FALLS AND PHYSICAL ACTIVITY IN PERSONS WITH MILD TO MODERATE

DEMENTIA PARTICIPATING IN AN INTENSIVE MOTOR TRAINING

RANDOMIZED CONTROLLED TRIAL

Tania Zieschang, MD, Michael Schwenk, PhD,wz

Clemens Becker, MD, PhD, Lorenz Uhlmann,y Peter
Oster, MD, PhD, and Klaus Hauer, PhD

Presented by :
Novaria Puspita, M.D.

Supervised by :
Marietta Shanti P., M.D., Physiatrist

10th Journal Reading

Friday, March 23rd, 2018
• People with dementia have lower levels of physical activity
and motor function compare with older people without
dementia

• Reduced physical activity  diminished muscle mass and

strength, deconditioning, fear of falling, increased fall risk 
reduction of physical activity  additional disability burden

• The benefits of motor training are so overwhelming that

training interventions are widely recommended  as falls
prevention strategy in older people

• The Prevention of Falls Network Europe (Pro-FaNE) published a

consensus statement in which the experts write:

“The desirable profile of an intervention is one that improves

activity and confidence while reducing falling”
• Several recent studies : in older people without cognitive
impairment have confirmed that falls per risk exposure time 
a more relevant and sensitive measure than falls per person-
year and is superior to evaluate intervention effects

• The above results and recommendations  cannot be

extrapolated for people with dementia (have an increased
risk for falls)

• Meta Analysis : Only one of the included RCTs showed a

significant effect of training intervention on fall rate on its own

• A recent review on long-term exercise interventions in

community dwelling older people with dementia included 2
trials with falls as outcome measure  only the study of Pitka¨
la¨ et al showed significant results
to analyse :

The effects of the exercise intervention on falls over a period of 12 months in 2 ways:
used person-years (in primary analysis) and hours of physical activity (in secondary
analysis) as denominators to calculate fall rates and compared the 2 concepts,
which has not yet been done in a study population with dementia
• Double-blinded, Randomized Controlled Intervention Trial
• Neither the testers nor the participants were aware of group identity
• Patients were recruited either consecutively from rehabilitation wards of a geriatric
hospital (AGAPLESION Bethanien Hospital/Centre for Geriatric Medicine at the
University of Heidelberg) at the end of rehabilitation, or from outpatient nursing
care services from 2006 to 2008
 Inclusion Criteria

• A dementia diagnosis in accordance with

international Standards was confirmed in patients
who met the screening criteria for cognitive
impairment (Mini Mental State Examination
MMSE scores 17 to 26)
• Written informed consent; approval by the
treating physician and the legal guardian (if
appointed)
• Aged 65 and older
• Ability to walk 10 m without a walking aid
• No uncontrolled or terminal neurological,
cardiovascular, metabolic, or psychiatric disorder
• Residence within 15 km of the study center
(Reference No. 19)
 Interventions
◦ The patients were randomized in two groups :
1. The Intervention Group
◦ underwent a progressive resistance and functional training for a duration of 3
months (2 hours, twice weekly)
◦ Resistance training in groups of 4 to 6 patients, supervised by a qualified
instructor
◦ Targeted functionally relevant muscle groups at a submaximal Intensity (60% to
80% of the 1-repetition maximum)
◦ The functional training focused on basic activities of daily living– related motor
functions such as keeping balance while standing, walking, stepping, sitting
down

2. The Control Group

◦ Twice weekly for a 1-hour motor placebo group training supervised by the same
qualified instructors
◦ Typical activities were flexibility exercises, calisthenics, low-intensity training with
hand-held weights, and ball games while seated
 Physical activity was assessed :
• Before randomization (T1)
• at the end of the 3-month training period (T2)
• at the short-term follow-up 3 months later (T3)
• at the late term follow-up 9 months after training cessation (T4)

The interview-based physical activity questionnaire for the elderly

• Validated against an objective, accelerometer-based assessment of PA in older persons with

cognitive impairment
• Covers activities of daily living, leisure activities, and exercise
• The hours per week spent in an activity were multiplied with a factor depending on the intensity of
the activity
• The intensity-adapted hours were summarized over all activities of the week
Falls were prospectively recorded over the entire observation period of 12 months
using monthly fall calendars and telephone reminders as recommended by Pro-
FaNE
it was safe to increase physical activity by exercise training in older people with dementia and the fall
rate did not increase

In the high-risk subgroup of multiple fallers  the number of falls per 1000 hours of activity was
significantly reduced

important aspect to be considered is that falls usually have a multifactorial cause and people with
dementia are prone to other risk factors especially adverse drug effects  Future research should
develop and evaluate multifaceted falls prevention interventions customized for people with dementia,
which include drug review, management of postural hypotension, and attention to environment
Physical activity went back to baseline after cessation of the training intervention  shows that a
habitual change was not achieved

This study observed a beneficial effect of exercise training on fall rate during second half year for the
subgroup of multiple fallers

During the first 3 months after training cessation (months, 4 to 6) fall risk seems to
be higher in the intervention group, both in the whole group and for multiple fallers,
whereas in the following 3 months (months, 7 to 9) the number of falls per 1000
hours of activity was reduced in the intervention group  further research should
scrutinize the time frames in which falls occur after initiation of exercise
interventions
The strengths of the study :
• The prospective fall recording over 12 months with falls calendars and telephone reminders per
established guideline
• The analysis of the falls incidence not only per person-years but also adjusted for physical activity,
which has not been done previously in a population with dementia
• The clear case definition including a confirmed diagnosis of dementia, the substantial training
effects that effectively targeted acknowledged high-impact risk factors for falls
• This study was the first study to apply a high-intensity machine-based weightbearing exercise
program in patients with dementia.
The study was not designed and the sample size not calculated for falls incidence as the primary study
endpoint  the data on falls outcomes do not allow confirmatory conclusions but can contribute to meta-
analyses

Although the study used a physical activity questionnaire administered in a semistructured interview, which
was developed for and validated in older persons with and without cognitive impairment, this study may not
completely exclude incomplete reports or recall bias.
The questionnaire covered only the week before the interview and the result was extrapolated to the whole
period of 3 or 6 months

Because of the primary study question of the RCT, the trial was not designed as
a 3-armed study with a usual care control group in addition to the active control
group  this study cannot exclude that falls incidence was higher in both the
intervention group and control group compared with usual care  The results
cannot be generalized to other populations with dementia.
• Reduce the apprehension toward physical activity as falls risk in people
with dementia and confirm that 1 goal of falls prevention interventions is
the promotion of physical activity  Increased physical activity during
exercise intervention was safe in people with mild to moderate dementia
• Falls per risk exposure time seems to be a sensitive and meaningful
additional outcome measure in older people with dementia
9.8%
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
How well was the study done to minimise
bias?
Code as follows:
Taking into account clinical considerations, your
evaluation of the methodology used, and the
statistical power of the study, are you certain that
the overall effect is due to the study intervention?
Are the results of this study directly applicable to
the patient group targeted by this guideline?
High quality (++)
Acceptable (+)
Low quality 
Unacceptable (-)– reject 0 
yes, I am certain
Yes, but it still needs further research with bigger
sample size and needs to examine specific
subpopulations with dementia as falls risk differs
between patients with Alzheimer disease, vascular
dementia, the Parkinson disease with dementia, or
dementia with Lewy bodie
 Reference 39
• Why During the first 3 months after training cessation (months, 4 to 6)
fall risk seems to be higher in the intervention group, both in the whole
group and for multiple fallers
• i) harmful impact of exercise due to fatigue, exercise-induced muscle
soreness or other pain exacerbated by exercise
• ii) increased confidence or exposure to physical activity due to
enhanced mobility
 MMSE
• The Mini–Mental State Examination (MMSE) or Folstein test is a 30-point
questionnaire that is used extensively in clinical and research settings
to measure cognitive impairment1
• It is commonly used in medicine and allied health to screen for
dementia1
• The MMSE is used to screen patients for cognitive impairment, track
changes in cognitive functioning over time, and oftentimes to assess
the effects of therapeutic agents on cognitive function2

1. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the
clinician. Journal of Psychiatric Research. 1975;12(3):189–198.
2. Strauss E, Sherman EMS, Spreen O. A Compendium of Neuropsychological Tests: Administration, norms, and commentary. 3rd ed
Oxford University Press; Oxford: 2006.
Test Features :

Orientation to time

Orientation to place

Registration

Attention and calculation

Recall
Language
Repetition
Complex commands
 Dementia
• It's an overall term that describes a group of symptoms • Alzheimer’s disease is a brain disorder
• Diagnostic and Statistical Manual of Mental Disorders characterized by a progressive dementia that
(DSM) : occurs in middle or late life
• Dementia is the decline of memory and other
• The pathologic characteristics are degeneration
cognitive functions in comparison with the patient’s
previous level of function as determined by a history of specific nerve cells, presence of neuritic
of decline in performance and by abnormalities plaques, and neurofibrillary tangles
noted from clinical examination and
neuropsychological tests
• A diagnosis of dementia cannot be made when
consciousness is impaired by delirium, drowsiness,
stupor, or coma or when other clinical abnormalities
prevent adequate evaluation of mental status
• Types of dementias: Alzheimer disease, vascular
dementia, the Parkinson disease with dementia, or
dementia with Lewy bodies, Frontotemporal
dementia, Mixed dementia
 DEMENTIA STAGES
Clinical Dementia Rating (CDR) Scale
CDR-0 — No dementia
CDR-0.5 — Mild
Memory problems are slight but consistent; some difficulties
with time and problem solving; daily life slightly impaired
CDR-1 Mild
Memory loss moderate, especially for recent events, and
interferes with daily activities. Moderate difficulty with solving
problems; cannot function independently at community affairs;
difficulty with daily activities and hobbies, especially complex
ones.
CDR-2 — Moderate
More profound memory loss, only retaining highly learned
material; disoriented with respect to time and place; lacking
good judgment and difficulty handling problems; little or no
independent function at home; can only do simple chores and
has few interests.
CDR-3 — Severe
Severe memory loss; not oriented with respect to time or place;
no judgment or problem solving abilities; cannot participate in
community affairs outside the home; requires help with all tasks
of daily living and requires help with most personal care. Often
incontinent.
 COGNITIVE FUNCTION
• various cognitive domains such as memory, attention, executive
functions, perception, language, and psychomotor functions (Froestl
et al., 2012)
 Physical

Activity

Questionnaire

for Elderly

(PAQE)
Physical Activity
Questionnaire for
Elderly
(PAQE)
Physical Activity
Questionnaire for
Elderly
(PAQE)
 Table 0: Baseline characteristics of participants who completed fall reporting versus
participants who refused fall reporting

Participants who Participants who

completed fall refused fall
Variable reporting reporting p-value*

(n=110) (n=12)

Years of age, mean (SD) 82.1 (6.6) 87.0 (6.6) 0.029

Gender, % female 73.6 75.0 0.919

• Table 0, MMSE, mean (SD) 21.8 (3.1) 22.1 (1.8) 0.604

Years of education, median (range) 11.0 (7-19) 11.0 (8-15) 0.477

Supplemental CIRS, mean (SD) 24.0 (3.3) 21.9 (2.9) 0.037

• Digital Content 1,
Number of medications, mean (SD) 7.2 (2.9) 5.8 (3.8) 0.217

ADL (median, range) 85.0 (40-100) 80.0 (35-100) 0.988

http://links.lww.com/ GDS, mean (SD) 9.6 (5.9) 10.6 (4.6) 0.477

SF-12 PCS, mean (SD) 37.6 (10.7) 33.1 (11.1) 0.208

WAD/ A168). SF-12 MCS, mean (SD) 49.7 (10.8) 45.0 (12.7) 0.233

FES-I, median (range) 25.0 (16-58) 22.0 [11] (16-50) 0.666

PAQE, median (range) 3.1 [106] (0.1-25.3) 9.5 [5] (3.5-27.4) 0.064

Social status, n (%) 0.979

community dwelling 92 (83.6) 10 (83.3)

institutionalized 18 (16.4) 2 (16.7)

History of falls in past year, n (%) 67 (60.9) 6 [10] (60.0) 0.866

Fall related fracture past 5 years, n (%) 37 (33.6) 2 [10] (20.0) 0.369

1-RM leg press (kg), mean (SD) 147.2 (50.8) 123.8 (54.0) 0.175

5-chair rise (sec), mean (SD) 17.4 (8.3) 18.2 (6.4) 0.696

Walking speed (m/s), mean (SD) 0.93 (0.34) 0.88 (0.38) 0.661

Timed-up-and-go (sec), mean (SD) 16.4 (12.2) 18.0 (8.5) 0.523

MMSE=Mini Mental State Examination25; CIRS=Cumulative Illness Rating Scale28; ADL=Activities of daily Living (Barthel
Index)29; GDS=Geriatric Depression Scale30; SF-12=Short Form Health Survey31; PCS=physical component summary;
MCS=mental component summary; FES-I=Falls Efficacy Scale International32; PAQE=Physical Activity Questionnaire for the
Elderly.33 1-RM=1-Repetition maximum at the leg press, sum of results of both legs separately, 5-chair rise=time needed to