Effect of Early Mobilization Exercises After Coronary Artery Bypass Graft

NCT ID: NCT06801314

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-09-30

Brief Summary

purpose: This study aims to assess the effects of early mobilization exercises guided by wearable technology on functional capacity after coronary artery bypass graft Methods: Patients will be randomly assigned into three groups: Group A will receive usual care, Group B will receive usual care in addition to aerobic exercise, and Group C will receive usual care in addition to resistance exercise. both the aerobic exercise group and the resistance exercise group will be guided by wearable artificial intelligence ECG monitors for real-time support and guidance, and they will stop exercise when any adverse events occur.

Exercises will be started early from post operative CABG until patients discharge and measurements will be taken at baseline and before discharge

Detailed Description

A) Procedure for evaluation and training

Equipment:

The following instruments will be used:

• Pulse oximeter: It will be used for measuring oxygen saturation and Heart rate before, during, and after sessions and during exercise test
• Intelligent cardiac monitor: used during 6MWT to detect any adverse events during and immediately after the test and also be used during sessions
• Rating of perceived exertion: to estimate effort and exertion during the test and working phase.
• Cycle ergometer: upper and lower pedaling machine will be adjusted to suit all patients' height during exercise sessions
• Dumbbells and weights will be used during exercise sessions Exercise (treatment) procedures
• Group (A): (usual care group):

Start early mobilization exercises and deep breathing exercises with wound support daily

• Group (B): (aerobic exercise group): Patients in this group will receive usual care and cycle ergometer aerobic exercise Mood of exercise: continuous aerobic exercise
• Modality of exercise: cycle ergometer with upper and lower pedaling at the same time with adducted shoulders.
• Intensity of exercise: low to moderate intensity and HR (calculated as recommended by the American College of Sports Medicine (ACSM) and tolerated up to 20-30 bpm above the resting HR), BP, SpO2 and low to moderate rate of perceived exertion through the Borg Scale (10-13) will be monitored during cycling
• Duration: 15-20 min, including 5 min warm-up, 5 min cool down and a working phase from 5-10 min
• Frequency: Daily until discharge
• Group (C): (resisted exercise group):

Patients in this group will receive usual care and resisted exercise

• Mode: Resisted exercise
• Modality: dumbbells or sandbags tied around main groups of muscles Resistance exercises consisted of muscle training with dumbbells for the upper limb (UL) (biceps, triceps, and shoulder flexors) and sandbags for the lower limb (LL) (quadriceps, hamstrings, abductors, and calves).

Intensity of exercise: the load that the patient can lift for 10-12 repetitions at RPE of 10-13 and 1-2 sets Both the aerobic exercise group and the resistance exercise group will be guided by wearable artificial intelligence ECG monitors to provide real-time support and guidance and stop exercise when adverse events occur.

Conditions

Coronary Artery Bypass Graft CABG

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group (A) usual care

patients in this group will receive usual care including moibilizations and breathing exercise

Group Type: ACTIVE_COMPARATOR

No interventions assigned to this group

study group (B)aerobic exercise (using cycle ergometer) in addition to usual care

Patients in this group will be received usual care and cycle ergometer aerobic exercise

Group Type: EXPERIMENTAL

aerobic exercise using cycle ergometer in addition to usual care

Intervention Type: OTHER

aerobic exercise group):Patients in this group will be received usual care and cycle ergometer aerobic exercise Mood of exercise: continuous aerobic exercise

• Modality of exercise: cycle ergometer
• Intensity of exercise: low to moderate intensity and HR (calculated as recommended by the American College of Sports Medicine (ACSM) and tolerated up to 20-30 bpm above the resting HR), BP, SpO2 and rate of perceived exertion through the Borg Scale (10-13) will be monitor during cycling
• Duration: 15-20 min including 5 min warm up and 5 min cool down and working phase from 5-10 min
• Frequency: daily until discharge aerobic exercise group guided by wearable artificial intelligence ECG monitor to real-time support, guide and stop exercise when there is any adverse events will occur.

study group(C)resisted exercise group (using weights and dumbbells) in addition to usual care

Patients in this group will be received usual care and resisted exercise

Group Type: EXPERIMENTAL

resisted exercise using weights and dumbbells in addition to usual care

Intervention Type: OTHER

resisted exercise group): Patients in this group will be received usual care and resisted exercise

• Mode: resisted exercise
• Modality: dumbbells or sand bags tied around main groups of muscles for upper and lower limbs Intensity of exercise: the load that the patient can lift for 10-12 repetition at RPE of 10-13 and 1-2 sets resisted exercise group guided by wearable artificial intelligence ECG monitor to real-time support, guided and stop exercise when there is any adverse events will occur.

Interventions

aerobic exercise using cycle ergometer in addition to usual care

aerobic exercise group):Patients in this group will be received usual care and cycle ergometer aerobic exercise Mood of exercise: continuous aerobic exercise

• Modality of exercise: cycle ergometer
• Intensity of exercise: low to moderate intensity and HR (calculated as recommended by the American College of Sports Medicine (ACSM) and tolerated up to 20-30 bpm above the resting HR), BP, SpO2 and rate of perceived exertion through the Borg Scale (10-13) will be monitor during cycling
• Duration: 15-20 min including 5 min warm up and 5 min cool down and working phase from 5-10 min
• Frequency: daily until discharge aerobic exercise group guided by wearable artificial intelligence ECG monitor to real-time support, guide and stop exercise when there is any adverse events will occur.

Intervention Type: OTHER

resisted exercise using weights and dumbbells in addition to usual care

resisted exercise group): Patients in this group will be received usual care and resisted exercise

• Mode: resisted exercise
• Modality: dumbbells or sand bags tied around main groups of muscles for upper and lower limbs Intensity of exercise: the load that the patient can lift for 10-12 repetition at RPE of 10-13 and 1-2 sets resisted exercise group guided by wearable artificial intelligence ECG monitor to real-time support, guided and stop exercise when there is any adverse events will occur.

Intervention Type: OTHER

usual care using mobilization and breathing exercise

mobilization and breathing exercise

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1-post -operative clinically stable patients with hemodynamic stability through measurement of respiratory rate( >8<30) breaths/min , Heart rate (>40<130) beats /min , Spo2>90% 2-both lower limbs will be physically functional 3-CABG surgery 4-Their age will be ranged from 45-65 years old

Exclusion Criteria

1. Respiratory insufficiency after surgery manifesting hypoxemia with partial pressure of oxygen in arterial blood <60 mmHg

2. Cardiogenic shock

3. acute renal failure

4. contra-indicated to submaximal exercise test

5. cardiac arrhythmia

6. locomotor/neurological limitation to ambulation

7. physiological compensatory tachycardia in case of (anemia, high tempreture and infection)

8. high blood pressure at rest (systolic blood pressure >160mmHg or diastolic blood pressure >100 mmHg -

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sara Ali Mohamed Awad Allah

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmad Mahdy Ahmad, A.professor

Role: STUDY_DIRECTOR

Cairo University

NESREEN G EL_NAHAS, professor

Role: STUDY_CHAIR

Cairo University

Sara Ali AWAD ALLAH, Assistant professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Alaa Eldin Abdelaty Bahy, consultant

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of physical therapy, Cairo university

Giza, Egypt, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/005234

Identifier Type: -

Identifier Source: org_study_id