Comparison of Breathing Exercise for Hypertensive Patients
Primary Purpose
Hypertension
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Slow breathing exercise group
Diaphragmatic breathing exercise group
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Stage 1 hypertension, Diaphragmatic breathing, Slow breathing, Quality of life
Eligibility Criteria
Inclusion Criteria:
- Patient having stage 1 hypertension, Diagnosed after 1 week BP charting
Exclusion Criteria:
- Patients taking antihypertensive medication Patient having comorbidities Smokers and women taking oral contraceptives
Sites / Locations
- Zakir khan shaheed hospital matta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Slow breathing exercise group
Diaphragmatic breathing exercise group
Arm Description
Slow breathing 5-6 breaths/minute, 3 sets of 5 minutes 2 times/day for 4 weeks.
Diaphragmatic breathing, 3 sets of 5 minutes 2 times/day for 4 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Health related Quality of life
Measured through EuroQOL-five-dimensional-three-level (EQ-5D-3L) questionnaire which comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
Full Information
NCT ID
NCT05158569
First Posted
December 13, 2021
Last Updated
September 15, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05158569
Brief Title
Comparison of Breathing Exercise for Hypertensive Patients
Official Title
Effectiveness of Diaphragmatic Breathing vs. Slow Breathing Techniques on Blood Pressure and Health-related Quality of Life in Adults With Stage 1 Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Literature reports that inspiratory muscle training is more effective in reducing Blood Pressure and voluntary diaphragmatic breathing at 10 or 6 breaths per minute for 10 min twice a day for 4 weeks is effective in producing positive outcomes in hypertensive patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Stage 1 hypertension, Diaphragmatic breathing, Slow breathing, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Slow breathing exercise group
Arm Type
Experimental
Arm Description
Slow breathing 5-6 breaths/minute, 3 sets of 5 minutes 2 times/day for 4 weeks.
Arm Title
Diaphragmatic breathing exercise group
Arm Type
Experimental
Arm Description
Diaphragmatic breathing, 3 sets of 5 minutes 2 times/day for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Slow breathing exercise group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Diaphragmatic breathing exercise group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Health related Quality of life
Description
Measured through EuroQOL-five-dimensional-three-level (EQ-5D-3L) questionnaire which comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient having stage 1 hypertension, Diagnosed after 1 week BP charting
Exclusion Criteria:
Patients taking antihypertensive medication Patient having comorbidities Smokers and women taking oral contraceptives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zakir khan shaheed hospital matta
City
Swāt
State/Province
KPK
ZIP/Postal Code
19200
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25804100
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
28626434
Citation
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.
Results Reference
background
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Comparison of Breathing Exercise for Hypertensive Patients
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