The aim of this study will be to compare the effects of diaphragmatic breathing exercise and active cycle of breathing technique in lowering heart rate and blood pressure measured in hypertensive patients at 24 hour and 7 days interval.
Design
Two parallel groups, single blinded, randomized clinical trial with pre and post assessment
Settings and conduct
DHQ hospital Sahiwal and privately at Sahiwal Diabetes Care Center and Polyclinic (Sahiwal), Participant will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Patients with age range 45-65 years
• Patients clinically diagnosed with hypertension
• Patients who will give consent to abide by treatment for 4 weeks.
Exclusion criteria
• History of precious surgery
• History of rib fracture
• Any neurological problem
• Pregnant females
• Patients with respiratory disease
• Patients with coronary artery disease
Intervention groups
Interventional Group1 : Diaphragmatic breathing exercise.
Interventional Group 2 : Active cycle of breathing technique.
Main outcome variables
• Heart rate
• Systolic and diastolic blood pressure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201024049129N1
Registration date:2021-08-18, 1400/05/27
Registration timing:retrospective
Last update:2021-08-18, 1400/05/27
Update count:0
Registration date
2021-08-18, 1400/05/27
Registrant information
Name
Khazima Asif
Name of organization / entity
Riphah
Country
Pakistan
Phone
+92 46 3709214
Email address
khazimaasif73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-14, 1399/12/24
Expected recruitment end date
2021-06-13, 1400/03/23
Actual recruitment start date
2021-04-20, 1400/01/31
Actual recruitment end date
2021-07-18, 1400/04/27
Trial completion date
2021-07-18, 1400/04/27
Scientific title
Comparison of diaphragmatic breathing exercise and active cycle of breathing technique on heart rate and blood pressure in patients with hypertension
Public title
Effect of diaphragmatic breathing exercise on heart rate and blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age range 45-65 years
Patients clinically diagnosed with hypertension
Patients who will give consent to abide by treatment for 4 weeks.
Exclusion criteria:
History of precious surgery
History of rib fracture
Any neurological problem
Patients with respiratory disease
Patients with coronary artery disease
Pregnant females
Age
From 45 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
44
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group by simple lottery method. Odd and even numbers will be given to group A and B respectively. if a patient gets odd no he/she will be allocated in Group A. If a patient gets Even number he/she will be allocated in Group B. Total sample size will be 40. So, 20 patients will get even number and 20 will get odd number.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be blinded in terms of group allocation. Written Consent will be taken from patients but they will not be informed about the group in which they will be treated and the effects of treatment in each groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Name of ethics commitee: Riphah college of rehabilitation and Allied Health Sciences.
Street address
13-14-C civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Approval date
2021-01-04, 1399/10/15
Ethics committee reference number
RCRS-RE-MS-PT/Fall20/061
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
RO3.0
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Systolic and Diastolic Blood Pressure
Timepoint
Pre Intervention and Post Intervention for all 4 weeks
Method of measurement
Mercury Spygmomanometer
Secondary outcomes
1
Description
Heart rate
Timepoint
Pre intervention and post intervention at the end of each day for 4 weeks.
Method of measurement
By pulse oximeter in minutes
Intervention groups
1
Description
Intervention group 1: Diaphragmatic Breathing Exercise : Patiemt will be in semi fowler position. Therapist will place one hand on rectus abdominis below anterior costal.margin. After patient understand and is able to breath using diaphragmatic pattern,suggest the patient to breath nose and through mouth. Control expiration for 4 or 5 times per session. Each session will be given for 7 days per week (4 weeks).
Category
Treatment - Other
2
Description
Intervention group 2: Active cycle of breathing technique: This technique involves 3 parts. Breathing control in which patient will breath out gently and will be 3 to 5 deeper breaths with 2 second hold at the end of breath in before breath out. Second part is thoracic expansion exn exercise in which patient will keep hia shoulder and chest relaxed and will take a long slow deep breath in through nose. Patient will hold air in lungs for 2-3 seconds before breathing out. And the 3rd part huffing exhaling through open mouth . The session will last for 15 minutes for 7 days per week(4weeks).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah college of rehabilitation and Allied Health Sciences
Full name of responsible person
Khazima Asif
Street address
13-14-C- civic center near hamdard chowk lahore
City
Lahore
Postal code
54000
Phone
+92 40 4505180
Email
khazimaasif73@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International university
Full name of responsible person
Wajeeha
Street address
13-14-C civic center, township near hamdard chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Grant name
Educational
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International university
Proportion provided by this source
15
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Khazima Asif
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation and research
Street address
Ganj shaker colony Alama anwar ul hasan road near swat agro chemical sahiwal
City
Sahiwal
Province
Punjab
Postal code
57000
Phone
+92 334 4886859
Email
khazimaasif73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International university
Full name of responsible person
Wajeeha
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Rehabilitation and Research
Street address
47 Tufail road cantt Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 323 4500788
Email
wajeeha_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rehabilitation and Research
Full name of responsible person
Khazima Asif
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation and Research
Street address
Ganj shaker colony Alama anwar ul haq road near swat afro chemicals, Sahiwal
City
Sahiwal
Province
Punjab
Postal code
57000
Phone
+92 334 4886859
Email
khazimaasif73@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available