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Recruiting NCT07573683

Additional Effect of Coherent Breathing With Aerobic Exercise on Cardiopulmonary Parameters and Quality of Life in Stage 1 Hypertensive Individuals

No phase Interventional Stage 1 Hypertensives

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coherent Breathing., Aerobic Exercises.
Who it may be relevant to
Registry conditions: Stage 1 Hypertensives. Basic parameters: 30 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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

Interventions

  • Other Coherent Breathing.
    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.
  • Other Aerobic Exercises
    Aerobic Exercises involving brisk walking, warm up, stepper, static cycling, cool down for a periof of 30 min.

Primary outcome measures

  • Heart Rate (beats per minute) [Time frame: 04 weeks]
  • Systolic Blood Pressure (mmHg) [Time frame: 04 weeks]
  • Diastolic Blood Pressure (mmHg) [Time frame: 04 weeks]
  • Peripheral Oxygen Saturation (SpO₂, %) [Time frame: 04 weeks]
  • Respiratory Rate (breaths/minute) [Time frame: 04 weeks]
  • Rate Pressure Product (HR × SBP) [Time frame: 04 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Foundation University Islamabad — Islamabad

Identifiers

NCT: NCT07573683 · FUCP/CTR/2026/06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗