NCT05736770

Brief Summary

To compare the effects of conventional preoperative respiratory rehabilitation and specific preoperative respiratory rehabilitation program on pulmonary functions in coronary artery bypass graft patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

January 13, 2023

Last Update Submit

August 31, 2023

Conditions

Respiratory Rehabilitation

Outcome Measures

Primary Outcomes (3)

  • Forced expiratory volume in one second (FEV1)

    The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The normal test values range between 80% and 120% of the average (predicted) values.

    4th postoperative day of coronary artery bypass graft (CABG)

  • Forced Vital Capacity (FVC)

    Forced Vital Capacity measures the total volume of air that you were able to blow forcefully into the mouthpiece following a full inhalation

    4th postoperative day of coronary artery bypass graft (CABG)

  • Ratio of Forced expiratory volume in 1 second and Forced Vital Capacity (FEV1/FVC)

    FEV1/FVC: The FEV1/FVC Ratio (FEV1%) parameter is calculated by dividing the measured FEV1 value by the measured FVC value. In healthy adults of the same gender, height, and age, the normal Predicted percentage should be between 70% and 85.

    4th postoperative day of coronary artery bypass graft (CABG)

Secondary Outcomes (2)

  • 6-minute walk test (6MWT)

    4th postoperative day of coronary artery bypass graft (CABG)

  • Borg scale

    4th postoperative day of coronary artery bypass graft (CABG)

Study Arms (2)

Respiratory rehabilitation and out of bed mobilization group

EXPERIMENTAL

The Respiratory rehabilitation and out of bed mobilization group will perform 4 exercises.

Other: Respiratory rehabilitation and out of bed mobilization

Conventional exercise program group

ACTIVE COMPARATOR

The conventional exercises program will perform conventional exercises

Other: conventional treatment

Interventions

Respiratory rehabilitation and out of bed mobilizationOTHER

The Respiratory rehabilitation and out of bed mobilization group will perform following exercises: pre operative out of bed mobilization, active cycle breathing techniques, forced expiratory technique and volume based incentive spirometery

Respiratory rehabilitation and out of bed mobilization group
conventional treatmentOTHER

The conventional exercise program group will perform :Flow based Incentive spirometery, Chest percussion if needed

Conventional exercise program group

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing elective Coronary Artery Bypass Grafting (CABG) surgery for Triple vessel coronary artery disease (TVCAD), double vessel coronary artery disease (DVCAD), single vessel coronary artery disease (SVCAD) and left main stem (LMS) disease.
  • Patients who cover at least 400 steps on 6-minute walk test.
  • Patients with ejection fraction 45% or more

You may not qualify if:

  • Acute ailments i.e., patient's cardiac condition deteriorating.
  • Cardiac emergency (shock, acute MI)
  • Presence of neurological disorders e.g., altered state of consciousness, paralysis.
  • Redo surgeries
  • Any musculoskeletal disorder e.g., amputation of limb, problems of balance and risks of fall, muscles weakness grade 3 or less, osteoporosis; leading to limitation in exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad ali awan

Rawalpindi, Punjab Province, Pakistan

Location

Study Officials

  • Muhammad Ali Awan, MS-CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 21, 2023

Study Start

March 15, 2023

Primary Completion

June 10, 2023

Study Completion

August 21, 2023

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)