Coronary Artery Bypass Graft CABGNCT06801314
Effect of Early Mobilization Exercises After Coronary Artery Bypass Graft
A study of Coronary Artery Bypass Graft CABG, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Coronary Artery Bypass Graft CABG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 30 Sep 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
- 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
- Being tested
- aerobic exercise using cycle ergometer in addition to usual care, resisted exercise using weights and dumbbells in addition to usual care, usual care using mobilization and breathing exercise
- Keywords
- CABG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise using cycle ergometer in addition to usual careOther
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 careOther
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 exerciseOther
mobilization and breathing exercise
| Study group | Role | What they receive |
|---|---|---|
| control group (A) usual care | Active comparator | patients in this group will receive usual care including moibilizations and breathing exercise |
| study group (B)aerobic exercise (using cycle ergometer) in addition to usual care | Experimental | Patients in this group will be received usual care and cycle ergometer aerobic exercise Receives: Other: aerobic exercise using cycle ergometer in addition to usual care |
| study group(C)resisted exercise group (using weights and dumbbells) in addition to usual care | Experimental | Patients in this group will be received usual care and resisted exercise Receives: Other: resisted exercise using weights and dumbbells in addition to usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Functional capacity: It will be assessed by 6MWT test. According to the American Thoracic Society,
Measured: at baseline before intervention and 1 week after intervention
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: after 1 week of intervention
- Adherence
Adherence to the intervention was defined as completing at least 75% of the exercises and consultations
Measured: 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.
Measured: after 1 week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Feb 2025
- Primary completion30 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft CABGStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ali Mohamed Awad Allah, Cairo University
- Investigators
- Ahmad Mahdy Ahmad, A.professor, Study director, Cairo UniversityNESREEN G EL_NAHAS, professor, Study chair, Cairo UniversitySara Ali AWAD ALLAH, Assistant professor, Principal investigator, Cairo UniversityAlaa Eldin Abdelaty Bahy, consultant, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801314
- Sponsor's protocol ID
- P.T.REC/012/005234
- Status last verified
- Nov 2025
- First submitted
- 16 Jan 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No