RA JIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1 Name of the Candidate T.HARSH LATA NAIDU and Address SRINIVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTER, PANDESHWARA, MANGALORE-575001 2 Name of the Institute SRINIVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTER, MANGALORE. 3 Course of Study and MASTER OF PHYSIOTHERAPY (MPT) Subject 2 years Degree Course. “Physiotherapy in Cardio Respiratory Disorders.” 4 Date of Admission 30/04/2011 To Course 5 Title of the Topic “PREVALENCE OF ORTHOSTATIC HYPOTENSION AMONG ELDERLY IN OLD AGE HOMES AND ITS ASSOCIATION WITH COGNITIVE IMPAIRMENT AMONG ELDERLY IN OLD AGE HOMES”

1 6 Brief resume of the intended work: 6.1 Need for the study Orthostatic Hypotension which is a physical finding, not a disease, may be symptomatic or asymptomatic. The American Autonomic Society (AAS) and the American Academy of Neurology (AAN) define orthostatic hypotension as a systolic blood pressure decrease of at least 20mm Hg or diastolic blood pressure decrease of at least 10mm Hg within three minutes of standing up.1

Orthostatic Hypotension has been observed in all age groups, but it occurs more frequently in the elderly, especially in those who are institutionalized and are using multiple medications.2 Older patients show several changes in the complex autonomic regulation of BP as part of the adaptations related to ageing.3

When an adult rises to the standing position, 300 to 800 ml of blood pools in the lower extremities.4,5 This fluid shift produces a decrease in venous return, ventricular filling, cardiac output, and blood pressure.6 This gravity induced drop in blood pressure, detected by arterial baroreceptors in aortic arch and carotid sinus, triggers a compensatory reflex tachycardia and vasoconstriction that restores normotension in the upright position. This compensatory mechanism is termed as baroreflex; it is mediated by afferent and efferent autonomic peripheral nerves and is integrated in autonomic centers in the brain stem.7Aging is associated with impairment of baroreflex. Thus, Orthostatic Hypotension in older patients results from an excessive reduction in blood volume when patients are upright or from inadequate cardiovascular compensation. Maintenance of blood pressure during position change is quite complex; many sensitive cardiac, vascular, neurologic, muscular and neurohumorol responses must occur quickly.5 If any of these responses are abnormal blood pressure and organ perfusion can be 2 reduced. As a result, symptoms of central nervous system hypo perfusion may occur, including feeling of weakness, nausea, headache, neck ache, lightheadedness, dizziness, blurred vision, fatigue, tremulousness, palpitation and impaired cognition.1

Orthostatic Hypotension is also associated with increase in the risk for stroke or brain vascular disease, nocturnal hypertension, myocardial infarction and accelerated atherosclerosis.8,9

Hypotension may result in transient or sustained cerebral hypo perfusion. Hypo perfusion has been suspected to correlate directly with deficits in many cognitive domains including, short-term memory, verbal and visual memory, attention, spelling and abstract thinking.10

Age-related cognitive changes may be linked to frontal lobe dysfunction.11 Orthostatic Hypotension may contribute to frontal brain changes and may exacerbate cognitive decline.12

Systemic hypotension and therefore, possible cerebral hypotension are associated with the presence of white matter lesions13, which in turn are implicated in the pathogenesis of cognitive decline.14 Indeed, several studies suggest that white matter lesions may underlie poor performance on cognitive test.15 It has been postulated that long standing, excessive BP variability in the elderly may impair cerebral perfusion and induce changes, such as lacunes or leukoaraiosis that cause cognitive decline.15,16,17

So, the purpose of this study is to find out the prevalence of orthostatic hypotension as it is a risk factor for cardiovascular diseases and all-cause of mortality, and to determine the cognitive impairment among elderly as it is possible that repeated episodes of hypotension might make vascular dementia symptoms more evident.

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6.2 Review of literature

1. Enrique Asensiol et al (2011) conducted a study on prevalence of orthostatic hypotension among 134 elderly Mexican institutionalized patients. It was observed that orthostatic hypotension was present in 30% of the studied population.3

2. Balapala R kartheek, Ganesan Kumar, S Ameerunnisa Begum, Sivayogi Venkateswaraiah (2011) conducted a study to determine the patterns of orthostatic blood pressure changes, symptoms and clinical factors in different aged groups. The study concluded that orthostatic hypotension incidence increases with increase in age and symptoms are independent of physical recording.18

3. Kathryn M Rose et al (2010) examined the association between orthostatic hypotension (OH) and cognitive function in middle aged adults and concluded that much of the association between asymptomatic orthostatic hypotension and poor cognition among a middle aged healthy population may be due to other known factors.19

4. Shiman Mehrabian et al (2010) determined the relationship between orthostatic hypotension (OH) and cognitive function in elderly subjects with memory complaints and results of the study found that subjects with OH had worse cognitive function than those without orthostatic hypotension.20

4 5. Lena Molander, Yngve Gustafson, Hugo Lovhein (2010) did a study on low blood pressure and its association with cognitive impairment in very old people and concluded that after adjustment for a number of health factors, there was an association between low blood pressure and cognitive impairment.21 6. Germanie C Verwoert et al. (2008) conducted a study to determine the prognostic role of orthostatic hypotension for cardiovascular disease (CVD) and all-cause mortality in elderly people and concluded that orthostatic hypotension increases the risk of CHD and all-cause mortality in elderly people.8

7. Phillip A Low (2007) did a study on prevalence of orthostatic hypotension and concluded that orthostatic hypotension is a dynamic entity, it is frequent, and increases with age and the presence of orthostatic hypotension worsens prognosis and increases mortality.22

8. Hannah C Heims et al (2006) did a study on cognitive functioning in orthostatic hypotension due to pure autonomic failure and documented a moderate incidence of cognitive impairment in patients with pure autonomic failure.23

9. H Luukinen, K Koski, P Laippala and K E J Airaksinen (2004) investigated the prognostic significance of orthostatic hypotension on the risk of myocardial infarction (MI) amongst the elderly and concluded that orthostatic testing offers a novel means to assess the risk

5 of MI amongst elderly persons. Diastolic BP drop immediately after standing up identifies elderly subjects at a high risk of subsequent MI.24

10.Avrahm Weiss, Ehud Grossman, Yichayaou

Beloosesky, Joseph Grinblat (2002) conducted a study on

orthostatic hypotension in acute geriatric ward and

concluded that orthostatic hypotension is very common in

elderly, and Diastolic OH is more common than Systolic

OH.25

6.3 Objectives of the study

 Primary objective: To determine the prevalence of orthostatic hypotension among elderly in old age homes.  Secondary objective: To measure the cognitive impairment among elderly people with orthostatic hypotension.

6.4 Hypothesis:

 Experimental hypothesis:  There will be significant prevalence of the orthostatic hypotension among elderly in old age homes.  There will be a significant association in cognitive impairment among elderly with Orthostatic Hypotension.

6  Null hypothesis:  There will be no significant prevalence of the orthostatic hypotension among elderly in old age homes.  There will be no significant association in cognitive impairment among elderly with Orthostatic Hypotension.

Material and Methods:

7.1 Source of data:

Male and female elderly with the age 60 years and above, who fulfill the inclusion criteria, will be selected for the study. Subjects will be taken from the old age homes.

Sampling : Convenient Sampling

7.2 Method of collection of data:

The study will be consisting of 150 elderly who are 60 and above old. Voluntary participation for the study will be considered. An informed consent will be taken from each participant.

Measurement procedure:

1. Blood Pressure measurement will be recorded as follows:  During supine lying (at least 5min of rest) with Mercury Sphygmomanometer.  Then immediately after sitting, during 1min of standing up and after continue 3min of standing up.  Orthostatic Hypotension will be diagnosed when there will be drop

7 7 in systolic BP equal to or higher than 20mm Hg, a diastolic fall equal to or higher than 10mm Hg, or where there will be combination of both.

2. Mini Mental State Examination will be conducted,  Scores on the MMSE range from 0 to 30  Scores of 25 or higher being traditionally considered normal.  Mild impairment from 19 to 24.  10 to 19 indicate moderate impairment  Below 10 indicate severe impairment.26

Materials to be used:

1) Mercury sphygmomanometer. 2) Minimental State Examination Scale (MMSE)

Inclusion Criteria  Elderly people in old age home.  Age 60 and above old.

Exclusion criteria  Elderly unable to stand for 3min.  Incapable to answer MMSE.

Statistical analysis

Study design: Cross-sectional study.

TEST: Descriptive Statistics, Karl Pearson Correlation Coefficient.

8 7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly. Yes. I intend to measure participant’s blood pressure.

7.4 Has ethical clearance been obtained from your institution in case of 7.3? Yes. Consent has been taken from the Institute ethical committee.

List of References:

1. Consensus statement on the definition of orthostatic hypotension, pure autonomic failure and multiple system atrophy. The consensus committee of the American autonomic society and the American academy of Neurology 1996; 46: 1470.

2. Juan J Figueroa, Jeffrey R Basford, Phillip A Low. Preventing and treating orthostatic hypotension as easy as A,B,C. Cleveland clinic J Med 2010;77(5): 298-306.

3. Enrique Asensio L, Andrea Aguilera C, Maria de los Angeles Corral C, Karla L Mendoza C, Pablo E Nava D, Ana Lila Rendon C, Liliana Villegas C, Juan Manuel Fraga S, Enrique Negrete E, Lilia Castillo M, Arturo Orea T. Prevalence of orthostatic hypotension in a series of elderly Mexican institutionalized patients. Cardiology J 2011;18 (X):XX-XX.

4. Lipsitz LA. Orthostatic hypotension in the elderly. N Engl J Med 1989; 231: 952-7.

9 5. Weling W, Van Lieshout JJ. Maintenance of postural normotension in humans, in low PA clinical autonomic disorders evaluation and management Boston: little brown 1993; 69-77.

6. Sjostrand T. The regulation of the blood distribution in man. Acta Physiol Scand 1952; 26: 312-27.

7. Ziegler MG, Lake CR, KOPIN U. The sympathetic nervous system detect in primary orthostatic hypotension. N Engl J Med 1997; 296: 293-97.

8. Verwoert G, Mattace Raso F, Hofman A. orthostatic hypotension and risk of cardiovascular disease in elderly people: The Rotterdam study. J Am Geriate Soc 2008; 56: 1816-20.

9. Carmona J, Amado P, Vasconcelos N. Does orthostatic hypotension predict the occurrence of nocturnal arterial hypotension in elderly patient? Rev port Cardiol 2003; 22: 607-15.

10.Qir C, Winblad B, Fratiglioni L. The age dependent relation of blood pressure to cognitive function and dementia. Lancent Neuol 2005; 4: 487-99.

11.Levine B, Stuss DT, milberg WP. Effect of aging on conditional associative learning: process analyses and comparision with focal fontal leisions. Neuropsychology 1997;11: 367-81.

12.Siennicki Lantz A, Lilja B, Elmstahl S. Orthostatic hypotension in Alzheimer’s disease: result or cause of brain dysfunction? Aging 1999;11:155-60.

10 13.Passant U, Warkentin S, Gustafson L. Orthostatic hypotension and low blood pressure in organic dementia: a study of prevalence and related r clinical characteristics. Int J Geriatr Psychiatry 1997;12: 395-403.

14.Launer L J Ross GW, Petrovitch H, Masaki K, Foley D, White LR, et al Midlife Blood Pressure and dementia: the Honolulu-Asia aging study. Neurobiol Aging 2000; 21: 49-55.

15.Matsubayashi K, Okumiya K, Wada T, Osaki Y, Fujisawa M, Doi Y et al Postural dysregulation in systolic blood pressure is associated with worsened scoring on neuro behavioral function tests and leukoaraiosis in the older elderly living in a community. Stroke 1997; 28: 2169-73.

16.Ballard C, O’Brien J, Barber B, Scheltens P, Shaw F, McKeith I ,et al Neuro cardiovascular instability, hypotensive episodes and MRI lesions in neuro degenerative dementia. Ann N Y Acad Sci 2000;903:422-5.

17.Hunt A L, Orrison WW, Yeora, Hoaland K Y, Rhyne RL, Garry PJ, et al. Clinical significance of MRI white matter lesions in the elderly. Neurology 1989; 39: 1470-1474.

18.Avraham Weiss, Ehud Grossman, Yichayaou Beloosesky, Joseph Grinblat. Orthostatic hypotension in acute geriatric ward. Arch Intern Med 2002; 162: 2369-74.

19.Hannah C Heims, Hugo D Critchley, Naomi H Martin H, Rolf Jager, Christropher J Mathiasuisa Cipolotti. Cognitive functioning in orthostatic hypotension due to pure autonomic failure. Clin Auton Res 2006; 16: 113-20.

20.Balapala R Kartheek, Ganesan Kumar, S Ameerunnisa Begum,

11 Sivayogi venkateshwaraiah. Postural Changes In Blood Pressure Associated With Ageing Int J Life Sci Pharma Research 2011; 1(1): 88-93.

21.Phillip A Low. Prevalence of orthostatic hypotension. Clin Auton Res, 2008; 18: 8-13.

22.H Luukinen, K Koski, P Laippala and KEJ Airsaksinen. Orthostatic hypotension and the risk of myocardial infarction in the home dwelling elderly. J Int Med, 2004; 255: 486-93.

23.Lena Molander, Yngve Gustafson, Hugo Lovhiem. Low blood pressure is associated with cognitive impairment in very old people. Dement Geriatr Logn Disord 2010; 29: 335-41.

24.Shima Mehrabian. Relationship between orthostatic hypotension and cognitive impairment in the elderly. J Neurol Sci 2010; 299: 45-48.

25.Kathryn M. Rose, orthostatic hypotension and cognitive function: the atherosclerosis risk in communities study. Neuro epidemiology 2010; 34:1-7.

26.Folstein MF, Folstein SE, Mc Hugh PR. “Mini-Mental State”: a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res1975; 12:189-198.

12 9 Signat ure of the c andidate

1 0 Re m arks of t he guide Stu d y is fea s ible to con d u ct

1 1 1 1 .1 Guide ’ nam e and DR. RAMA PRABHU K.R De signatio n As s ocia te Profes s or in Ph ys ioth era p y

1 1 .2 Signature

1 1 .3 Co-Guide nam e and DR. PINKI BHASIN De signatio n As s is ta n t Profes s or in Ph ys ioth era p y

1 1 .4 Signature

1 1 .5 He ad of the DR.T.JOSELEY De partm e nt SUNDERRAJ PANDIAN As s ocia te Profes s or in Ph ys ioth era p y An d P.G Coord in a tor

1 1 .6 Signature

1 2 1 2 .1 Re m arks of Accep ted b y th e Scien tific Chairm an and Princ ipal a n d Eth ica l Com m ittee

1 2 .2 Nam e and Signature

DR. RAMPRASAD M. Prin cipa l a n d Profes s or in p h ys ioth era p y

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