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Alternate Nostril Breathing on Cardiorespiratory Functions in Phase 1 Post CABG Patients

Primary Purpose

Post-cardiac Surgery

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Standardized Physical therapy protocol
Alternate nostrils breathing
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-cardiac Surgery focused on measuring Alternate nostril breathing, Cardiorespiratory parameters, Cardiovascular disease, Arterial blood gases, Pulmonary function test

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patient's undergoing CABG surgery.

Exclusion Criteria:

  • With any difficulty in communication.
  • Unstable vital signs
  • Those who are smokers.
  • Other severe complications like diabetes, stroke or cancer.
  • Patient with any respiratory / other pathologies will not be included

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional treatment protocol group

ANB group

Arm Description

Standardized treatment protocol including chest physical therapy as well as limb physical therapy and functional mobility was addressed.

2 sessions per day was added to the standardized treatment protocol

Outcomes

Primary Outcome Measures

Peak expiratory flow rate (PEFR)
Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
Forced vital capacity (FVC)
Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
Forced expiratory volume in 1sec (FEV1)
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
FVC/FEV1
FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
Arterial Blood Gases
An arterial blood gas (ABG) test measures oxygen and carbon dioxide levels in the blood. It also measures body's acid-base (pH) level, which is usually in balance when a person is healthy.

Secondary Outcome Measures

Chest expansion
Chest expansion at xiphoid level measured by finding the difference in measurements during inhalation and exhalation.
Heart rate
Heart rate is measured as part of vitals through heart rate monitor.
Systolic and diastolic blood pressure
Blood pressure is measured through sphygmomanometer
Oxygen Saturation (SPO2)
Oxygen saturation measured through pulse oximeter as part of vitals
Six Minute Walk Test (6MWT)
6MWT is used to assess the functional capacity of patients by calculating the distance covered in a time period of 6 minutes.

Full Information

First Posted
December 15, 2020
Last Updated
March 21, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04674865
Brief Title
Alternate Nostril Breathing on Cardiorespiratory Functions in Phase 1 Post CABG Patients
Official Title
Effects of Anulom-Vilom Pranayama/ Alternate Nostril Breathing on Cardiorespiratory Functions in Phase 1 Post CABG Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (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
No

5. Study Description

Brief Summary
The aim of this study is to investigate effects of Anulom vilom pranayama/ Alternate nasal breathing (ANB) on cardio-respiratory parameters including vitals i.e. heart rate, blood pressure, chest expansion, arterial blood gases (ABGs), pulmonary function test and functional capacity in phase 1 post CABG patients. This study will help Cardiopulmonary physiotherapists to incorporate evidence based protocols for Coronary Artery Bypass Graft Surgery (CABG) in phase 1 of cardiac rehabilitation.
Detailed Description
Breathing is essential function of the body. Learning of breath regulation permits to control body's different mechanisms. "Pranayama" means control of breathing. ANB training consist of mindful breathing. Alternate nostril breathing works on regulating respiratory pattern, improvement of ventilation, clearance of lungs from retaining mucus, decrease in work of breathing and relax the mind and body. Alternate-nostril breathing (ANB) is one type of pranayama that contains inhalation from left side nostril and exhalation by right nostril afterwards inhalation by right nostril and exhalation from left nostril. This technique includes inhalation, exhalation and in advance training retention is also include. Its duration can be vary as depends on person's own capacity. ANB is usually considered to release mental conflict and stimulate mental stability and physical health. There are various studies to evaluate the outcomes of alternate breathing technique on definite functions of cognitive and physiological systems. cardiovascular disorder is the foremost reason of passing away for both gender. Coronary Artery Disease(CAD) is narrowing or obstruction of the arteries/vessels (which deliver nutrients and oxygen to the heart) as a result of atherosclerotic plaque or clot formed in the arteries. 50% patient with CAD showed their first symptoms as cardiac arrest. In western world CAD is the most common root for death. In worldwide, with the risk factors of Smoking, High cholesterol, Hypertension, Diabetes, Emotional stress, Obesity and Sedentary life, each year 3.8 million men & 3.4 million women die due to CAD. Coronary Artery Bypass Grafting(CABG) is most common surgery performed for CAD. This operation can be one week of daily training of Pranayama revealed to induce improvement in the sympathetic tone. Yoga practice along with different breathing exercises improve cardiac output, reduce hepatic, renal blood flow and increases blood flow in cerebral peripheral vessels. Heart rate vary with every single thought and environmental situation. In Anulom - Vilom pranayama, practitioner not only tries to breathe, but at the same moment, retain his focus on the action of breathing, leading to get awareness. This act of attentiveness distract him from tough concerns and evokes relax response. In this stress free state, parasympathetic nerve action supersedes sympathetic nerve's activity lead to noteworthy reduction in systolic blood pressure. Short term training of Anulom vilom pranayama indicated a substantial impact on Systolic Blood Pressure and showed an encouraging outcome on mental and digestive functions. Studies conducted showed that three months Yoga training is highly beneficial for the improvement of blood pressure and heart rate in stage 1 hypertensive patients. Role for ANB in hypertensive people is beneficial to perform focused tasks without sympathetic activation (based on an increased BP). Practice of ANB in Prehypertensive obese young adults for 15 min daily showed a significant improvement in cardiovascular parameters. ANB plays a significant role in improving the various ventilatory functions of lungs, vital capacity and PEFR in pranayama practicing subjects. Increase in VC signifies complete emptying and fullness of air. Blood Pressure and Pulse rate is related with Cardio Vascular System, which is controlled by Autonomous nervous System (ANS). Pranayama accompanied by breath control increases cardiac output, decreases hepatic, renal blood flow and increases cerebral peripheral vessels blood flow. Heart rate varies with single thought and thoughtless condition Blood Pressure and Pulse rate is related with Cardio Vascular System, which is controlled by Autonomous nervous System (ANS). Pranayama accompanied by breath control increases cardiac output, decreases hepatic, renal blood flow and increases cerebral peripheral vessels blood flow. Heart rate varies with single thought and thoughtless condition Blood Pressure and Pulse rate is related with Cardio Vascular System, which is controlled by Autonomous nervous System (ANS). ANB accompanied by breath control increases cardiac output, decreases hepatic, renal blood flow and increases cerebral peripheral vessels blood flow. Heart rate varies with single thought and thoughtless condition Blood Pressure and Pulse rate is related with Cardio Vascular System, which is controlled by Autonomous nervous System (ANS). ANB accompanied by breath control increases cardiac output, decreases hepatic, renal blood flow and increases cerebral peripheral vessels blood flow. Heart rate varies with single thought and thoughtless condition Blood Pressure and Pulse rate is related with Cardio Vascular System, which is controlled by Autonomous nervous System (ANS). ANB accompanied by breath control increases cardiac output, decreases hepatic, renal blood flow and increases cerebral peripheral vessels blood flow. Heart rate varies with single thought and thoughtless condition The worth of physiotherapy skills used for patients after coronary artery bypass surgery (CABG) is well recognized. It is a life-saving process which is usually related with substantial postoperative pain. Various lungs functions may become compromised, or visibly vain, because of severe chest pain and there is frequently chances to develop restrictive lung disease after cardiac surgery. Though painkillers may be effective to diminish the pain but they have side effects which include respiratory depression or respiratory muscles weakness. Hence, development of chemical free approaches for effective pain control is a long standing interest. After Coronary Artery Bypass Grafting (CABG), the quality of life (QOL) is main factor to morbidity and mortality. Adding of Yoga Based Lifestyle Program (YLSP) to cardiac rehabilitation has established a valuable and actual improvement in ejection fraction and decreasing in risk factor profiles. Many studies have been done on the efficacy of this exercise practice in healthy and clinical populations on cardiovascular and the autonomic functions. Numerous investigations have recommended that ANB improves the balance between sympathetic vagal and parasympathetic dominance. Training of ANB after CABG improves chest expansion, peak expiratory flow rate and decrease in pain. ANB along with conventional physiotherapy play a key role in improving Respiratory function and depression issues in CABG patients. Literature reviewed from different search engines has shown that alternate breathing technique has significant positive effects on cardiorespiratory functions but very little literature has been found specifically on phase 1 post CABG studies, regarding to ANB effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-cardiac Surgery
Keywords
Alternate nostril breathing, Cardiorespiratory parameters, Cardiovascular disease, Arterial blood gases, Pulmonary function test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional treatment protocol group
Arm Type
Active Comparator
Arm Description
Standardized treatment protocol including chest physical therapy as well as limb physical therapy and functional mobility was addressed.
Arm Title
ANB group
Arm Type
Experimental
Arm Description
2 sessions per day was added to the standardized treatment protocol
Intervention Type
Other
Intervention Name(s)
Standardized Physical therapy protocol
Intervention Description
Standardized Phase 1 protocol without for 7 days without ANB sessions.
Intervention Type
Other
Intervention Name(s)
Alternate nostrils breathing
Intervention Description
Alternate nostrils breathing 2 sessions per day
Primary Outcome Measure Information:
Title
Peak expiratory flow rate (PEFR)
Description
Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
Time Frame
7 days
Title
Forced vital capacity (FVC)
Description
Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
Time Frame
7 days
Title
Forced expiratory volume in 1sec (FEV1)
Description
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
Time Frame
7 days
Title
FVC/FEV1
Description
FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
Time Frame
7 days
Title
Arterial Blood Gases
Description
An arterial blood gas (ABG) test measures oxygen and carbon dioxide levels in the blood. It also measures body's acid-base (pH) level, which is usually in balance when a person is healthy.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Chest expansion
Description
Chest expansion at xiphoid level measured by finding the difference in measurements during inhalation and exhalation.
Time Frame
7 days
Title
Heart rate
Description
Heart rate is measured as part of vitals through heart rate monitor.
Time Frame
7 days
Title
Systolic and diastolic blood pressure
Description
Blood pressure is measured through sphygmomanometer
Time Frame
7 days
Title
Oxygen Saturation (SPO2)
Description
Oxygen saturation measured through pulse oximeter as part of vitals
Time Frame
7 days
Title
Six Minute Walk Test (6MWT)
Description
6MWT is used to assess the functional capacity of patients by calculating the distance covered in a time period of 6 minutes.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patient's undergoing CABG surgery. Exclusion Criteria: With any difficulty in communication. Unstable vital signs Those who are smokers. Other severe complications like diabetes, stroke or cancer. Patient with any respiratory / other pathologies will not be included
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suman Sheraz, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Rawalpindi
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28122885
Citation
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.
Results Reference
background
PubMed Identifier
25859310
Citation
Shakouri SK, Salekzamani Y, Taghizadieh A, Sabbagh-Jadid H, Soleymani J, Sahebi L, Sahebi R. Effect of respiratory rehabilitation before open cardiac surgery on respiratory function: a randomized clinical trial. J Cardiovasc Thorac Res. 2015;7(1):13-7. doi: 10.15171/jcvtr.2015.03. Epub 2015 Mar 29.
Results Reference
background
PubMed Identifier
25443601
Citation
Raghuram N, Parachuri VR, Swarnagowri MV, Babu S, Chaku R, Kulkarni R, Bhuyan B, Bhargav H, Nagendra HR. Yoga based cardiac rehabilitation after coronary artery bypass surgery: one-year results on LVEF, lipid profile and psychological states--a randomized controlled study. Indian Heart J. 2014 Sep-Oct;66(5):490-502. doi: 10.1016/j.ihj.2014.08.007. Epub 2014 Aug 28.
Results Reference
background
PubMed Identifier
29159176
Citation
Kamath A, Urval RP, Shenoy AK. Effect of Alternate Nostril Breathing Exercise on Experimentally Induced Anxiety in Healthy Volunteers Using the Simulated Public Speaking Model: A Randomized Controlled Pilot Study. Biomed Res Int. 2017;2017:2450670. doi: 10.1155/2017/2450670. Epub 2017 Oct 11.
Results Reference
background
PubMed Identifier
29395894
Citation
Saoji AA, Raghavendra BR, Manjunath NK. Effects of yogic breath regulation: A narrative review of scientific evidence. J Ayurveda Integr Med. 2019 Jan-Mar;10(1):50-58. doi: 10.1016/j.jaim.2017.07.008. Epub 2018 Feb 1.
Results Reference
background
PubMed Identifier
28502461
Citation
Zou Y, Zhao X, Hou YY, Liu T, Wu Q, Huang YH, Wang XH. Meta-Analysis of Effects of Voluntary Slow Breathing Exercises for Control of Heart Rate and Blood Pressure in Patients With Cardiovascular Diseases. Am J Cardiol. 2017 Jul 1;120(1):148-153. doi: 10.1016/j.amjcard.2017.03.247. Epub 2017 Apr 12.
Results Reference
background

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Alternate Nostril Breathing on Cardiorespiratory Functions in Phase 1 Post CABG Patients

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