NCT04674865

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

December 15, 2020

Last Update Submit

March 21, 2021

Conditions

Keywords

Alternate nostril breathingCardiorespiratory parametersCardiovascular diseaseArterial blood gasesPulmonary function test

Outcome Measures

Primary Outcomes (5)

  • 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.

    7 days

  • 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.

    7 days

  • 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.

    7 days

  • 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).

    7 days

  • 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.

    7 days

Secondary Outcomes (5)

  • Chest expansion

    7 days

  • Heart rate

    7 days

  • Systolic and diastolic blood pressure

    7 days

  • Oxygen Saturation (SPO2)

    7 days

  • Six Minute Walk Test (6MWT)

    7 days

Study Arms (2)

Conventional treatment protocol group

ACTIVE COMPARATOR

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

Other: Standardized Physical therapy protocol

ANB group

EXPERIMENTAL

2 sessions per day was added to the standardized treatment protocol

Other: Alternate nostrils breathing

Interventions

Standardized Phase 1 protocol without for 7 days without ANB sessions.

Conventional treatment protocol group

Alternate nostrils breathing 2 sessions per day

ANB group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patient's undergoing CABG surgery.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Rawalpindi, Federal, 44000, Pakistan

Location

Related Publications (6)

  • 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. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

    PMID: 28122885BACKGROUND
  • 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.

    PMID: 25859310BACKGROUND
  • 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.

    PMID: 25443601BACKGROUND
  • 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.

    PMID: 29159176BACKGROUND
  • 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.

    PMID: 29395894BACKGROUND
  • 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.

    PMID: 28502461BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 19, 2020

Study Start

September 25, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations