Exercise Training in Patients After Bypass Surgery

NCT05188352 | Completed

• 1 other identifier: BVUsozyilmaz09
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Based on clinical experience both physical condition and psychological recovery after surgery are individually variable. Exercise training plays an important part, has been recommended for CABS patients in order to enhance recovery. Regular exercise following CABS has shown that, in addition to the expected improvements in exercise capacity as a result of the surgery itself, patients who participate in cardiac rehabilitation can expect to see additional gains in exercise capacity and risk factor profiles. Exercise training also increases personal self-esteem and self-confidence, can alleviate depression and fear, and increase the sense of well-being. The aim of this study was to examine the effects of supervised aerobic exercise training on pulmonary function, functional capacity, maximal exercise capacity, and anxiety in patients after coronary artery bypass surgery.

Conditions

Coronary Artery Bypass Surgery

Keywords

coronary artery patients; coronary artery bypass surgery; respiratory muscle strength; oxygen consumption; aerobic exercise; pulmonary function test; maximal exercise test with oxygen consumption

Outcome Measures

Primary Outcomes (3)

• Change from baseline maximum inspiratory pressure at 8 weeks.

  Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks. Respiratory muscle strength was measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MIP measurement is a non-invasive technique.

  [ Time Frame: Eight weeks ]

• Change from baseline maximum expiratory pressure at 8 weeks

  Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks. Respiratory muscle strength was measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MEP measurement is a non-invasive technique.

  [ Time Frame: Eight weeks ]

• Maximal exercise capacity

  The incremantal, symptom-limited cardiopulmonary exercise test (CPET) was used to assess exercise capacity. Symptom-limited maximal exercise test with oxygen consumption measurement (peak VO2) (Minjhard Oxycon-3) on the treadmill using a Modified Bruce protocol.

  [ Time Frame: Eight weeks ]

Secondary Outcomes (10)

• Change from baseline distance covered in six-minute walk test at 8 weeks.

  [ Time Frame: Eight weeks ]

• Change from baseline Forced Vital Capacity (FVC) at 8 weeks

  [ Time Frame: Eight weeks ]

• Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks .

  [ Time Frame: Eight weeks ]

• Change from baseline Forced Expiratory flow from between 25% to 75% of Vital Capacity at 8 weeks.

  [ Time Frame: Eight weeks ]

• Change from baseline anxiety level at 8 weeks.

  [ Time Frame: Eight weeks ]

Study Arms (2)

Training group

EXPERIMENTAL

Patients in the training group received supervised aerobic exercise training on the treadmill with the intensity of 60-75% of maximal VO2 for 40-50 minutes, 3 days a week for 8 weeks. Work-load was gradually increased during the eight-week period. In addition, conventional chest physiotherapy and was instructed to continue their daily physical activity program at home patients in this group.

Other: Chest physiotherapy; Other: Aerobic exercise training

Control group

ACTIVE COMPARATOR

Patients in the control group received no aerobic exercise training but were asked to continue their chest physiotherapy and daily physical activity program at home.

Other: Chest physiotherapy

Interventions

Chest physiotherapy OTHER

The program included diaphragmatic breathing exercises, thoracic expansion exercises, incentive spirometer exercises, and coughing techniques.

Control group; Training group

Aerobic exercise training OTHER

A treadmill was used for aerobic exercise. Training intensity was used at 60-75% of maximal VO2. Each session had a five-minute warm-up and cool-down period. Blood pressure and ECG were recorded during training sessions before exercise, at the third minute of each workload, after exercise, and during each minute of the recovery period.

Training group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male gender,
• CABG surgery performed in the last one month,
• Patients with negative exercise test (on the 30 days after discharge).

You may not qualify if:

• Valve surgery,
• Perioperative myocardial infarction assessed by electrocardiographic (ECG) and creatine kinase isoenzyme changes,
• Postoperative angina, diabetes mellitus, chronic renal failure, unstable angina, intermittent claudication, heart valve dysfunction (moderate or severe), severe cardiac arrhythmias, -Presence of symptoms at rest or with minimal exertion,
• Chronic obstructive pulmonary disease (\>70% FEV1/FVC), and
• Any disorder that might influence exercise performance physically (e.g. severe back pain, history stroke).

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Officials

• Semiramis Özyılmaz, Assoc. Prof.

  Bezmialem Vakif University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 12, 2022

Record last verified: 2021-12