Experimental Study on ALZHIMER

Shreejeet ShresthaMPH(Mahidol University), M.Sc. Medical Microbiology(TU)

BackgroundAlzheimer 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.

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.

Research Title

Exercise plus behavioral management in Patients with

Alzheimer Disease: A randomized Controlled trial

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

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?

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.

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

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.

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 dwellingAmbulatoryHave 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.

Exclusion Criteria

Patients InstitutionalizedUnwilling or unable to continue (Caregiver

and patient)Cannot be contacted

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 trainersBehavior management was also assessed by assignments which were rated by study trainers.The training sessions were videotaped

What are the outcome factors and how are they measures?

Primary Outcome MeasuresPhysical health and functionAffective status

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) scoresSF – 36 (36-item Short-Form Health Survey)SIP Mobility (Sickness Impact Profile)Cornell Depression in Dementia ScaleRestricted Activity days

Secondary Outcome Measurespatient walking speed, functional reach and

standing balance Number of restricted activity daysPatient behavioral disturbance and caregiver

distress

Measurement toolsPatient performance-based and Caregiver-

report assessments on secondary outcome measures.

Revised memory and behavioral problem checklist

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

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

RandomizationComputer program was used for random

allocation sequenceRandomized based on blocked groups of 8

patientsThe patient-caregiver were randomized after

baseline assessment.

Are statistical tests considered?

For demographic and baseline scores◦Fisher exact test◦T-test◦Non parametric Kruskal-Wallis test

Cox proportional hazard

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)

For 5 post-treatment visitsLongitudinal analysisAutoregressive correlation analysis

◦Sensitivity analysis

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

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

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

3 C’s of experimental studyCompliance: Fair/limited

Contamination: Less chances

Co-intervention: May be

Limitation of this study

The used criteria to enroll was established in 1984Information 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.

Additional commentsSample size is not sufficient to assess the

reason to be institutionalizedThey 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

Thank you