NCT07573683

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Feb 2026May 2026

Study Start

First participant enrolled

February 28, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 21, 2026

Last Update Submit

May 1, 2026

Conditions

Keywords

Stage 1 HypertensivesBreathingAerobic ExercisesCardiopulmonary parametersCoherent breathing techniqueQuality of life

Outcome Measures

Primary Outcomes (6)

  • Heart Rate (beats per minute)

    Measured using calibrated digital monitor after 5 minutes rest at baseline and post-intervention.

    04 weeks

  • Systolic Blood Pressure (mmHg)

    Measured using standardized sphygmomanometer at baseline and post-intervention.

    04 weeks

  • Diastolic Blood Pressure (mmHg)

    Measured using standardized sphygmomanometer at baseline and post-intervention.

    04 weeks

  • Peripheral Oxygen Saturation (SpO₂, %)

    Measured using pulse oximeter under resting conditions at baseline and post-intervention.

    04 weeks

  • Respiratory Rate (breaths/minute)

    Measured by direct observation at baseline and post-intervention.

    04 weeks

  • Rate Pressure Product (HR × SBP)

    Calculated from heart rate and systolic blood pressure at baseline and post-intervention as an index of myocardial workload.

    04 weeks

Study Arms (2)

Aerobic Exercises

ACTIVE COMPARATOR

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.

Other: Aerobic Exercises

Aerobic Exercises with coherent breathing

EXPERIMENTAL

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

Other: Coherent Breathing.

Interventions

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.

Aerobic Exercises with coherent breathing

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

Aerobic Exercises

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Pakistan

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Kainat Zahra, MSPT-CPPT

CONTACT

Syeda Sumaira Batool, MSPT-CPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled studies involving two groups. Control group will perform only aerobic exercises. Interventional group will perform both coherent breathing and aerobic exercises.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 7, 2026

Study Start

February 28, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2026

Last Updated

May 7, 2026

Record last verified: 2026-04

Locations