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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06801314
Enrollment
84
Registered
2025-01-30
Start date
2025-02-01
Completion date
2025-09-30
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Graft CABG

Keywords

CABG

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.

Interventions

OTHERaerobic 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.

OTHERresisted 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.

OTHERusual care using mobilization and breathing exercise

mobilization and breathing exercise

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double blinded(participant ,, investigator )

Intervention model description

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 resisted exercise

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frameDescription
Functional capacityat baseline before intervention and 1 week after interventionFunctional capacity: It will be assessed by 6MWT test. According to the American Thoracic Society,

Secondary

MeasureTime frameDescription
Heart rate variabilityat baseline before intervention and 1 week after interventionAssessed by AI- ECG cardiac monitor to detect variation in time between subsequent heart beats(R-R interval) at base line and before discharge
- Muscle strengthat baseline before intervention and 1 week after interventionIt 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
- Kinesiophobiaat baseline before intervention and 1 week after interventionIt 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
- Functional independenceat baseline before intervention and 1 week after interventionIt will be assessed by Barthel index score to ascertain the patients' abilities to perform activities of daily living
- Length of hospital stayafter 1 week of interventionis a promising alternative for costs management and efficient consumption of hospital recourses
- Adherenceafter 1 week of interventionAdherence to the intervention was defined as completing at least 75% of the exercises and consultations
- Patient Safetyafter 1 week of interventionPatient 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026