Clinical trial NCT06801314: Effect of Early Mobilization Exercises After Coronary Artery Bypass Graft
Official title: Effect of Early Mobilization Exercises Guided by Wearable Technology on Functional Capacity After Coronary Artery Bypass Graft
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Bypass Graft CABG
Keywords: CABG
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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 -

Primary outcomes:
measure: Functional capacity
timeFrame: at baseline before intervention and 1 week after intervention
Secondary outcomes:
measure: Heart rate variability
timeFrame: at baseline before intervention and 1 week after intervention
measure: - Muscle strength
timeFrame: at baseline before intervention and 1 week after intervention
measure: - Kinesiophobia
timeFrame: at baseline before intervention and 1 week after intervention
measure: - Functional independence
timeFrame: at baseline before intervention and 1 week after intervention
measure: - Length of hospital stay
timeFrame: after 1 week of intervention
measure: - Adherence
timeFrame: after 1 week of intervention
measure: - Patient Safety
timeFrame: after 1 week of intervention
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy, Cairo university
Study officials:
affiliation: Cairo University
name: Ahmad Mahdy Ahmad, A.professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: NESREEN G EL_NAHAS, professor
role: STUDY_CHAIR
affiliation: Cairo University
name: Sara Ali AWAD ALLAH, Assistant professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Alaa Eldin Abdelaty Bahy, consultant
role: STUDY_DIRECTOR
References: