Experimental study on Alzhimer's Presentation

1. Experimental Study on ALZHIMER
Shreejeet Shrestha
MPH(Mahidol University), M.Sc.
Medical Microbiology(TU)

2. Background
 Alzheimer disease is one of most common form of
dementia. There is no cure for the disease. It’s a
progressive disease.
 Alzheimer patients shows higher risk of fall down,
fracture and more rapid decline on mobility.

3.  Some research indicated that dementia patients are
likely to get depressive and exercise reduces
depression.
 Until this study, some hospital-based exercise
program for Alzheimer disease was conducted.

4. Research Title
Exercise plus behavioral management in Patients with
Alzheimer Disease: A randomized Controlled trial

5.  Methods
◦ Study type
 Experimental study(RCT)
 Conclusion
◦ Exercise training combined with teaching caregivers
behavior management techniques improved physical
health and depression in patients with Alzheimer

6. What is the research question(s) and/or hypothesis?
 Research question
◦ Whether a home-based exercise program combined with
caregiver training in behavioral management techniques
would reduce functional dependence and delay
institutionalization among patients with Alzheimer disease or
not?

7. Hypothesis
◦ Patients in the Reducing Disability in Alzheimer Disease
(RDAD) program would show significant improvement
on measures of physical frailty and depression and
reduce institutionalization compared with those obtained
among patients in the routine care group.

8. Who is the reference population?
 381 patients assessed for eligibility of this study
 228 were excluded:
◦ 144 not eligible
◦ 74 refused participation
◦ 10 not able to contact

9. Who is the sample?
 153 community-dwelling patients meeting National
Institute of Neurological and Communicative
Diseases and Stroke/Alzheimer Disease and
Related Disorders Association criteria for Alzheimer
disease, conducted between June 1994 and April
1999.

10. Inclusion criteria
 Patients meeting the criteria for Alzheimer Disease
from the National Institute of Neurological and Communicative Diseases
and Stroke/Alzheimer Disease and Related Disorders Association
 Community dwelling
 Ambulatory
 Have a caregiver willing to participate in the training
sessions
 Caregiver (spouses or adult relatives) spending a
minimum of 4 hours every day with the patient.

11. Exclusion Criteria
 Patients Institutionalized
 Unwilling or unable to continue (Caregiver and
patient)
 Cannot be contacted

12. What are the study factors (exposures) and
how are they measures?
 Exposure:
12 hour long sessions on exercise training to patient-caregiver
and behavior management training to
caregivers given in first three months of the study
 Measurement:
Exercise compliance was assessed using daily exercise
log by caregivers and exercise homework completed by
trainers
Behavior management was also assessed by
assignments which were rated by study trainers.
The training sessions were videotaped

13. What are the outcome factors and how are
they measures?
Primary Outcome Measures
 Physical health and function
 Affective status

14. Measurement tools
RDAD compared to Routine medical care for Baseline,
3 month, 6 month, 12 month,18 month, 24 month in
the following Mean (SD) scores
 SF – 36 (36-item Short-Form Health Survey)
 SIP Mobility (Sickness Impact Profile)
 Cornell Depression in Dementia Scale
 Restricted Activity days

15. Secondary Outcome Measures
 patient walking speed, functional reach and standing
balance
 Number of restricted activity days
 Patient behavioral disturbance and caregiver
distress

16. Measurement tools
 Patient performance-based and Caregiver-report
assessments on secondary outcome measures.
 Revised memory and behavioral problem checklist

17. What important confounders are
considered?
 Possible confounder(age, sex, MMSE, duration of
dementia) were considered in this study.
 The below factors should be included;
◦ Attitude and motivations of caregivers
◦ Living conditions in houses conducive to exercise
◦ Social economic factor

18. What are the sampling frame and
sampling method?
 Sampling Frame: Community Based Alzheimer
Disease patient registry and patients referred from
physician practices and community advertisements
 No information about specific place where this study
was conducted
 No description to calculate the sample size

19. Randomization
 Computer program was used for random allocation
sequence
 Randomized based on blocked groups of 8 patients
 The patient-caregiver were randomized after
baseline assessment.

20. Are statistical tests considered?
For demographic and baseline scores
◦ Fisher exact test
◦ T-test
◦ Non parametric Kruskal-Wallis test
 Cox proportional hazard

21. For comparison between pre and post treatment
 Primary analysis
◦ Linear, logistic, Poisson regression based on Intention to
treat (ITT) analysis
◦ Sensitivity analysis
 Secondary analysis
◦ Kruskal-Wallis test (conducted as nonparametric)

22. For 5 post-treatment visits
 Longitudinal analysis
 Autoregressive correlation analysis
◦ Sensitivity analysis

23. What do main findings mean?
 Home based exercise program would reduce
functional dependence regarding to SF-36, Cornell
Depression scale, number of restricted activity at 3
months
 Only the difference of SF-36 was maintained and
the difference of SIP mobility appeared at 24
months.
 However, this intervention does not delay the
institutionalization of patients

24. What are the public health implication of the
results?
 Home based exercise and management program
might improve physical health for long time and
mental status for short period.
 Repeated training might maintain the effect of this
program
 The combination of Behavior management and
exercise did improve physical condition, but the
effect of each intervention is unclear

25. Are ethical issues considered?
 Informed Consent was obtained from both patients
and caregivers.
 Ethical approval was obtained from Institutional
Review Board of University of Washington and
Group Health Cooperative

26. 3 C’s of experimental study
 Compliance: Fair/limited
 Contamination: Less chances
 Co-intervention: May be

27. Limitation of this study
 The used criteria to enroll was established in 1984
 Information bias is vital
◦ Care givers have to judge the physical ability of patients,
and mental situation
◦ The negative emotion of care givers to patients affect the
outcome
 More care giver trained under intervention became
sick than those not trained. Should they consider the
side effect of this intervention to this fact.

28. Additional comments
 Sample size is not sufficient to assess the reason to
be institutionalized
 They did not compare the effect of this home-based
intervention with hospital based intervention.
 The criteria used to diagnose AD is too old to apply
this study into present practice
 Non participant information not provided

29. Thank you