Randomised control trial
Claire Toulotte, Claudine Fabre, Benedicte Dangremont, Ghislaine Lensel, Andre ThevenonEffects of physical training on the physical capacity of frail, demented patients with a history of falling: a randomised controlled trial
Age and Ageing
2003; 32: 67-73
- Submitted by:Stefan Tino Kulnik - Physiotherapist
- Institution:Imperial College Healthcare NHS Trust
- Date submitted:17th November 2009
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes.
To examine the effects of a general physical training programme on mobility, balance, walking speed, flexibility, and number of falls in frail elderly people with dementia and a history of falls. The authors' hypothesis is that physical training to stimulate balance and muscle functions in these subjects would reduce the number of falls, improve walking speed, and increase autonomy.
To examine the effects of a general physical training programme on mobility, balance, walking speed, flexibility, and number of falls in frail elderly people with dementia and a history of falls. The authors' hypothesis is that physical training to stimulate balance and muscle functions in these subjects would reduce the number of falls, improve walking speed, and increase autonomy.
2
Design
2.1
Is the study design suitable for the objectives
Yes. Randomised controlled trial, planned as cross-over design. However, the data presented is only from the first period (before the cross-over). The intervention was offered to the control group at the end of the study but this was outside the investigation.
2.2
Who / what was studied?
Who was studied: 20 elderly patients with cognitive impairment (two subjects with diagnosis of Alzheimer's disease; other subjects did not have a diagnosis of dementia, but had 'mental impairment'); authors write that subjects had mini-mental state examination scores below 21, Table 1 however describes the subjects' characteristics as 'Mini mental state 14.7±7.6' (mean±SD) for the intervention group and 'Mini mental state 18.0±5.4' for the control group (?); all subjects had a history of falls (at least 2 or more falls, and fallen during 3 months prior the start of the study); two subjects had a history of stroke, one subject had Parkinson's disease, ten subjects had had fractures following falls; all subjects were able to walk at least 10 meters with or without assistance of a cane, frame or another person; the authors do not state clearly whether the subjects were residents in institutionalised care, however this seems to be the case as it is implied several times in the paper.
Who was excluded: subjects with unstable medical condition.
What was studied: the intervention studied was physical training in a group setting; two weekly session lasting one hour each over the course of 16 weeks; five subjects and two trainers per group; exercises aimed at increasing muscle strength, proprioception, static and dynamic balance and flexibility (examples for exercises are given in the paper, information about the complete contents of the classes is not provided);
Who was excluded: subjects with unstable medical condition.
What was studied: the intervention studied was physical training in a group setting; two weekly session lasting one hour each over the course of 16 weeks; five subjects and two trainers per group; exercises aimed at increasing muscle strength, proprioception, static and dynamic balance and flexibility (examples for exercises are given in the paper, information about the complete contents of the classes is not provided);
2.3
Was this the right sample to answer the objectives?
Unsure: see 2.2. of this appraisal with regards to conflicting information about subjects' mini-mental state examination scores; also, it would have been important to clearly state the setting, i.e. living in own home or in institutional care. NB: French study, UK distinction into residential care and nursing care may not apply; however it is stated that subjects were able to walk at least 10 meters with or without assistance.
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
Authors do not comment on sample size estimate, it appears that no power calculation or sample size estimate have been performed. The sample size of 10 in each group (training and control group) appears small for this study.
2.5
Were all subjects accounted for?
All subjects recruited appear to have completed the study, although this is not clearly stated by the authors. The authors do not describe the recruitment process.
2.6
Were all appropriate outcomes considered?
'Get up and go', timed 10 meter walk, and posturography are appropriate outcome measures for mobility and balance.
'Chair sit and reach' is used as an outcome measure for flexibility, testing how far the subject can reach towards the toes in a sitting position while one leg is straightened out, thereby testing flexibility of hamstrings and lumbar and thoracic spine. The authors provide a reference linking decreased flexibility to decreased stability and mobility in older people.
Number of falls is the appropriate outcome measure to evaluate falling; further aspects could have been added, such as severity of fall, or time to first fall after completion of the intervention.
Increased autonomy is listed as one of the aims of the investigated intervention, however the authors do not define their understanding of autonomy and do not comment on autonomy in their discussion. Probably an outcome measure on (in)dependence in general activities of daily living, such as the Barthel Index or similar, could have added to the perspective of subjects' autonomy.
'Chair sit and reach' is used as an outcome measure for flexibility, testing how far the subject can reach towards the toes in a sitting position while one leg is straightened out, thereby testing flexibility of hamstrings and lumbar and thoracic spine. The authors provide a reference linking decreased flexibility to decreased stability and mobility in older people.
Number of falls is the appropriate outcome measure to evaluate falling; further aspects could have been added, such as severity of fall, or time to first fall after completion of the intervention.
Increased autonomy is listed as one of the aims of the investigated intervention, however the authors do not define their understanding of autonomy and do not comment on autonomy in their discussion. Probably an outcome measure on (in)dependence in general activities of daily living, such as the Barthel Index or similar, could have added to the perspective of subjects' autonomy.
2.7
Has ethical approval been obtained if appropriate?
Authors do not comment on ethical approval. Verbal consent was gained from each subject.
2.8
Were the patients randomised between treatments?
Yes.
2.9
How was randomisation carried out?
Not commented on.
2.10
Are the outcomes clinically relevant?
Yes for: 'Get up and go', timed 10 meter walk, posturography, number of falls
Unsure for: 'Chair sit and reach'
Unsure for: 'Chair sit and reach'
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes.
Mini-mental state examination, referenced.
'Get up and go', 'Chair sit and reach', timed 10 meter walk, and posturography are well described be the authors and references provided.
Number of falls was recorded during the course of the 16 week period ('in the institution' - presumably subjects were residents in a care home).
Mini-mental state examination, referenced.
'Get up and go', 'Chair sit and reach', timed 10 meter walk, and posturography are well described be the authors and references provided.
Number of falls was recorded during the course of the 16 week period ('in the institution' - presumably subjects were residents in a care home).
3.2
Are the measurements valid?
Yes for: mini-mental state examination, number of falls, 'Get up and go', timed 10 meter walk, and posturography.
Unsure for: 'Chair sit and reach'
Unsure for: 'Chair sit and reach'
3.3
Are the measurements reliable?
As 3.2. of this appraisal.
3.4
Are the measurements reproducible?
Yes.
3.5
Were the patients and the investigators blinded?
No comment on whether subjects were blinded. No comment on whether physicians delivering the intervention were blinded.
Outcome measures were taken by an experienced physician blinded to whether subjects were in the intervention group or control group.
No comment on whether the person collecting falls data was blinded. No comment on whether the person administering the mini-mental state examination was blinded.
Outcome measures were taken by an experienced physician blinded to whether subjects were in the intervention group or control group.
No comment on whether the person collecting falls data was blinded. No comment on whether the person administering the mini-mental state examination was blinded.
4
Presentation of results
4.1
Are the basic data adequately described?
Unsure.
In the subjects' baseline characteristics (Table 1) the following information is not provided and would be useful: male-female ratio, number of diagnosed conditions, number of falls in the past year, identified risk factors for falls
In the subjects' baseline characteristics (Table 1) the following information is not provided and would be useful: male-female ratio, number of diagnosed conditions, number of falls in the past year, identified risk factors for falls
4.2
Were groups comparable at baseline?
From data given (Tables 1 and 2) unsure. Authors state that these data were not significantly different (p<0.05). Wide variation within SD, in particular 'Get up and go' (training group 67.6±38.9 seconds, control group 39.4±17.7 seconds, mean±SD), and mini-mental state examination score (training group 14.7±7.6, control group 18.0±5.4, mean±SD).
Further identification of risk factors for falls would have added to more comparable groups.
Further identification of risk factors for falls would have added to more comparable groups.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Results are not provided in table format with means and SDs. Results are described in % increase or reduction with p-values, and described in graphs in Figures 2-5. This makes own judgement by the reader more difficult.
Number of falls is reported for both groups during the 16 weeks intervention period, but only for the intervention group falls are reported for the six months following completion of the intervention.
Number of falls is reported for both groups during the 16 weeks intervention period, but only for the intervention group falls are reported for the six months following completion of the intervention.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
There appear to be conflicting p-values described in the text and in Figures 2-5.
4.5
Were side effects reported?
No comments on adverse effects in the intervention group.
5
Analysis
5.1
Are the data suitable for analysis?
Yes. However no comment on what degree of change in the balance and mobility related outcome measures is regarded as clinically significant.
5.2
Are the methods appropriate to the data?
Within my professional background as physiotherapist, I believe the statistical methods are appropriate (Student's unpaired t-test, ANOVA, Newman-Keuls method). Due to the lack of a power calculation and sample size estimate I would question the validity of the statistical conclusion.
5.3
Are any statistics correctly performed and interpreted?
As 5.3. of this appraisal.
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
The authors put their hypothesis and study in context with risk factors for falls in older people, deteriorating mobility and physical ability in old age, and lack of 'physical stimulation' and resulting detrimental effects in care institutions. They provide references to support their reasoning. They state that they are not aware of any previous study on the effect of physical training on the balance of frail older people with dementia and a history of falls. The results are discussed in relation to published work on physical training with cognitively normal older people (with and without a history of falls).
6.2
Is the discussion biased?
In the discussion, the authors describe the positive outcomes in their results and link them with related references. The authors do not discuss any limitations or any criticism to their study. In view of the lack of a power calculation and sample size estimate, incomplete presentation of results data, and sketchy baseline assessment of subjects with wide variations within the groups, I consider the discussion biased.
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
See 6.2. of this appraisal.
7.2
What level of evidence has this paper presented? (using CEBM levels)
CEBM level of evidence: 2b (low quality randomised controlled trial)
7.3
Does this paper help me answer my problem?
No.
8
Implementation
8.1
Can any necessary change be implemented in practice?
I would rate this study as a low quality randomised controlled trial, and therefore changes in practice based on this study would not be warranted. However, the hypothesis and treatment approach described in this study are highly interesting and relevant within the field of elderly medicine and dementia and certainly warrant further exploration.
8.2
What aids to implementation exist?
See 8.1. of this appraisal.
8.3
What barriers to implementation exist?
See 8.1. of this appraisal.