Effects of Balance Training on Functional Capacity of Patients After Coronary Artery Bypass Grafting Surgery

Effects of Balance Training Post Coronary Artery Bypass Grafting

Background:There are still many gaps in research concerning the effect of balance training on functional capacity of patient after coronary artery bypass graft.

Aims: The purpose of this study was to examine the effect of balance training on patients after coronanry artery bypass graft surgery.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass Graft Surgery(CABG)
• Intervention / Treatment: Combination product: Balance Training

Detailed Description

Methods: Sixty male patients under went CABG with ages 55-65 years Patients were randomly randomized into to two groups equal in number 30 in each group. (Group A: study group, Group B: control group).All patients were thoroughly evaluated one day after extubation and day 6 after operation.

Berg Balance Scale (BBS): is a test used to assess patients functional balance , the sit to stand test(STS) used to asses patients functional capacity and SF36 is questionnaire used to assess quality of life with patients. all of those tests done before and after training sessions with both groups. and compare the length of hospital stay between both groups.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11262
    • National Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Sixty male patients underwent CABG surgery, their age between 55 to 65 years old.
2. All patients were conscious, clinically and medically stable.
3. All patients are ambulant independently.
4. All patients are haemodynamically stable.
5. Good cognition level.
6. All patients are conscious and can perform physical activity.

Exclusion Criteria:

1. Hemodynamic instability.
2. Patients who need re-intubation.
3. Patients on high inotropic supports.
4. Patients with existing pulmonary disease or associated pulmonary complications.
5. Recent MI.
6. Patients who reported too much pain.
7. Neuromuscular disorders.
8. Active hemorrhage and hemoptysis.
9. Poor cognition and mentality.
10. Unstable angina.
11. Decompensated heart failure.
12. Deep vein thrombosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A :( Study group); Underwent balance training and cardiac rehabilitation program for a duration of 25-30 min (total session) at a frequency of three times/week (every other day). The balance training was: a- Functional strength exercise b- Stance exercise c- Transition exercise D-Gait training e- Cardiac rehabilitation program .	Combination product: Balance Training; Balance exercises and cardiac rehabilitation (intervention) for patients for 7 Days, 3 times/week for duration of 25-30 min/ session.; Other Names: cardiac rehabilitation
Active Comparator: Group B (control group); underwent cardiac rehabilitation program only for a duration of 25-30 min (total session) at a frequency of three times/week (day after day). the control group, received cardiac rehabilitation program only.	Combination product: Balance Training; Balance exercises and cardiac rehabilitation (intervention) for patients for 7 Days, 3 times/week for duration of 25-30 min/ session.; Other Names: cardiac rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg balance scale(BBS)	(0 indicating the lowest level ,4 indicating the highest level ) data about balance from BBS index.	7 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sit to stand test(SST)in seconds	represent functional capacity (duration of 5 times sit to stand)	1st day and 7th day
length of hospital stay (in Days)	number of days spent in hospital	from 1st day
SF36 Questionnaire( scores)	Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability	3rd day

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: National Heart Institute, Egypt
• Investigators: Principal Investigator: Hady Balabel, phD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 10, 2023
• Study Completion (Actual): December 10, 2023

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: June 30, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: June 30, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: balance and cabg patients

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: after approval can be shared
• IPD Sharing Time Frame: after 1 month for 12 months
• IPD Sharing Access Criteria: will upload it to the journal of publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No