NCT05158569

Brief Summary

To determine the Effectiveness of diaphragmatic breathing vs. slow breathing techniques on blood pressure and Quality of life in adults with stage 1 hypertension. In accessible literature limited data was found on the comparison of different breathing techniques. The current study will compare the effect of slow vs. diaphragmatic breathing exercises and will demonstrate which one is more effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

November 15, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

December 13, 2021

Last Update Submit

September 15, 2022

Conditions

Keywords

Stage 1 hypertensionDiaphragmatic breathingSlow breathingQuality of life

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Blood pressure is measured in millimeters of mercury (mm Hg). A blood pressure measurement has two numbers: The top number (systolic) is the pressure of the blood flow when your heart muscle contracts, pumping blood. The bottom number (diastolic) is the pressure measured between heartbeats. The patients are classified according to the range as follows. Hypertension stage 1 SYSTOLIC (mm of Hg): 121-139 DIASTOLIC (mm of Hg): 81-89

    4 weeks

Secondary Outcomes (1)

  • Health related Quality of life

    4 weeks

Study Arms (2)

Slow breathing exercise group

EXPERIMENTAL

Slow breathing 5-6 breaths/minute, 3 sets of 5 minutes 2 times/day for 4 weeks.

Other: Slow breathing exercise group

Diaphragmatic breathing exercise group

EXPERIMENTAL

Diaphragmatic breathing, 3 sets of 5 minutes 2 times/day for 4 weeks.

Other: Diaphragmatic breathing exercise group

Interventions

The patient will be first asked to close one nostril with a thumb and slowly breathe in completely through the other for 6 seconds. This nostril will be then closed and the patient will exhale through the other nostril over a period of 6 seconds. These steps complete one breathing cycle. An attempt will be made to keep the breathing rate is about 5-6 breaths per minute. Such alternate nostril breathing cycles will be repeated continuously for a period of about 15 minutes (3 sets of 5 minutes) in one sitting.

Slow breathing exercise group

Patients would be instructed to Sit or lie down in a comfortable place and put their hands on their belly. Relax the muscles in their neck and shoulders. Breathe in slowly through the nose, keeping their mouth closed. Feel the lungs fill with air and inflate like a balloon while their belly moves outward. Such breathing cycles will be repeated continuously for a period of about 15 (3 sets of 5 minutes) minutes in one sitting.

Diaphragmatic breathing exercise group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient having stage 1 hypertension, Diagnosed after 1 week BP charting

You may not qualify if:

  • Patients taking antihypertensive medication Patient having comorbidities Smokers and women taking oral contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zakir khan shaheed hospital matta

Swāt, KPK, 19200, Pakistan

Location

Related Publications (3)

  • Jones CU, Sangthong B, Pachirat O, Jones DA. Slow breathing training reduces resting blood pressure and the pressure responses to exercise. Physiol Res. 2015;64(5):673-82. doi: 10.33549/physiolres.932950. Epub 2015 Mar 24.

    PMID: 25804100BACKGROUND
  • Janet SK, Mangala Gowri P. Effectiveness of deep breathing exercise on blood pressure among patients with hypertension. Int J Pharma Bio Sci 2017; 8(1):B256-60.

    BACKGROUND
  • Ma X, Yue ZQ, Gong ZQ, Zhang H, Duan NY, Shi YT, Wei GX, Li YF. The Effect of Diaphragmatic Breathing on Attention, Negative Affect and Stress in Healthy Adults. Front Psychol. 2017 Jun 6;8:874. doi: 10.3389/fpsyg.2017.00874. eCollection 2017.

    PMID: 28626434BACKGROUND

MeSH Terms

Conditions

HypertensionHypoventilation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRespiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mehwish Waseem, MSPT(CPPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

December 15, 2021

Study Start

November 15, 2021

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations