeters of mercury. Hypertension is a prevalent condition affecting approximately 1.28 billion individuals globally, with a significant burden observed in low- and middle-income countries such as Pakistan. Stage 1 hypertension is defined by a systolic blood pressure (SBP) between 130-139 mmHg or diastolic blood pressure (DBP) between 80-89 mmHg. High blood pressure causes no signs or symptoms, which is why healthcare providers call it a "silent killer." Non-pharmacological interventions, including aerobic exercise and breathing techniques, have shown promise in improving cardiopulmonary function and quality of life.
Coherent breathing is a controlled breathing technique that involves inhaling and exhaling at a steady, slow pace-typically around five to six breaths per minute, with each inhale and exhale lasting about six seconds. This study aims to evaluate the additional effects of coherent breathing techniques when combined with aerobic exercise, compared to aerobic exercise alone. A randomized controlled trial design will be employed. The study will be conducted over a period of 1 year at Foundation University College of Physical Therapy and Fauji Foundation Hospital Rawalpindi. Ethical approval will be obtained from ERC FUMC and IRC, and the trial will be registered with CBRC and the clinical trial registry. Data will be analyzed using SPSS version 21.0.
This study will fill a critical gap in the literature by assessing the additive benefits of coherent breathing in hypertension management. The findings may support cost-effective, non-pharmacological strategies in low-resource settings, contributing to improved public health outcomes
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Kainat Zahra, MSPT-CPPT
- Puhelinnumero: 03367343005
- Sähköposti: zahrakainat99@gmail.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Syeda Sumaira Batool, MSPT-CPT
- Puhelinnumero: 03328868680
- Sähköposti: sumaira.batool@fui.edu.pk
Opiskelupaikat
-
-
-
Islamabad, Pakistan
- Rekrytointi
- Foundation University Islamabad
-
Ottaa yhteyttä:
- Syeda Sumaira Batool, MSPT-CPT
- Puhelinnumero: 03328868680
- Sähköposti: sumaira.batool@fui.edu.pk
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Both male and female genders.
- Adults aged 30-65 years.
- Patients diagnosed with stage 1 hypertension 130-139/80-89mm Hg according to ACC/AHA 2017 guidelines.
- Mild to moderate physical activity level on IPAQ questionnaire.
- Individuals able to understand and follow the instructions.
Exclusion Criteria:
- Diagnosed uncontrolled hypertensive patients.
- Unstable angina, MI, heart failure, advanced CAD patients, COPD, Asthma.
- Severe neurological, musculoskeletal or gynecological conditions which limit participation in the study.
- Recent history of fracture.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Aerobic Exercises
This Group performs aerobic exercises as follows: Week 1-2 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform simple breathing for 10 minutes. FREQUENCY: 5 days / week INTENSITY: 50 - 60% THR TIME: 40 minutes TYPE: Aerobic exercises & simple breathing Week 3-4 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform simple breathing exercies for 10 minutes. FREQUENCY: 5 days / week INTENSITY: 60 - 80% THR TIME: 40 minutes TYPE: Aerobic exercises & simple breathing. A total of 20 sessions Five days per week for 4 weeks. |
Aerobic Exercises involving brisk walking, warm up, stepper, static cycling, cool down for a periof of 30 min.
|
|
Kokeellinen: Aerobic Exercises with coherent breathing
This group performs aerobic exercises combined with coherent breathing technique. Week 1-2 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform coherent breathing technique for 10 min. FREQUENCY: 5 days / week INTENSITY: 50 - 60% THR TIME: 30 minutes TYPE: Aerobic exercises. Coherent Breathing technique for 10 minutes. TOTAL DURATION: 40 minutes Week 3-4 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform coherent breathing technique for 10 min. FREQUENCY: 5 days / week INTENSITY: 60 - 80% THR TIME: 30 minutes TYPE: Aerobic exercises |
Coherent breathing technique involve consciously reducing the breathing rate, typically to fewer than 10 breaths per minute, often around 6 breaths per minute. Coherent breathing is performed for 10 minutes. Aerobic Exercises involving brisk walking, warm up, stepper, static cycling, cool down for a period of 30 min. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Heart Rate (beats per minute)
Aikaikkuna: 04 weeks
|
Measured using calibrated digital monitor after 5 minutes rest at baseline and post-intervention.
|
04 weeks
|
|
Systolic Blood Pressure (mmHg)
Aikaikkuna: 04 weeks
|
Measured using standardized sphygmomanometer at baseline and post-intervention.
|
04 weeks
|
|
Diastolic Blood Pressure (mmHg)
Aikaikkuna: 04 weeks
|
Measured using standardized sphygmomanometer at baseline and post-intervention.
|
04 weeks
|
|
Peripheral Oxygen Saturation (SpO₂, %)
Aikaikkuna: 04 weeks
|
Measured using pulse oximeter under resting conditions at baseline and post-intervention.
|
04 weeks
|
|
Respiratory Rate (breaths/minute)
Aikaikkuna: 04 weeks
|
Measured by direct observation at baseline and post-intervention.
|
04 weeks
|
|
Rate Pressure Product (HR × SBP)
Aikaikkuna: 04 weeks
|
Calculated from heart rate and systolic blood pressure at baseline and post-intervention as an index of myocardial workload.
|
04 weeks
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- FUCP/CTR/2026/06
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .