Application of Mind-body Therapies for End Stage Renal Disease

GurjeetBirdee,M.D.,M.P.H.InternalMedicineandPediatrics

VanderbiltUniversityMedicalCenter

Disclosures

•  Nofinancialconflictsofinteresttoreport

Funding

•  Supportedby– NIH/NCCAM:K23AT006965

Outline

•  Yoga as a biopsychosocial intervention

• Model disease: End-stage renal disease

•  Need for intervention

•  Designing an intervention

•  Pilot-study of intervention

Potential Mechanisms of Mind-Body Practices

Psycho

Bio

Social

Exercise

CogniSve

Breathing

Mood

StressReducSon

HealthBehavior

TherapeuScRelaSonship

Groupeffect

PaSentswithEnd-StageRenalDisease

•  Prevalencein2013:661,648

•  Cost:30.9billiontoMedicare

•  5yearsurvivalrateof35%

•  CVDaccountsforhalfofmortality(USRDS2013ADR)

Traditional Risk Factors • Diabetes • Hypertension • Dyslipidemia • Sedentary Behavior • Smoking

Cardiovascular Disease: • Ischemic Heart Disease • Congestive Heart Failure • Sudden Death

End-stage Renal Disease

NNon-Traditional Risk Factors

• Autonomic Dysfunction • Inflammation • Endothelial Dysfunction • Arterial Stiffness • Malnutrition

DisproporSonateburdenofriskfactors

Otherfactorsassociatedwithhighermortality

� Ageandrace(USRDSADR2010,CharraKidnInt1992,MalliouxClinNeph1994)

� Compliance(UnruhAmJKidDis2005)

� PercepSonofillness(KimmelKidnInt1998)

� PoorphysicalfuncSoning(DeOreoAmJKidDis1997,O’HareAmJofKidDis2003,SietsemaKidnInt2004)

PhysicalfuncSoningamongpaSentswithESRD

� Decreasedcardiorespiratoryfitness� Average60%peakoxgyenuptake(VO2peak)ascomparedtoage-predictedvalues

(BarneaIsrJMedSci1980,MooreMedSciSpEx1993,PainterNephron1986)

� DecreasedphysicalfuncSonwithperformancetesSng� 6-minutewalktest� Gaitspeed� Sit-to-standtest

� Self-reportedphysicalfuncSoning� SF-36

(DeOreoAmJofKidDis1997,HsiehAmJofKidDis2006,JohansenAmJofClinNut2003,Oh-ParkAmJPhysMedRehab2002,PadillaJNephro2008,PainterAmJKidDis2000)

OthercondiSons/symptomsamongpaSentswithESRD

•  FaSgue:60-97%prevalence•  Physiological,psychological,andtreatmentrelated(CardenasNephron1982,JhambAmJKidDis2008,MurtaghAdvChrKidDis2007,WiesbordJAm

SocNeph2005)

•  Musclecramps/wasSng•  Cramps-Intra-dialysis-33-86%•  Cramps-Inter-dialysis-25%

(CanzanelloSemDia1992,ChouJRheum1985,KobrinSemDial2007)

•  Mentalhealthdisorders•  Depression-30%;Anxiety-40%

(MurtaghAdvChKidDis2007,TaskapanNephro2005)

HealthRelatedQualityofLife(HRQOL)

•  Decreasedqualityoflife

•  HRQOLcorrelateswithmorbidityand

mortality(EvansNEJM1985,MapesKidInt2003,MerkusAmJKidDis2000,LopezNephroDialTran2004)

SurveyofCAMUseamongPaSentsonHemodialysis

•  Primaryaims:– DescribeCAMuse,includingmindbodytechniques,amongpaSentsonhemodialysis

– DeterminethewillingnessofpaSentsonhemodialysistolearnmindbodytechniques,parScipateinastudyonintra-dialysismindbodytechniques,andberandomizedforastudyprotocol

Birdee2013EvidBasedCompAltMed

Flowchartforsurvey

Exclude: 16 �  Demented:3 �  Non-english:13

Hemodialysis patients at DaVita Dialysis Center Boston, MA

n=122

Refuse: 17

Include: 89 patients •  Response rate: 89/106 = 84%

PaSentCharacterisScsonHD

Characteristic Frequency (%) Age (years) <35 6 35-49 15 50-64 35 64-79 26 >80 12 Male 53 Race White Black Hispanic Asian

29 61 7 1

Characteristic Frequency (%) Duration on HD (years) < 1 1 2-4 5-9 10-23

5 34 20 9

27 Shift-M-W-F 49 Shift Schedule 1 Morning 2 Aftern 3 Evening

46 36 18

Prevalenceofmind-bodyuseeveramongpaSentsonHD

Importanceofmind-bodyconnecSonforhealth

•  Median:9

•  Inter-QuarSlerange:5

PrevalenceofpaSentsonHDinterestedinmind-body

TranslaSonofMind-bodyforPaSentswithEnd-StageRenalDisease

ToolsofMind-bodyPracSce

• Movemente.g.asanainyoga•  Breathing-parScularlyslow• MeditaSone.g.visualizaSon,mindfulness,bodyscan

•  Other:• Sound• Lifestyle• Philosophy

Traditional Risk Factors

• Diabetes • Hypertension • Sedentary Behavior

Cardiovascular Disease: • Coronary Artery Disease • Congestive Heart Failure

ESRD

NNon-Traditional Risk Factors

• Autonomic Dysfunction • Inflammation

• Endothelial Dysfunction

MBPforCardiovascularDiseases

MBPforothersymptomsandco-morbidcondiSons

� FaSgue(Latha2003,Oken2006,Oken2004,Danhauer2008)

� Musclesoreness/flexibility (Boyle2004)

� DepressionandAnxiety(Kirkwood2005,Pilkington2005)

� Qualityoflifeinchronicdisease� e.g.CHF,MS,cancer,OA,asthma

AdvantagestostudyingpaSentswithESRD

•  MulSpleco-morbidiSesresulSnginchronicsymptomsandpoorqualityoflife

•  Dialysistreatment3Smesaweek/3-4hours

• AcSveintervenSonduringidleSme• Allowsforhigh“dose”ofmind-bodypracSce•  Longitudinalanalysistounderstandclinicaleffectsandmechanisms

YogaProtocolDevelopment

•  Primaryaims:– Developintra-dialysisyogaintervenSonspecificallyforpaSentswithend-stagerenaldiseasethroughexpertconsensus

•  Secondaryaims:– DocumenttradiSonalyogatheoryandmedicalraSonaleforintervenSon

Birdee2014YogaandPhysicalTherapy

Developmentofanintra-dialysisyogaprotocol

•  Yogaprotocoldevelopedthroughexpertconsensus•  3expertyogatherapists• Mind-bodyresearcher

•  Bi-weeklymeeSngsfor6months•  Reviewedby:nephrologists,mind-bodyresearchers,andexpertyogatherapistsinIndia

Intra-dialysisyogaprotocol

• DesignedforpaSentsreceivinghemodialysisinachair

• PracScedduringeachhemodialysissession• TotalpracSceupto60minutes• Nomovementofvascularaccesssite

Intra-dialysisyoga� Asanas(postures)withbreathingtechniques

� SlowmeditaSvemovements� MeditaSonandvisualizaSontechniques� Progressivecourse

� IniSallybreathingtechniques� Progressivedevelopmentofpostures

� CyclicalpracSce� EmphasisonamenSonandbreathingcontrol� ModifiedtoindividualneedsbasedonphysicalandmentalcapaciSes

Week 1

Week 2

Week 3

Week 4&5

Week 6&7

Week 8

Week 9 & 0

Week 11&12

Postures Reclined chair • Hip flexion ü ü ü ü ü ü ü ü• Hip twist ü ü ü ü ü ü ü ü• Anterior arm extension ü ü ü ü ü ü ü ü• Rest ü ü ü ü ü ü ü ü• Hip abduction ü ü ü ü ü ü ü• Knee extension ü ü ü ü ü ü

Upright chair • Knee extension ü ü ü ü ü • Knee extension and foot flexion ü • Arm extension ü ü ü ü• Foot flexion ü ü ü ü• Forward bend ü ü ü ü• Chest expansion ü • Chest expansion and twist ü ü

Breathing/ Inspiratory:Expiratory Ratio • Free observed breath ü ü • Controlled breath/Inspiration<expiration ü ü ü ü ü ü• Cooling breath//Inspiration<expiration ü ü ü ü ü

Meditation • Visualize pleasant moving water ü • Visualize pleasant moving water over body

ü

• Visualize moving water with hand from abdomen to chest, and from chest away from body

ü ü ü ü ü ü

• Visualize water moving with hand into body, up and down body, and then

from chest away from body

ü ü ü ü ü

Intra-dialysisYogaProtocol

RandomizedPilotofIntra-dialysisYogaamongPa6entswithEnd-stageRenalDiseaseBirdee2015JRenNut

Specific aims:

•  Primary:Determinethesafetyandfeasibilityofarandomizedpilotofintra-dialysisyogawithusualcareversususualcarealoneamongpaSentswithESRD

•  Secondary:Collectpreliminarydataontheeffectsofintra-dialysisyogaondiseasespecificqualityoflifeandotherself-reportedmeasures.

StudyDesign:RandomizaSon•  Subjectswillberandomizedbysiteto:

– AcSveintervenSon:12-weekIntra-dialysisyogaprotocol

– ComparisonintervenSon:12-weekKidneySchool

•  Method:– Treatmentassignmentsgeneratedbyrandomnumbergeneratorandassignmentsplacedinsealedopaqueenvelopes.

AcSveIntervenSon:Intra-dialysisYoga

•  Classesavailable3xweek

•  Duringthefirsttwohoursofdialysis

•  Yogateacher:4cerSfiedyogateachers

•  Usualcareasperdialysiscenterandnephrologist

ControlIntervenSon:UsualCare

•  KidneySchool-12weeks– Givenweeklyhandouts– Encouragedtocompletematerialsduringdialysis– DividedinamempttomatchyogaintervenSonforSme

– Assignmentsencouraged

OutcomesMeasuringandTesSng:� Primary

� SafetyandFeasibility� Secondary

� Baseline,6week,and12week�  HRQOL�  FaSgue� Mood�  SaSsfacSonwithdialysis�  Sleepquality

� Longitudinalmeasures(over12-weekperiod)�  Bloodpressure(pre-dialysisandpost-dialysis)

Outcomes:Secondary

Instrument Measure Items

KidneyDiseaseQualityofLife-36 HRQOL 36

FuncSonalAssessmentofChronicIllnessandTherapy-FaSgue

FaSgue 33

ProfileofMoodStates Mood 65

PaSentHealthQuesSonnaire9 Depressivesymptoms

9

ESRD:PaSentSaSsfacSon SaSsfacSonTx 6

PimsburghSleepQualityIndex Sleep 17

Randomizedbysiteandshin

Screened(n=73)

Eligible(n=56)

Yoga(n=31) EducaSon(n=22)

Declined(n=8)Declined(n=13)

Enrolled(n=13)Enrolled(n=18)

Completed(n=13) Completed(n=13)

Withdrawal(n=5)Switchedshin(n=3)Notinterested(n=2)

Withdrawal(n=0)

Characteris6cs Yoga KidneySchoolGender,(n)MaleFemale

1367

1385

RaceWhiteBlackOther

1120

1120

Age(years) 49(35-61.5) 48(32-58)Weight(kg) 78.61(68.31-102.29) 89.56(71.22-106.20)Height(m) 1.65(1.58-1.71) 1.80(1.69-1.84)BMI(kg/m2) 28.00(24.00-36.40) 31.40(23.85-34.70)ComorbidiSesHTNCHFDiabetes

1203

1133

Results

•  Feasibility– 77%ofpaSentswereeligible–  65%ofallsubjectsinterested

– Yoga:63%– EducaSon:64%

– CompleSon:74%– Yoga:72%(89%excludingshinchanges)– EducaSon:100%

-Losttofollow-up:1subjectinyogaarm

Results:Feasibility

Yoga,median

TotalpotenSalpracScesessions

32.5(28.00-34.25)

TotalpracScedsessions 20.5(14.75-27.50)

ParScipaSonfrequency(%) 0.70(0.52-0.88)

YogadoseTotalover12weeksPerdialysissession

407minutes

22minutespersession

Results:FeasibilityReasonsfornotprac6cing Yoga,frequency(%)

Injury 0

FaSgue: 22(19%)

NV 8(7%)

Anxiety: 1(0.9%)

InterferencewithpaSentcare

0

MedicalComplicaSons: 2(1.7%)

PaSentRefusal: 21(18.26%)

Absencefromdialysis: 23  (20%)

Other: 38(33%)

PreliminaryResults:Safety

•  NoseriousadverseeventswereobservedinacSveintervenSongrouprelatedtotheintervenSonover12-weekstudyperiod

•  Non-seriousadverseeventswereobservedthatwererelatedtoyogapracSce– Lightheadedness– Soremuscles

PaSentnarraSve1“Sheexplainedthenewfoundawarenessoftheexperienceoftensioninherbody…duringdialysis,othermedicalprocedures,andthroughoutvariousdailyac\vi\es.Shesharedthatthebreathingexerciseshadbeenhelpfultoheroutsideofmedicalse^ngsaswell.Uponexperiencingthedeathofaveryclosefamilymemberandthesubsequenttension-provokingsitua\ons(e.g.,familyinterac\ons,phonecalls,funeralarrangements)thataroseasaresult,thepa\entfoundherselfu\lizingandbenefi^ngfromsomeofthebreathingprac\cesshehadlearnedthroughthestudy.Sheevenfoundherselftobemoreawareofthefeelingsofothersand,thus,beaerabletocomfortthem”

PaSentnarraSve2•  Uponaskingthepa\entwhatkindofdayhewashaving,it

becameveryapparentthathewaseagertobedonewithdialysis.Heexpressedhisfeelingsof\redness,hunger,andreadinesstogo.Thepa\ent’sgeneralimpressionoftheyogaprac\ceswasthatitwas“agoodthing.”Headmiaedthathesome\mesdreadedtheyoga,yethehasfoundtheprac\cestobehelpfulwhenheisfeeling“heavy-chested”orwhenhisbreathingis“outofwhack.”Thepa\entalsoexplainedthathetypicallyfeelsbadwhenheisindialysis;concentra\ngonbreathinghelpshimshiehisfocusfromthese,mostly,nega\veexperiences.

PaSentnarraSve3Thepa\entrespondedtothefirstques\onbysta\ng,“It’sgood.”WhenIpromptedhertoelaborate,sheaddedthatsheissome\mesunabletodotheprac\cesbecauseofs\ffnessinherlegs;however,sheadmiaedfeelingbeaerregularlyaeerdoingtheprac\ces.Inthispa\ent’sopinion,thedura\onoftheprac\cessome\messeemstolasta“lialetoolong”.

PaSentnarraSve4•  Thispa\entindicatedthatshewasnothavingaverygood

day.Shespontaneouslyofferedupascalingresponseof“eight,”indica\ngthatonascaleofonetoten(onebeinggood,tenbeingbad)shewassignificantlyclosertothe“feelingbad”side.Thepa\entindicatedthatshethoughttheyogaprac\ceswerea“goodidea.”Sheexperiencedtheprac\cesas“comfor\ng”and“relaxing.”Shealsoindicatedthattheyhelpher“relievepressure.”Sheexpressedthateveryoneshoulddoyogaprac\ces.Thispa\entlikesthewaytheinstructortalks.Theprac\ceshelpherfeelbeaer.Aeerward,shefeelslikeshehasaccomplishedsomething.Thepa\entalsoindicatedthattheyogaprac\cesgiveher\metothinkaboutthingsshewouldnotnormallythinkabout.

LimitaSons

•  Subjectsswitchingshins•  DifficulttogrouppaSentstogether

•  ComplexpaSentpopulaSon•  ComplexintervenSon

Nextstep

LargerRCT(n=68)–  Enrollmentcompleted–  IntervenSonstobecompleted11/2016–  Outcomeassessmentstobecompleted2/2017

Summary

•  Mind-bodyisnoveltherapythatpaSentsinESRDmayconsider

•  Preliminaryresultsofintra-dialysisyogasuggesthighsafetyprofileandfeasibilitywithhighadherence

ACKNOWLEDGEMENTS

VUMC• RussellRothman• AlpIkizler

YogaTeachers• BeccaBroughton• AdrianaHermel• AndyCoppola

YogaExperts•  ChaseBossart• DolphiWertenbaker,M.D.

• AmyWheeler,Ph.D.•  YogaasTherapyinNorthAmerica