Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-11-08
Brief Title:
Domain-specific Aerobic Exercise Training in Coronary Artery Disease
Sponsor:
Western University Canada
Organization:
Western University Canada
Study Overview
Official Title:
Domain-specific Aerobic Exercise Training in Coronary Artery Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
DOSE-EX-CAD
Brief Summary:
Exercise training in cardiac rehabilitation rehab is a key part of managing a patient with heart disease It has been shown that cardiac patients who increase their aerobic cardio fitness by exercise training live longer have better quality of life and stay out of hospitals more than patients who do not improve their aerobic fitness The more a patient improves their aerobic fitness the greater the benefit But it has been shown that more than half of patients do not improve their aerobic fitness even after participating in cardiac rehab This may be related to how hard patients are asked to train their training intensity The way intensity is chosen in current programs is commonly based on a one-size fits all method that may not consider that different patients have different abilities There are more personalized methods to determine training intensity that exist but these have never been used in cardiac rehab One method divides intensity into three zones zone 1 moderate intensity zone 2 heavy intensity zone 3 very high intensity that are based on when an individuals biological responses to exercise change The purpose of this study is to see if this approach gives better results in terms of changes in aerobic fitness and if training in the different zones makes a difference Three groups of patients will be asked to train for 3 months in one of the three intensity zones Aerobic fitness before and after exercise training will be compared to see which intensity zone results in the largest change
Detailed Description:
105 patients with coronary artery disease will randomized at a ratio of 111 to three months of personalized domain-based and work-matched training in the 1 moderate- 2 heavy- and 3 severe-intensity domains Age and sex-balance between groups will be achieved by stratified-block randomization
After randomization the protocol is split in two The Testing portion includes physiological health and anthropometric assessments acquired at baseline ie week 0 and at weeks 7 and 14 The Training portion includes aerobic exercise training 3x per week on a cycle ergometer
Testing
Testing at weeks 0 7 and 14 will be identical and completed over two days Days 1 and 2
On Day 1 blood will be drawn and analysed for resting plasma glucose cholesterol and lipid profiles Next participants will perform a step-ramp-step test that includes in series a 6-min constant work rate bout at a low-intensity exercise ie 25 W followed by a symptom-limited ramp-incremental test 5-15 Wmin-1 and after 30 min of recovery a 12-min constant-work rate bout of heavy-intensity exercise ie above gas exchange threshold GET but below the respiratory compensation point RCP 40 of peak power output This protocol will provide measures of cardiorespiratory fitness VO2peak GET RCP and be used to identify and establish the work rate ranges associated with the moderate heavy and severe-intensity domains Throughout the exercise protocol participants will wear a 12-lead ECG and facemask from which respired gas fractions flows and volumes will be measured Week 7 tests will be used to adjust training intensity
Day 2 experiments will run 48-96 hours later First participants body composition will be measured by Dual X-ray Absorptiometry Next participants will perform a step-incremental cycle test at 3 individual-specific work rates within each of the moderate- heavy- and severe-intensity domains After a 4 min 10 W baseline participants will complete 10 min of constant-work rate exercise at 85GET ie moderate then 10 min of constant-work rate at 70 of the difference between GET and RCP ie heavy and then cycle for as long as they can at 115RCP ie severe 4-6 minutes At select time points during the protocol arterialized-venous blood will be sampled from a heated dorsal hand vein and immediately analyzed for blood gas and metabolite concentration using a blood gas analyzer After each blood draw participants cardiac output Q will be measured non-invasively by open-circuit acetylene breathing Following exercise participants will be rested supine in a reclining chair and undergo carbon monoxide rebreathing to measure hemoglobin mass and calculate intravascular volumes
Training
Total training duration is 12 weeks weeks 1-6 and 8-13 All aerobic exercise training will be conducted at Western University Gas exchange measurements obtained from the Testing Day 1 will be used to identify each patients target training work rates Exercise prescription for the 3 groups will be work-matched ie equal in kJ relative to moderate-intensity training and prescribed as follows i moderate constant work rate for 50 min at 85GET MOD ii heavy constant work rate for 25-35 min at 70 HVY and iii severe intervals 4 x 4 min on at 115 RCP - 3 min off at 50-70GET HIIT After the training target is established patients will train 3x per week on cycle ergometer in groups as large as 5
Analyses
An ANCOVA with sex and baseline fitness as covariates will be used to compare post-training outcome variables of the RCT The primary outcome measure is VO2peak secondary outcomes measures include VO2 at GET and RCP and tertiary outcome measures include fasting blood lipids and glucose adiposity hematological variables and submaximal and maximal alveolar and deadspace ventilation Q stroke volume and a-vO2diff Initial primary analysis will be according to randomization regardless of adherence for those who complete post-testing intent-to-treat However to assess physiological effects of training intensities a per-protocol analysis will be used in those who meet training adherence criteria
After randomization the protocol is split in two The Testing portion includes physiological health and anthropometric assessments acquired at baseline ie week 0 and at weeks 7 and 14 The Training portion includes aerobic exercise training 3x per week on a cycle ergometer
Testing
Testing at weeks 0 7 and 14 will be identical and completed over two days Days 1 and 2
On Day 1 blood will be drawn and analysed for resting plasma glucose cholesterol and lipid profiles Next participants will perform a step-ramp-step test that includes in series a 6-min constant work rate bout at a low-intensity exercise ie 25 W followed by a symptom-limited ramp-incremental test 5-15 Wmin-1 and after 30 min of recovery a 12-min constant-work rate bout of heavy-intensity exercise ie above gas exchange threshold GET but below the respiratory compensation point RCP 40 of peak power output This protocol will provide measures of cardiorespiratory fitness VO2peak GET RCP and be used to identify and establish the work rate ranges associated with the moderate heavy and severe-intensity domains Throughout the exercise protocol participants will wear a 12-lead ECG and facemask from which respired gas fractions flows and volumes will be measured Week 7 tests will be used to adjust training intensity
Day 2 experiments will run 48-96 hours later First participants body composition will be measured by Dual X-ray Absorptiometry Next participants will perform a step-incremental cycle test at 3 individual-specific work rates within each of the moderate- heavy- and severe-intensity domains After a 4 min 10 W baseline participants will complete 10 min of constant-work rate exercise at 85GET ie moderate then 10 min of constant-work rate at 70 of the difference between GET and RCP ie heavy and then cycle for as long as they can at 115RCP ie severe 4-6 minutes At select time points during the protocol arterialized-venous blood will be sampled from a heated dorsal hand vein and immediately analyzed for blood gas and metabolite concentration using a blood gas analyzer After each blood draw participants cardiac output Q will be measured non-invasively by open-circuit acetylene breathing Following exercise participants will be rested supine in a reclining chair and undergo carbon monoxide rebreathing to measure hemoglobin mass and calculate intravascular volumes
Training
Total training duration is 12 weeks weeks 1-6 and 8-13 All aerobic exercise training will be conducted at Western University Gas exchange measurements obtained from the Testing Day 1 will be used to identify each patients target training work rates Exercise prescription for the 3 groups will be work-matched ie equal in kJ relative to moderate-intensity training and prescribed as follows i moderate constant work rate for 50 min at 85GET MOD ii heavy constant work rate for 25-35 min at 70 HVY and iii severe intervals 4 x 4 min on at 115 RCP - 3 min off at 50-70GET HIIT After the training target is established patients will train 3x per week on cycle ergometer in groups as large as 5
Analyses
An ANCOVA with sex and baseline fitness as covariates will be used to compare post-training outcome variables of the RCT The primary outcome measure is VO2peak secondary outcomes measures include VO2 at GET and RCP and tertiary outcome measures include fasting blood lipids and glucose adiposity hematological variables and submaximal and maximal alveolar and deadspace ventilation Q stroke volume and a-vO2diff Initial primary analysis will be according to randomization regardless of adherence for those who complete post-testing intent-to-treat However to assess physiological effects of training intensities a per-protocol analysis will be used in those who meet training adherence criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None