Effectiveness of Early Cardiac Rehabilitation

NCT06116773 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-12-11

No results posted yet for this study

Summary

The goal of this experimental study is to compare the effects of early (2nd week) cardiac rehabilitation applied in addition to usual care on functional capacity, quality of life, frailty and body composition in patients undergoing coronary artery bypass graft surgery.

The main questions it aims to answer are:

* Does early cardiac rehabilitation contribute to increasing functional capacity?
* Does early cardiac rehabilitation have positive effects on quality of life, frailty and body composition?

Participants will be divided into 2 groups (n = 50) in a randomized controlled manner. Patients in the training group (n:25) will participate in an 8-week supervised cardiac rehabilitation program as an outpatient after discharge. Patients in the control group (n:25) will be provided with usual care after discharge.

The control group will be informed about secondary prevention approaches and a home-based exercise program will be recommended. In addition to secondary prevention approaches and home-based exercise program, the training group will receive 3 sessions/week, 60 minutes of supervised cardiac rehabilitation for 8 weeks. All patients will be evaluated at baseline and after 8 weeks.

Researchers will compare training and control groups to see if effects on functional capacity, quality of life, frailty, body composition

Conditions

Interventions

OTHER

Training

Training group is supervised exercise group and will be included in a supervised cardiac rehabilitation program for 3 days a week. The program will start 2 weeks after CABG surgery and continue for 8 weeks, totaling 24 sessions. Aerobic, resistance, balance and stretching exercises will be applied within the program. Total exercise time is aimed to be ≥150 min/week for 8 weeks. A home-based exercise program will be recommended. Moderate-intensity continuous aerobic training will be implemented using an upright exercise bike (5 minutes warm-up, 20 minutes load, 5 minutes cool down, 5 minutes recovery). Rhythmic unloaded aerobic exercises or low-load (0.5-1 kg) resistance exercises (starting from the 6th week post-op) will be performed for an average of 15-20 minutes. Balance exercises will progress from easy to difficult depending on the person's performance. Stretching exercise for the gastrocnemius muscle will be performed for 4 repetitions in a short stretching period of 15 seconds.

OTHER

Control

Patients will be informed about secondary prevention approaches which is routinely performed after discharge after CABG operation and will be recommended a home-based exercise program. Patients will be called by phone once a week and exercise monitoring will be provided. Recommended home exercise program includes: * Breathing exercises * Moderate intensity (RPE 4-6) walking (150 min/week). * Posture exercises (shoulder elevation-depression, 90 degree shoulder flex-extend, 90 degree shoulder abd-add, neck joint range of motion exercises) * They will be advised to continue range of motion exercises in the early post-operative period. (Twice a day, 10 repetitions).These exercises include ankle dorsi-plantar flexion, hip abduction-adduction, hip internal-external rotation, hip flexion-extension, arm elevation-depression in the supine position; flexion-extension in the sitting position; hip abduction-adduction, hip hyperextension and counting movements in the standing position.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Rengin Demir, Prof · Istanbul University - Cerrahpasa

  • Raziye Ceylan, MSc · Istanbul University - Cerrahpasa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-07-01
Completion
2025-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06116773 on ClinicalTrials.gov