NCT06801314

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

January 16, 2025

Last Update Submit

November 21, 2025

Conditions

Keywords

CABG

Outcome Measures

Primary Outcomes (1)

  • Functional capacity

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

    at baseline before intervention and 1 week after intervention

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (3)

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

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

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

Interventions

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.

study group (B)aerobic exercise (using cycle ergometer) 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.

study group(C)resisted exercise group (using weights and dumbbells) in addition to usual care

mobilization and breathing exercise

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, Cairo university

Giza, Egypt, 11432, Egypt

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Ahmad Mahdy Ahmad, A.professor

    Cairo University

    STUDY DIRECTOR
  • NESREEN G EL_NAHAS, professor

    Cairo University

    STUDY CHAIR
  • Sara Ali AWAD ALLAH, Assistant professor

    Cairo University

    PRINCIPAL INVESTIGATOR
  • Alaa Eldin Abdelaty Bahy, consultant

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blinded(participant ,, investigator )
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 30, 2025

Study Start

February 1, 2025

Primary Completion

August 30, 2025

Study Completion

September 30, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations