NCT05058222

Brief Summary

This study will provide the evidence that during the postoperative period deep breathing exercise combined with physical training can positively influence the sleep duration and quality. This study will provide the evidence that during the postoperative period deep breathing exercise combined with physical training can positively influence the sleep duration and quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

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

October 15, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

March 6, 2021

Last Update Submit

January 8, 2022

Conditions

Coronary Artery Bypass Graft

Keywords

Breathing exercisesCoronary artery bypassSleep

Outcome Measures

Primary Outcomes (2)

  • St Mary's Hospital Sleep Questionnaire (SMHSQ)

    To check the quality of sleep over the past 24 hours. This SMH tool was a 14 item multiple choice and short answer instrument which examined individuals' previous nights sleep.

    Baseline

  • St Mary's Hospital Sleep Questionnaire (SMHSQ)

    To check the quality of sleep over the past 24 hours. This SMH tool was a 14 item multiple choice and short answer instrument which examined individuals' previous nights sleep.

    3 week

Study Arms (2)

Deep breathing ex (10 reps) Group

ACTIVE COMPARATOR

The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises.

Other: Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise

Deep breathing ex (30 reps) Group

EXPERIMENTAL

The intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days).

Other: Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise

Interventions

Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths ExerciseOTHER

• The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises.

Deep breathing ex (10 reps) Group
Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths ExerciseOTHER

• The intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days).

Deep breathing ex (30 reps) Group

Eligibility Criteria

Age30 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to read and write
  • Stabilization of vital signs \[blood pressure, pulse, respiration)
  • Patient undergoing OFF Pump Coronary Artery Bypass Graft (CABG) Procedure

You may not qualify if:

  • History of severe mental diseases resulting in hospitalization and drug treatment within the previous 6 months
  • Use any kind of other complementary methods such as massage therapy, aromatherapy, etc. to treat sleep disorders for the previous two weeks
  • History of sleep or respiration disorders and used CNS medications in the night.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed forces Institute of Cardiology

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Officials

  • Anam Aftab, Phd*

    Riphah college of rehabilitation and allied health sciences - Rawalpindi

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 6, 2021

First Posted

September 27, 2021

Study Start

October 15, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)