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Completed

NCT Number: NCT06801314

Effect of Early Mobilization Exercises 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

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy, Cairo university

Giza, Egypt, 11432

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Respiratory insufficiency after surgery manifesting hypoxemia with partial pressure of oxygen in arterial blood <60 mmHg
  • Cardiogenic shock
  • acute renal failure
  • contra-indicated to submaximal exercise test
  • cardiac arrhythmia
  • locomotor/neurological limitation to ambulation
  • physiological compensatory tachycardia in case of (anemia, high tempreture and infection)
  • high blood pressure at rest (systolic blood pressure >160mmHg or diastolic blood pressure >100 mmHg -

Treatment and study plan

aerobic exercise using cycle ergometer in addition to usual care

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.

resisted exercise using weights and dumbbells in addition to usual care

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.

usual care using mobilization and breathing exercise

Other

mobilization and breathing exercise

Primary outcomes

  1. Functional capacity

    Time frame: at baseline before intervention and 1 week after intervention

    Functional capacity: It will be assessed by 6MWT test. According to the American Thoracic Society,

Secondary outcomes

  1. Heart rate variability

    Time frame: at baseline before intervention and 1 week after intervention

    Assessed by AI- ECG cardiac monitor to detect variation in time between subsequent heart beats(R-R interval) at base line and before discharge

  2. - Muscle strength

    Time frame: at baseline before intervention and 1 week after intervention

    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

  3. - Kinesiophobia

    Time frame: at baseline before intervention and 1 week after intervention

    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

  4. - Functional independence

    Time frame: at baseline before intervention and 1 week after intervention

    It will be assessed by Barthel index score to ascertain the patients' abilities to perform activities of daily living

  5. - Length of hospital stay

    Time frame: after 1 week of intervention

    is a promising alternative for costs management and efficient consumption of hospital recourses

  6. - Adherence

    Time frame: after 1 week of intervention

    Adherence to the intervention was defined as completing at least 75% of the exercises and consultations

  7. - Patient Safety

    Time frame: after 1 week of intervention

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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