Efficacy of Early Short-term Training on Thrombogenesis in Patients Following Coronary Bypass Surgery

NCT02144480 | Completed

• 1 other identifier: 102-3049A3
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Although the benefit of cardiac rehabilitation following coronary artery bypass graft (CABG) is well-established, it is underused. The current investigation will adopt an early, intensive, short-term and supervised aerobic training at moderate-intensity. The inclusion criteria are diagnosed coronary artery disease (CAD) and clinical indication for elective first-time CABG. Regular physical exercise is associated with overall reduced risk of primary cardiac arrest. Previous study demonstrated that moderate-intensity exercise training reduced resting and strenuous exercise-induced activation of platelet and possibly coagulation. Our main research question is that whether the short-term CR program in the present investigation will ameliorate hemostatic imbalance at rest and platelet coagulation activation at maximal stress exercise. This is designed to be a prospective randomized controlled study. Sixty men who are scheduled to receive elective CABG in Chang Gung Memorial Hospital at Linkuo will be enrolled in the study. They will be randomized into two groups: intensive training (IT) and usual rehabilitation (UR). Participants in the IT group will receive intensive aerobic training at moderate intensity after CABG. A submaximal exercise test will be performed for intensity prescription. They will receive two training sessions per day and at least 20 sessions in total. The CR group will receive usual CR program. After intervention, each participant will receive a maximal exercise test. Additionally, six-minute walk test, generic and disease-specific quality of life, will be collected before and after training. Additional 20 age-matched non-sedentary and healthy men without training will be recruited as control group. Venous blood will be sampled three times (before and after rehabilitation and maximal stress test) for the assessment of platelet activation by flow cytometer and activity of coagulation factors. Mean platelet volume, and platelet activation markers (platelet-bound CD62P%G, CD63%G, CD40L%G) will be analyzed. Various coagulation and fibrinolysis factors will be quantified. We hypothesized that this training program will ameliorate the prothrombotic state and attenuate platelet reactivity and coagulation induced by strenuous exercise in patients after CABG. Hopefully, this clinical investigation will establish an early short-term rehabilitation model following CABG and its efficacy for clinical use.

Conditions

Coronary Artery Disease

Keywords

coronary bypass surgery; rehabilitation; exercise training; platelet activation; cardiopulmonary fitness

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary fitness

  before and after rehabilitation platelet activation before and after stress test

  3 days to 4 weeks after coronary bypass

Secondary Outcomes (1)

• platelet activity(composite measure)

  3 days to 4 weeks after coronary bypass

Other Outcomes (1)

• cardiovascular event

  3 weeks ~ 4 weeks s/p CABG

Study Arms (2)

Intensive training

EXPERIMENTAL

intensive aerobic training in moderate intensity day5 postoperatively. 30 minutes per sessions, 2 sessions per day, 10 sessions per week. There will be 20 sessions in total.

Behavioral: Intensive training

traditional training

SHAM COMPARATOR

traditional rehabilitation

Behavioral: traditional training

Interventions

Intensive training BEHAVIORAL

The IT group will receive physiotherapy twice daily with longer duration and higher intensity

Intensive training

traditional training BEHAVIORAL

usual care: conventional rehabilitation

traditional training

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CAD and scheduled to receive elective CABG. Male patients awaiting first-time elective CABG will be invited to participate in the study, and enrolled after giving written informed consent.

You may not qualify if:

• musculoskeletal or neurological impairment precluding performance of cycling and walking assessment
• receiving anticoagulation therapy
• inability to complete questionnaires
• a clinical status which requires emergent CABG
• end-stage renal disease
• peripheral arterial occlusive disease
• untreated life-threatening cardiac arrythmias
• acute heart failure
• uncontrolled hypertension
• advanced atrioventricular block
• acute myocarditis or pericarditis
• acute systemic illness
• intracardiac thrombus
• progressive worsening of exercise tolerance or dyspnea at rest over previous 3-5 days
• significant ischemia during low-intensity exercise (\< 2 metabolic equivalent of tasks,\< 50W)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Linkuo, Taoyuan, 333, Taiwan

Location

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MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Shu-Chun Huang

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 22, 2014
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)