JOURNAL CLUB

SHUBHAM K.
Part 1

Title of the article Effects of a 16-week multimodal exercise

program on gait performance in individuals
with dementia: a multicenter randomized
controlled trial

Name of Journal BMC Geriatrics

Journal Impact Factor 6.1

H index 89

Gunning fog index 17.11

Author of Affiliation

Year of Publication 2020

Type of Study Randomized Controlled Trial
PART-2 INTRODUCTION /BACKGROUND

Gait impairments represent a major public health concern [1]. Their prevalence increases with
age, and more than 32% of individuals aged 60 years and above have
gait impairments [2] such as decreased walking speed,shortened stride length, and enhanced
double support phase [1, 3, 4]. Gait impairments are very prevalent in individuals with dementia
(IWD), with an estimated 50% of IWD being affected [5, 6]. In contrast, among cognitively
unimpaired older adults, the prevalence rates range between 7 and 36% [2, 5, 6]. Dementia is an
umbrella term for conditions that are characterized by a significant decline in one or more
cognitive domains and behavioral changes that interfere with independence in everyday activities
[7]. The causes of dementia can vary,
with Alzheimer’s disease being the most common in older adults. Other dementias include
vascular dementia, Lewy body dementia, or frontotemporal dementia. Furthermore, mixed
dementia is common
PART-2 INTRODUCTION/BACKGROUND

Various other motor impairments, such as reduced strength and postural control,
may contribute to the increased prevalence of gait impairments in IWD [5, 9].
Moreover, gait is not merely an automated motor activity but requires input from
the cerebellum, the motorcortex, and the basal ganglia, as well as an intact
sensory feedback [1, 10, 11]. Thus, dementia-related pathological changes in
these brain structures may also contribute to gait impairments [3]. Both gait and
cognitive impairments are associated with an increased risk of falls and
decreased quality of life [12,13]. Accordingly, the incidence of falls in IWD is two
to three times higher than in cognitively unimpaired older individuals.
PART-3 METHODS/STUDY DESIGN

Setting of the study Patients diagnosed with dementia and above 65

( where and who are the years of age in Germany from 36 care facilities.
participants?)

Inclusion criteria 1. persons with dememtia as diagonsed with ICD-

10 criteria MMSE performance.
2. Alzheimers disease, vascular dementia, or other
primary dementia

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PART-3 METHODS/STUDY DESIGN

Inclusion criteria 3. mild to moderate severity of dementia ( MMSE

score 10-24)
4. age above 65 and walking ability of about 10
meters.

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PART-3 METHODS/STUDY DESIGN

Exclusion 1. secondary dementia

criteria 2. other sever cogenitive impairement
3. sever motor impairement

Primary GAITRite ( an electronic gait analysis system )

outcome

Secondary MMSE score, 30’s chair stand test ( 30’s CST )

outcome

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PART-3 METHODS/STUDY DESIGN

Statistical/Analytical Statistical analysis was performed using IBM SPSS Version 25 (IBM Corporation,
Approach: Armonk, USA). We ran a perprotocol analysis including participants who had a
MEP adherence of at least 75% (only in IG) and a complete assessment of
spatiotemporal gait parameters in at least one condition of the gait assessment
using GAITRite (i.e. single or two dual task conditions). Additionally, we
implemented an intention-to-treat analysis and used multiple imputation (fully
conditional specification imputation method, ten imputations, and ten iterations) to
account for missing data. However, we did not impute data of deceased
participants. To ensure plausibility of imputed data in the intention-to-treat analysis,
we defined the following constraints: gait performance as both outcome and
predictor variable, adherence to the MEP as well as related motor and cognitive
performance.

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PART-3 METHODS/STUDY DESIGN

Statistical/Analytical minimum and maximum values according to observed range in each variable;
Approach: rounding according to original data; and 100 maximal case draws, ten maximal
parameter draws. We considered pooled results as provided by SPSS or reported
ranges observed throughout the imputations, if SPSS did not support the pooling
procedure, as final point estimates.
Required assumptions were tested before performing statistical analyses. For
comparison of baseline values and sample characteristics between IG and CG, we
used Chi-square tests, Mann-Whitney-U-Tests, and unpaired T-Tests according
to the scaling of the investigated outcome. We analyzed treatment effects using
two-factor ANOVA with repeated measurements (time*group effects), and
supplemented paired T-Tests (within grouptime effects).

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PART-4 RESULTS

Final study population: Total 405 Patients above 65 age group.

Total excluded and five patients, due to reason like injury during (4) study and death(1)
why?

Baseline characteristics Subjects allocated to group A control group (n=118), allocated to group B
of population intervention group(n=201)
(balanced? Significant
There was no baseline difference in all the parameters in both groups.
differences?)

Summary of outcome: A power analysis (G*Power 3, Version 3.1.9.2 [55], two factor analysis of variance
(ANOVA) with repeated measurements, two groups, two measurements, α = 0.05, 1β =
0.80, η2 = 0.01) revealed a required total sample size of 200 participants. Considering
various potential reasons for dropout, missing data, and low adherence to the MEP, we
set the sample size to 405 participants. Participants were recruited from 36 care facilities
in South-Western Germany that had been contacted by the research team and asked
whether they would be interested to participate in the study.
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PART-4 RESULTS

Summary of the relevant Yes both

tables or figures:

Author conclusion: Multimodal exercise program improves gait

performance and fall prevention, in individuals
with dementia.

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Critical Appraisal for
RCT
CONSORT Checklist

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SECTION ITEM CHECKLIST
TITLE AND ABSTRACT 1a. Identification as a randomized trial in the title. 1a. Mentioned

1b. Structured summary of trial ,design ,methods

results and conclusions . 1b. Mentioned on page no
3, 6, 16 of artical

INTRODUCTION BACKGROUND AND OBJECTIVES

2a.Rationale is mentioned
2a. Scientific background and explanation of rationale on page no. 2 of journal
after introduction.
2b. Specific objectives or hypothesis 2b. Not Mentioned

METHOD TRAIL DESIGN

3a. Description of trial design( such as parallel, 3a. Mentioned on page

factorial) including allocation ratio no. 3 in methods

3b. Important changes to methods after trial 3b. Mentioned on page

commencement such as eligible criteria with reason no 4 of journal in
methodology
PARTICIPANTS
4a. Eligibility criteria for participants
4b. Settings and locations where the data were
collected
INTERVENTIONS
5. The interventions for each group with sufficient
details to allow replication, including how and when
they were actually administered
OUTCOMES
6a. Completely defined pre-specified primary and
secondary outcome measures, including how and
when they were assessed.
6b Any changes to trial outcomes after the trial
commenced, with reason.
4a. Mentioned on page no 3 in
study design
4b. Mentioned on page no 3, 4 in
methodology
5. details of control group is
mentioned on page 4 details of
study group is given in method on
page no 4 of journal.
6a. Mentioned (primary outcome
pg no. 5 secondary outcome on
page no 3 of journal
6b. Not Mentioned
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 SAMPLE SIZE

7a. How sample size was determined. 7a. Not mentioned

7b. When applicable, explanation of any 7b. Not mentioned

interim analyses and stopping guidelines.

RANDOMISATION SEQUENCE

8a. Method used to generate the random 8a.Not mentioned

allocation sequence .

GENERATION
8b. Type of randomisation; details of any 8b. Not mentioned
restriction (such as blocking and block size).
ALLOCATION
CONCEALMENT MECHANISM

9.Mechanism used to implement the random 9.Not mentioned

allocation sequence (such as sequentially numbered
containers), describing any steps taken to conceal
the sequence until interventions were assigned

IMPLEMENTATION

10. Who generated the random allocation sequence, who 10. Mentioned on page no. 4
enrolled participants, and who assigned participants to
interventions
BLINDING
11a. If done, who was blinded after assignment to 11a. Mentioned in method (The
interventions (for example, participants, care providers, person who analyzed the IWD study
those assessing outcomes) and how. was blinded to the group, but not
particapants.)
11b. If relevant, description of the similarity of 11b. Not mentioned
intervention.

STATISTICAL METHODS
12a. Statistical methods used to compare groups for primary 12a. Mentioned on page no 5 of
and secondary outcomes. journal in statistical anaysis

12b. Methods for additional analyses, such as subgroup 12b.

analyses and adjusted analyse.
RESULTS PARTICIPANTS FLOW
13a. For each group, the numbers of participants 13a. Mentioned in study group on
who were randomly assigned, received intended page 4
treatment, and were analysed for the primary
outcome.

13b. For each group, losses and exclusions after 13b. Mentioned 86 patients were
randomisation, together with reason excluded due to low adherence as
defined in the METHODS section)
RECRUITMENT

14a. Dates defining the periods of recruitment and 14a. Mentioned on page no. 6 in
follow-up results

14b. Why the trial ended or was stopped 14b. Not mentioned
BASELINE DATA
15. A table showing baseline demographic and 15. Mentioned on page no 8 of
clinical characteristics for each group journal

NUMBERS ANALYSED
16. For each group, number of participants 16. Mentioned in table on page
(denominator) included in each analysis and whether on page no 5
the analysis was by original assigned group

OUTCOMES AND ESTIMATION

17a. For each primary and secondary outcome, 17a. Mentioned in result on page
results for each group, and the estimated effect size on 4,5 and 6
and its precision (such as 95% confidence interval)

17b. For binary outcomes, presentation of both 17b. Not mentioned

absolute and relative effect sizes is recommended
SECTION ITEM CHECKLIST

ANCILLARY ANALYSIS
18. Results of any other analyses performed,18. Mentioned
including subgroup analyses and adjusted in discussion on page 15
analyses, distinguishing pre-specified from
exploratory

HARMS
19. All important harms or unintended effects in19.Not Mentioned
each group

DISCUSSIONS LIMITATIONS
20. Trial limitations, addressing sources of 20. Mentioned (limitations)
potential bias, imprecision, and, if relevant,
multiplicity of analyses
 GENERALISABILITY
21. Generalisability (external validity, 21. Not Mentioned
applicability) of the trial finding

INTERPRETATION
22. Interpretation consistent with results, 22. Other relevant evidences not
balancing benefits and harms, and Mentioned
considering other relevant evidence

OTHER INFORMATION REGISTRATION

23. Registration number and name of 23. Mentioned on page no 2
trial registry below the conclusion
PROTOCOL
24. Where the full trial protocol can be 24. Mentioned on page no 6
accessed, if available
FUNDING
25. Sources of funding and other 25. self funded
support (such as supply of drugs), role
of funders
PEDro SCALE
(Physiotherapy Evidence Database Scale)

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1) Eligibility criteria were specified YES

2) Subjects were randomly allocated to YES

groups

3) Allocation was concealed NO

4) The groups were similar at baseline NO

regarding the most important prognostic
indicators

5) There was blinding of all subjects NO

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6) There was blinding of all therapists who YES
administered the therapy

7) There was blinding of all assessors who NO

measured at least one key outcome

8) Measures of at least one key outcome were YES

obtained from more than 85% of the subjects
initially allocated to groups

9) All subjects for whom outcome measures were YES

available received the treatment or control
condition as allocated or where this was the
case, data for at least one key outcome was
analysed by “intention to treat”

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10) The results of between group statistical YES
comparisons are reported for at least one
key outcome

11) The study provides both point measures NO

of variability for at least one key outcome

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 Strength Weakness

1) Not mentioned the proper exercise program as they have

1)Actual number of participants are not clearly given in tittle
reflected
2) Allocation ratio is mentioned i.e..2:1

3)patient division is mentioned

4)Inclusion and exclusion criteria is specified
4)Statistical analysis method is mentioned
5) Statistical method is mentioned
2) How sample size was determined is not mentioned
3) Method used to generate the random allocation sequence
is not mentioned

6) Assessment follow up is mentioned

7)Blinding is not mentioned
8)Registration number and name of trial registry is
mentioned

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 SUGGESTIONS
• Type of study not mentioned in abstract
• Age group is not mentioned in title
• Control group is not fully controlled
• Allocation concealment is not given
• Allocation sequence is not given and method also is not explained
• Harms are not mentioned
• Reliability and validity of outcome is not given
• Relevant evidences not mentioned.

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THANK YOU