NCT07177989

Brief Summary

Hypertension (HTN) is the foremost preventable risk factor for cardiovascular disease (CVD) and all-cause mortality, contributing to over 7 million deaths annually within the nearly 17 million attributed to CVD. Effective management through lifestyle modifications, including aerobic exercises specifically interval training presents a promising avenue for blood pressure regulation by promoting vasodilation and regulating the autonomic nervous system. Likewise, alternate nostril breathing has demonstrated efficacy in lowering blood pressure by optimizing oxygenation and improving endothelial function but their combined effect on BP measures is yet to be determined. Hence this study aims to determine the combined effects of aerobic interval training with and without alternate nostril breathing on blood pressure, rate pressure product and quality of life in patients with hypertension.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

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 Start

First participant enrolled

January 15, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 10, 2025

Last Update Submit

September 10, 2025

Conditions

Keywords

hypertensionintensity interval trainingnostril breathingheart rateblood pressure

Outcome Measures

Primary Outcomes (3)

  • heart rate

    heart rate will be measured by pulse oximeter

    05 weeks

  • blood pressure

    it will be measured by pulse oximeter

    05 weeks

  • Rate pressure product

    it will be evaluated by formula : systolic blood pressure x heart rate resting by using sphygmomanometer

    05 weeks

Study Arms (2)

Interventional group (Group B)

EXPERIMENTAL

Patients in this group will perform alternative nostril breathing along with aerobic interval training. A protocol of total 5 weeks. Three sessions per week on alternate days will be done under the supervision of physiotherapist. All outcome measurements would be performed first at baseline and terminal after the 5 weeks intervention period

Other: Experimental Group

Interventional group (Group A)

ACTIVE COMPARATOR

Patients in tis group will perform aerobic interval training. A protocol of total 5 weeks. Three sessions per week on alternate days will be done under the supervision of physiotherapist. All outcome measurements would be performed first at baseline and terminal after the 5 weeks intervention period

Other: interventional group A

Interventions

The interventional group will perform aerobic training (stationary cycling) 3 days a week for 5 weeks, starting with 40-60% heart rate reserve (HRR) for 20-30 minutes, with thein the first week and increasing to 40-85% HRR, maintaining a target heart rate of 40-60% HRR at the lower end and 75-85% HRR at the upper end, following a 1:4 work-to-rest ratio for 30-40 minutes in subsequent weeks, with the warm up of 5 mins before the session and a cool down of 5-7 mins after every seasion. Exercise heart rate will be calculated using the Karvonen formula for the base line week and the following weeks.Following each aerobic session, they'll practice Alternate Nostril Breathing (ANB), beginning with 5 minutes in the first week and progressing to 10 minutes thereafter. ANB involves specific hand positioning and breathing techniques to promote relaxation and balance. All sessions will be supervised by a physiotherapist.

Interventional group (Group B)

In interventional group 'A' participants will perform aerobic training for 3 days a week for 30-40 minutes a day for 5 consecutive weeks. Exercise heart rate will be calculated using the Karvonen formula. For the first base line week the aerobic session begins with a 5-minute warm-up. The primary cardiovascular component involves using a cycle ergometer (stationary cycling) at an intensity of 40-60% heart rate reserve (HRR) for 20-30 minutes. Finally, the workout will concludes with a cool-down phase lasting 5-7 minutes, allowing the heart rate to gradually return to baseline and preventing post-exercise hypotension. From the second week onwards, the aerobic training session will begin with a 5-minute warm-up to prepare the body and gradually increase heart rate. The main workout involves a cycle ergometer, maintaining a target heart rate of 40-60% HRR at the lower end and 75-85% HRR at the upper end, following a 1:4 work-to-rest ratio for 30-40 minutes. The session ends with a 5-7 min

Interventional group (Group A)

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 25- 50 years -males and females
  • Patients diagnosed with stage 1 hypertension 130 - 139 / 80 - 89 mmHg and stage 2 hypertension, BP level ≥140/90 mmHg. according to AHA/ACC 2017 Guidelines-Individuals who are able to understand and follow the instructions for exercise

You may not qualify if:

  • Diagnosed with any current infections
  • subjects with diagnosed musculoskeletal or neurological conditions which hinder participation in physical activity program
  • Active Smokers
  • Those with any contraindication to exercise testing or training.
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy, Islamabad, 44000

Rawalpindi, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Zara Khalid, PhD

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 trial having two groups. One group (Group B), will receive alternative nostril breathing along with aerobic interval training and the other group group B) will receive only aerobic interval training.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 17, 2025

Study Start

January 15, 2025

Primary Completion

January 15, 2026

Study Completion

February 15, 2026

Last Updated

September 17, 2025

Record last verified: 2025-09

Locations