Effect of Early Mobilization Exercises After Coronary Artery Bypass Graft

Effect of Early Mobilization Exercises Guided by Wearable Technology on Functional Capacity After Coronary Artery Bypass Graft

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass Graft CABG
• Intervention / Treatment: Other: usual care using mobilization and breathing exercise; Other: aerobic exercise using cycle ergometer in addition to usual care; Other: resisted exercise using weights and dumbbells in addition to usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Egypt
    • Giza, Egypt, Egypt, 11432
      • Faculty of physical therapy, Cairo University

Participation Criteria

Eligibility Criteria

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

Description

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 -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group (A) usual care; patients in this group will receive usual care including moibilizations and breathing exercise	Other: usual care using mobilization and breathing exercise; mobilization and breathing exercise
Experimental: 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	Other: 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.
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	Functional capacity: It will be assessed by 6MWT test. According to the American Thoracic Society,	at baseline before intervention and 1 week after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability	Assessed by AI- ECG cardiac monitor to detect variation in time between subsequent heart beats(R-R interval) at base line and before discharge	at baseline before intervention and 1 week after intervention
- Muscle strength	It will be assessed by chair stand test by patient standing /sitting with arms crossed at the wrists against the chest, the numbers of stands in 30s is recorded	at baseline before intervention and 1 week after intervention
- Kinesiophobia	It will be assessed by Tampa Scale 11 (TSK-11) 11-item, 2-factor structure best fit the data. The first factor, somatic focus, consisted of 5 items, while the second factor, activity avoidance, was comprised of 6 items	at baseline before intervention and 1 week after intervention
- Functional independence	It will be assessed by Barthel index score to ascertain the patients' abilities to perform activities of daily living	at baseline before intervention and 1 week after intervention
- Length of hospital stay	is a promising alternative for costs management and efficient consumption of hospital recourses	after 1 week of intervention
- Adherence	Adherence to the intervention was defined as completing at least 75% of the exercises and consultations	after 1 week of intervention
- Patient Safety	Patient safety ( the exercise session will be terminated if any adverse events or arrhythmia occur in patients, which leads to a change in ECG waves in the mobile screen ) eg: Atrial fibrillation causes the absence of the p-wave and a narrow QRS complex.	after 1 week of intervention

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Ahmad Mahdy Ahmad, A.professor, Cairo University; Study Chair: NESREEN G EL_NAHAS, professor, Cairo University; Principal Investigator: Sara Ali AWAD ALLAH, Assistant professor, Cairo University; Study Director: Alaa Eldin Abdelaty Bahy, consultant, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): January 30, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: CABG
• Additional Relevant MeSH Terms: Therapeutics; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Breathing Exercises
• Other Study ID Numbers: P.T.REC/012/005234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No