Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02144480
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2014-05-01
Brief Title:
Efficacy of Early Short-term Training on Thrombogenesis in Patients Following Coronary Bypass Surgery
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Efficacy of Early Short-term Training on Thrombogenesis in Patients Following Coronary Bypass Surgery
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CD62PG CD63G CD40LG 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
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 CD62PG CD63G CD40LG 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
Detailed Description:
Introduction
The American College of CardiologyAmerican Heart Association guidelines suggested that cardiac rehabilitation CR should be offered to all eligible patients after coronary bypass surgery CABG1 However CR use in America is relatively low among Medicare beneficiaries despite convincing evidence of its benefits and recommendations for its use by professional organizations2 This neglect is as well evident in Taiwan Traffic inconvenience and unavailability due to working hours are the common causes There are ways to mend this situation One of them is to develop an early intensive and short-term CR program The current investigation will adopt an early intensive and supervised training for male patients following elective CABG due to old myocardial infarction andor angina pectoris
Meta-analyses of randomized controlled trials have consistently shown that participation in CR programs improves mortality and morbidity outcomes It also benefits cardiopulmonary fitness quality of life lipid profile etc3 Nonetheless research regarding its effect on balance of thrombogenesis at rest or in response to vigorous exercise is either incomplete or controversial
Previous studies found that acute physical exertion may trigger an acute coronary syndrome The relative risk of cardiac events was 2-6 times higher during strenuous physical exertion 6 METs compared with during mild to moderate intensity activities in cardiac patients4 One of the possible explanations for this is that acute physical exertion may acutely change the hemostatic milieu in favor of increased coagulation and activation of platelet5 Available evidence suggests that strenuous exercise in both healthy subjects and in various cardiovascular disease states is associated with activation of platelets and blood coagulation leading to a prothrombotic or hypercoagulable state6 7 Aspirin is ineffective in attenuating enhanced platelet aggregation and activation induced by exercise8
Regular physical exercise is associated with overall reduced risk of primary cardiac arrest4 D Wosornu et al showed that a three-month aerobic training program 3 sessions per week decreased resting fibrinogen concentration9 A meta-analysis showed that an exercise intervention over 2 weeks is associated with reduced inflammatory activity in patients with coronary artery disease CAD C-reactive protein and fibrinogen have provided the strongest evidence10 Platelet activation by strenuous exercise has been studied in 12 physically active and 12 sedentary individuals before and after a standardized treadmill exercise test Among sedentary subjects exercise caused an augmentation of the platelet activation and reactivity In contrast in physically active subjects exercise failed to induce alteration in platelet activation state11 Our previous study identified that moderate-intensity exercise training 60 maximal oxygen consumption for 30 min per day 5 daysweek for 8 weeks reduced resting and strenuous exercise-induced platelet aggregation and platelet adhesion under shear flow in healthy men12 which were accompanied by decreased vWF binding to platelets and expression of P-selectin on platelets13 Accordingly our main research question is that whether the short-term CR program in the current investigation ameliorates hemostatic imbalance at rest and platelet and coagulation activation at maximal stress exercise
This is 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 education reconditioning exercise and early intensive aerobic training at moderate intensity after CABG A submaximal exercise test will be performed for prescription They will receive two training sessions per day and at least 22 sessions in total The CR group will receive usual CR program After intervention the participant will receive a maximal exercise test In addition six-minute walk test generic and disease-specific quality of life will be collected before and after rehabilitation Additional 20 age-matched non-sedentary healthy participants 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 hemorheological profile by coagulation analyzer Mean platelet volume and platelet activation markers platelet-bound CD62PG CD63G CD40LG will be analyzed Various coagulation and fibrinolysis factors will be quantified including PT aPTT fibrinogen thrombin time FVIIIC antithrombin plasminogen antiplasmin anti-Xa and thrombin generation D-Dimer vWF etc
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
Methodology
Participants A prospective study will be performed within the Cardiovascular Ward of Chang Gung Memorial Hospital Linkuo The inclusion criteria is diagnosed CAD and scheduled to receive elective CABG Patients awaiting first-time elective CABG will be invited to participate in the study and enrolled after giving written informed consent Sixty patients will be enrolled Exclusion criteria are musculoskeletal or neurological impairment precluding performance of cycling and walking assessment atrial fibrillation receiving anticoagulation therapy inability to complete questionnaires planned concomitant surgery and a clinical status which requires emergent CABG Additional 20 non-sedentary age-matched healthy subjects without cardiovascular illness will be recruited as the control group Non-sedentary life style is defined as walking more than 25 minutes in average per day according to the National Population Health Surveys of Canada 14
Randomization The patients will be randomized to two treatment groups see Table 1 below following assessment of study eligibility but prior to initial physiotherapy assessment Randomization will be performed by means of random number generator based on their medical chart number Thirty patients will be allocated to receive usual rehabilitation UR 30 to intensive training IT
Intervention protocol Physiotherapy interventions received by the two study groups are documented in Table 1 The IT group will receive physiotherapy twice daily with longer duration and higher intensity After postoperative day5th the training intensity will be prescribed at ventilatory anaerobic threshold VAT based on the submaximal exercise test in which the end point is supra-VAT All physiotherapy interventions will be undertaken by one physiotherapist specifically trained in the education and treatment methods used in the study15-17
Supplemental oxygen will be used for all supervisedassisted walks if resting oxygen saturations is 92 If patients are in sinus tachycardia defined as 120 beatsmin at rest without hemodynamic compromise exercise will be undertaken at a comfortable pace rather than at a moderate or somewhat strong level of perceived exertion Patients will be counseled not to do walking training outside of physiotherapy sessions
All patients will receive outcome assessment including cardiopulmonary exercise test 6-minute-walk quality of life and hemorheological profile at basal and after strenuous exercise Figure 1
The American College of CardiologyAmerican Heart Association guidelines suggested that cardiac rehabilitation CR should be offered to all eligible patients after coronary bypass surgery CABG1 However CR use in America is relatively low among Medicare beneficiaries despite convincing evidence of its benefits and recommendations for its use by professional organizations2 This neglect is as well evident in Taiwan Traffic inconvenience and unavailability due to working hours are the common causes There are ways to mend this situation One of them is to develop an early intensive and short-term CR program The current investigation will adopt an early intensive and supervised training for male patients following elective CABG due to old myocardial infarction andor angina pectoris
Meta-analyses of randomized controlled trials have consistently shown that participation in CR programs improves mortality and morbidity outcomes It also benefits cardiopulmonary fitness quality of life lipid profile etc3 Nonetheless research regarding its effect on balance of thrombogenesis at rest or in response to vigorous exercise is either incomplete or controversial
Previous studies found that acute physical exertion may trigger an acute coronary syndrome The relative risk of cardiac events was 2-6 times higher during strenuous physical exertion 6 METs compared with during mild to moderate intensity activities in cardiac patients4 One of the possible explanations for this is that acute physical exertion may acutely change the hemostatic milieu in favor of increased coagulation and activation of platelet5 Available evidence suggests that strenuous exercise in both healthy subjects and in various cardiovascular disease states is associated with activation of platelets and blood coagulation leading to a prothrombotic or hypercoagulable state6 7 Aspirin is ineffective in attenuating enhanced platelet aggregation and activation induced by exercise8
Regular physical exercise is associated with overall reduced risk of primary cardiac arrest4 D Wosornu et al showed that a three-month aerobic training program 3 sessions per week decreased resting fibrinogen concentration9 A meta-analysis showed that an exercise intervention over 2 weeks is associated with reduced inflammatory activity in patients with coronary artery disease CAD C-reactive protein and fibrinogen have provided the strongest evidence10 Platelet activation by strenuous exercise has been studied in 12 physically active and 12 sedentary individuals before and after a standardized treadmill exercise test Among sedentary subjects exercise caused an augmentation of the platelet activation and reactivity In contrast in physically active subjects exercise failed to induce alteration in platelet activation state11 Our previous study identified that moderate-intensity exercise training 60 maximal oxygen consumption for 30 min per day 5 daysweek for 8 weeks reduced resting and strenuous exercise-induced platelet aggregation and platelet adhesion under shear flow in healthy men12 which were accompanied by decreased vWF binding to platelets and expression of P-selectin on platelets13 Accordingly our main research question is that whether the short-term CR program in the current investigation ameliorates hemostatic imbalance at rest and platelet and coagulation activation at maximal stress exercise
This is 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 education reconditioning exercise and early intensive aerobic training at moderate intensity after CABG A submaximal exercise test will be performed for prescription They will receive two training sessions per day and at least 22 sessions in total The CR group will receive usual CR program After intervention the participant will receive a maximal exercise test In addition six-minute walk test generic and disease-specific quality of life will be collected before and after rehabilitation Additional 20 age-matched non-sedentary healthy participants 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 hemorheological profile by coagulation analyzer Mean platelet volume and platelet activation markers platelet-bound CD62PG CD63G CD40LG will be analyzed Various coagulation and fibrinolysis factors will be quantified including PT aPTT fibrinogen thrombin time FVIIIC antithrombin plasminogen antiplasmin anti-Xa and thrombin generation D-Dimer vWF etc
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
Methodology
Participants A prospective study will be performed within the Cardiovascular Ward of Chang Gung Memorial Hospital Linkuo The inclusion criteria is diagnosed CAD and scheduled to receive elective CABG Patients awaiting first-time elective CABG will be invited to participate in the study and enrolled after giving written informed consent Sixty patients will be enrolled Exclusion criteria are musculoskeletal or neurological impairment precluding performance of cycling and walking assessment atrial fibrillation receiving anticoagulation therapy inability to complete questionnaires planned concomitant surgery and a clinical status which requires emergent CABG Additional 20 non-sedentary age-matched healthy subjects without cardiovascular illness will be recruited as the control group Non-sedentary life style is defined as walking more than 25 minutes in average per day according to the National Population Health Surveys of Canada 14
Randomization The patients will be randomized to two treatment groups see Table 1 below following assessment of study eligibility but prior to initial physiotherapy assessment Randomization will be performed by means of random number generator based on their medical chart number Thirty patients will be allocated to receive usual rehabilitation UR 30 to intensive training IT
Intervention protocol Physiotherapy interventions received by the two study groups are documented in Table 1 The IT group will receive physiotherapy twice daily with longer duration and higher intensity After postoperative day5th the training intensity will be prescribed at ventilatory anaerobic threshold VAT based on the submaximal exercise test in which the end point is supra-VAT All physiotherapy interventions will be undertaken by one physiotherapist specifically trained in the education and treatment methods used in the study15-17
Supplemental oxygen will be used for all supervisedassisted walks if resting oxygen saturations is 92 If patients are in sinus tachycardia defined as 120 beatsmin at rest without hemodynamic compromise exercise will be undertaken at a comfortable pace rather than at a moderate or somewhat strong level of perceived exertion Patients will be counseled not to do walking training outside of physiotherapy sessions
All patients will receive outcome assessment including cardiopulmonary exercise test 6-minute-walk quality of life and hemorheological profile at basal and after strenuous exercise Figure 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None