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Clinical Trials/NCT06801314
NCT06801314CompletedNot Applicable

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

Cairo University1 site in 1 country84 target enrollmentStarted: February 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
84
Locations
1
Primary Endpoint
Functional capacity

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

double blinded(participant ,, investigator )

Eligibility Criteria

Ages
45 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts 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

  • •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 -

Arms & Interventions

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

Intervention: aerobic exercise using cycle ergometer in addition to usual care (Other)

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

Intervention: resisted exercise using weights and dumbbells in addition to usual care (Other)

Outcomes

Primary Outcomes

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

  • - Patient Safety(after 1 week of intervention)
  • Heart rate variability(at baseline before intervention and 1 week after intervention)
  • - Muscle strength(at baseline before intervention and 1 week after intervention)
  • - Kinesiophobia(at baseline before intervention and 1 week after intervention)
  • - Functional independence(at baseline before intervention and 1 week after intervention)
  • - Length of hospital stay(after 1 week of intervention)
  • - Adherence(after 1 week of intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sara Ali Mohamed Awad Allah

assistant lecturer

Cairo University

Study Sites (1)

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