Physical Activity and Public Health Columbia SC 16 September 2021 William E Kraus MD What Will I Get Out of This Talk If I am fortunate three things Whats with this Kraus Guy Note Taking ID: 1001006
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1. Issues in the Design of Randomized Controlled Dose Response Intervention Studies in PA and HealthPhysical Activity and Public HealthColumbia, SC16 September 2021William E. Kraus, M.D.
2. What Will I Get Out of This Talk?If I am fortunate, three things!What’s with this Kraus Guy?Note TakingProlonged Sitting
3. Read this Book:The Sense of StructureGeorge D. Gopen
4. Read this Book:Thinking Fast and SlowDaniel KahnemanThe grandfather of Behavioral Economics
5. Why Do We Need Clinical Trials?Three studies where epidemiology has misled—one of which caused significant excess morbidity and mortality, one of which might have:Arrhythmias and sudden cardiac death -> CAST TrialHRT and CVD in post-menopausal women -> HERS, WHI TrialsHomocysteine and CVD risk -> Folate replacement for prevention
6. Standard Components of a Good Clinical TrialRandomized – to address unmeasured confounders at baselineControlled – to address effect of unmeasured confoundersBlinded – to control for treatment and measurement bias, especially in subjective measures
7. Don’t look at the slides …..….. Behind the curtain
8. Special Considerations for Randomized Controlled Exercise or PA Clinical Trials
9. Considerations—PA StudiesWhat is being testedThe gender issueWhen to measure whatThese issues apply to population and cohort studies as well
10. Considerations (1)What is being tested?IntensityAmount; per what periodFrequencyEnergy Expenditure
11. Energy ExpenditureIntensityDuration & Frequency
12. Control Group 50Low-Amount/Moderate Intensity Group44Low-Amount/HighIntensity Group49High-Amount/ HighIntensity Group50STRRIDE Assessments Domains and Tools:Fitness Exercise testingBody composition CT, SkinfoldsInsulin sensitivity IVGTTLipid profile Fasting plasma, NMRFood intake Recall measureshsCRP Fasting plasma, ELISA 3 months Ramp-up6 months Training2 weeks Detraining24h96h2w
13. 335 RandomizedControl Group 73InactivityLow-Amount/Moderate Intensity Group731200 kcal/week or 12 miles/weekat 40-55% VO2 maxLow-Amount/HighIntensity Group1031200 kcal/week or 12 miles/week at 65-80% VO2 max High-Amount/ HighIntensity Group862000 kcal/weekor 20 miles/week at 65-80% VO2 max 6 months Training3 months Ramp-up2 weeks Detraining24h96h2wSTRRIDE
14. STRRIDE - Training ProtocolsProtocol Intensity Amt Min/wk (peak VO2) (kcal/wk) (min per wk)Brisk Walking 13 miles/week 1300 170Jogging 13 miles/week 1300 120Jogging 22 miles/week 2200 170Inactive None None
15. STRRIDE - Training ProtocolsProtocol Intensity Amount/Dose (peak VO2) (kcal/wk) (min per wk)Low/Mod 40-55% 1300 170Low/Vigor 65-80% 1300 120High/Vigor 65-80% 2200 170Inactive None None None
16. Protocol Intensity Amount/Dose (peak VO2) (kcal/wk) (min per wk)Low/Mod 40-55% 1300 170Low/Vigor 65-80% 1300 120High/Vigor 65-80% 2200 170Inactive None None NoneSTRRIDE - Training ProtocolsIntAmtFreq
17. STRRIDE II - Training ProtocolsProtocol Intensity Amount Frequency AT 65-80% VO2 1300kcal 3x per wk RT 3 reps of 12-15 reps 3x per wk AT/RT combination AT/RT 3-5x per wk High AT 65-80% VO2 2200kcal 3x per wk
18. STRRIDE - Training ProtocolsIntensity Amount Presc Wt. Loss (peak VO2) (kcal/wk)Brisk Walking 16 miles/week NoneJogging 16 miles/week NoneBrisk Walking 10 miles/week NoneDPP Program 10 miles/week 7%Diet
19. Considerations (2)The Gender Issue
20. Energy ExpenditureIntensityDuration & Frequency
21. DREWSTRRIDE% VO2 max 50% 40-55% 65-80%DREWSTRRIDENet ∆ % VO2 max (mL/kg/min)Net ∆ VO2 max (L/min)% VO2 max 50% 40-55% 65-80%
22. Considerations (3)What to Measure When Relative to the Last Training Bout
23. -20020406080100120***##Change Si (%) with Exercise TrainingInactiveLow DoseModerateLow DoseVigorousHigh DoseVigorous
24. PrePost4d DT14d DTTime Period2.533.544.555.56ISi UnitsLow/ModerateLow/VigorousHigh Vigorous
25. Comparison of High Amount Vigorous at 9 months toLow Amount Vigorous Exercise at 15 months
26. A Few Words about MoTrPACBig ScienceCollaborationsWork in Progress
27. Reunion Slides
28. Reunion ProtocolSTRRIDE I participants that finished intervention period—drop outs not invited back.10 years following completion invited back for CPX test, blood work, assessment of BP, lipids, FBG, FI, waist circumference and weight, PA in last three months.Comparisons made to pre-intervention assessments.
29. Reunion ResultsLow AmountModerateInactiveLow AmountVigorousHigh AmountVigorousLow AmountModerateInactiveLow AmountVigorousHigh AmountVigorousLow AmountModerateInactiveLow AmountVigorousHigh AmountVigorousLow AmountModerateInactiveLow AmountVigorousHigh AmountVigorous
30. Absolute VO2Low AmountModerateInactiveLow AmountVigorousHigh AmountVigorous
31. Mean Arterial BPLow AmountModerateInactiveLow AmountVigorousHigh AmountVigorous
32. Fasting Plasma InsulinLow AmountModerateInactiveLow AmountVigorousHigh AmountVigorous
33. Minimal WaistLow AmountModerateInactiveLow AmountVigorousHigh AmountVigorous
34. Change in Peak VO2
35.
36. PA at 10 YearsExercise Sessions/Week (Last 3 Months)
37. PA at 10 YearsExercise Sessions/Week (Last 3 Months)NoYes
38. Change MAP controlled PAD MAP controlled for weekly PA Last 3 Mo.Low AmountModerateInactiveLow AmountVigorousHigh AmountVigorous
39. (Additional) Questions?