BMJ 2002;325:128-131 ( 20 July )

Papers

Randomised factorial trial of falls prevention among older people living in their own homes

Lesley Day, senior research fellow a, Brian Fildes, professor a, Ian Gordon, associate professor b, Michael Fitzharris, research fellow a, Harold Flamer, consultant geriatrician c, Stephen Lord, National Health and Medical Research Council research fellow d. 

a Accident Research Centre, PO Box 70A, Monash University, Clayton, Victoria 3800, Australia, b Statistical Consulting Centre, University of Melbourne, Melbourne, Victoria 3010, Australia, c Division of Geriatric Medicine, Maimonides Medical Center, Brooklyn, New York, NY 11219, USA, d Prince of Wales Medical Research Institute, Sydney, NSW 3021, Australia

Correspondence and reprint requests to: L Day Lesley.Day{at}general.monash.edu.au


    Abstract
Top
Abstract
Introduction
Methods
Results
Discussion
References

Objective: To test the effectiveness of, and explore interactions between, three interventions to prevent falls among older people.
Design: A randomised controlled trial with a full factorial design.
Setting: Urban community in Melbourne, Australia.
Participants: 1090 aged 70 years and over and living at home. Most were Australian born and rated their health as good to excellent; just over half lived alone.
Interventions: Three interventions (group based exercise, home hazard management, and vision improvement) delivered to eight groups defined by the presence or absence of each intervention.
Main outcome measure: Time to first fall ascertained by an 18 month falls calendar and analysed with survival analysis techniques. Changes to targeted risk factors were assessed by using measures of quadriceps strength, balance, vision, and number of hazards in the home.
Results: The rate ratio for exercise was 0.82 (95% confidence interval 0.70 to 0.97, P=0.02), and a significant effect (P<0.05) was observed for the combinations of interventions that involved exercise. Balance measures improved significantly among the exercise group. Neither home hazard management nor treatment of poor vision showed a significant effect. The strongest effect was observed for all three interventions combined (rate ratio 0.67 (0.51 to 0.88, P=0.004)), producing an estimated 14.0% reduction in the annual fall rate. The number of people needed to be treated to prevent one fall a year ranged from 32 for home hazard management to 7 for all three interventions combined.
Conclusions: Group based exercise was the most potent single intervention tested, and the reduction in falls among this group seems to have been associated with improved balance. Falls were further reduced by the addition of home hazard management or reduced vision management, or both of these. Cost effectiveness is yet to be examined. These findings are most applicable to Australian born adults aged 70-84 years living at home who rate their health as good.

What is already known on this topic
Multiple interventions are known to prevent falls among older people, but the relative importance of the different strategies is unknown

What this study adds
A weekly exercise programme focusing on balance, plus exercises at home, can help to prevent falls among Australians aged 70 years and over living at home and in good health

Home hazard management and vision screening and referral are not markedly effective in reducing falls when used alone but add value when combined with the exercise programme




    Introduction
Top
Abstract
Introduction
Methods
Results
Discussion
References

The prevention of falls among older people living in their own homes is an established priority in many countries. Randomised trials of single interventions among older people living at home have shown that exercise,1 medication reduction,2 support services arranged by trained volunteers,1 and home modifications arranged by occupational therapists3 are all effective interventions. Trials of multiple interventions among older people living at home have also shown reductions in the risk of falling.1

None of the designs of these trials, except one,2 permitted examination of the effects of each component separately or of any interactive effect between components. The main aim of this randomised controlled trial was to test the effectiveness of, and to explore any interactions between, three interventions to reduce falls among older people.


    Methods
Top
Abstract
Introduction
Methods
Results
Discussion
References

Setting and subjects
The study was conducted in the City of Whitehorse, a mainly middle class area of Melbourne, Australia. Potential participants were people aged 70 years and over living in their own home.

Design
The targeted risk factors were strength, balance, poor vision, and presence of home hazards. A full factorial design was used, with eight distinct groups (including a control) defined according to the presence or absence of each of the three interventions (fig 1). The control group received no intervention until after the study had ended.

Inclusion and exclusion criteria
Participants had to be living in their own home or apartment or leasing similar accommodation and allowed to make modifications. Potential participants were excluded if they did not expect to remain in the area for two years (except for short absences); had participated in regular to moderate physical activity with a balance improvement component in the previous two months; could not walk 10-20 metres without rest, help, or having angina; had severe respiratory or cardiac disease; had a psychiatric illness prohibiting participation; had dysphasia; had had recent major home modifications; had an education and language adjusted score >4 on the short portable mental status questionnaire4; or did not have the approval of their general practitioner.



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  		Fig 1.    Flow chart showing stages in study protocol and numbers of participants

Recruitment
We sent invitation letters and made follow up telephone calls to 11 120 people aged 70 years and over and registered on the Australian electoral roll for the area. The electoral roll includes almost all older people.

Assessment
Participants received a home visit by a trained assessor, who was initially blinded to group assignment. After informed consent was obtained, a baseline questionnaire was completed covering demographic characteristics; ability to perform basic activities and instrumental (more complex) activities of daily living5; use of support services; social outings and interests; the modified falls efficacy scale6; self rated health; and falls and medical history. Current prescription and over the counter drugs were recorded from containers at the participants' homes. Finally, the targeted risk factors (strength, balance, vision, and home hazards) were assessed (see table 1 in the full version of this article on bmj.com). Participants were then assigned (by computer generated randomisation) to an intervention group by an independent third party via telephone.

After 18 months, the risk factor assessments were repeated in a proportion of participants (n=442) randomly selected by an assessor blinded to the intervention group (we used only a proportion of the participants because resources to reassess the whole study group were not available and this assessment was of secondary importance to the study's main goal). Strength and balance were also measured at the final exercise class of the first 177 participants to complete the 15 week programme, 79 of whom were among the 442 subsequently selected for final reassessment.

Interventions
We sent all participants a letter outlining their assigned interventions, advising of necessary actions.

Strength and balance--- Participants attended a weekly exercise class of one hour for 15 weeks, supplemented by daily home exercises. The exercises were designed by a physiotherapist to improve flexibility, leg strength, and balance, and 30-35% of the total content was devoted to balance improvement. Exercises could be replaced by a less demanding routine, depending on the participant's capability. Transport was provided where necessary.

Home hazards--- Home hazards were removed or modified either by the participants themselves or via the City of Whitehorse's home maintenance programme. Home maintenance staff visited the home, providing a quotation for the work, including free labour and materials up to the value of $A100 (£37; $54; 60).

Vision--- If a participant's vision tested below predetermined criteria and if he or she was not already receiving treatment for the problem identified, the participant was referred to his or her usual eye care provider, general practitioner, or local optometrist, to whom the vision assessment results were given. Participants not receiving the vision intervention were provided with the Australian Optometrist Association's brochure on eye care for those aged over 40.

Outcome measures
Participants reported falls using a monthly postcard calendar system to record daily falls outcome. Participants not returning their calendar within five working days of the end of each month, and those recording a fall, were followed up by telephone by a research assistant blinded to group assignment.

Analyses
We calculated changes in levels of risk factor by comparing measures at baseline with those at the end of the study for the 442 randomly selected participants. We calculated mean scores for each of the measures. Analysis followed the main effects model such that those who were assigned a particular intervention were compared with those who were not---for example, exercise versus no exercise.

We analysed the time from randomisation to a participant's first fall using Cox's proportional hazards model. Effects on the annual fall rate were estimated within the Cox model, confidence intervals being determined using the bootstrap method.

All analyses were performed on an intention to treat basis.




    Results
Top
Abstract
Introduction
Methods
Results
Discussion
References

A total of 1107 participants received a baseline assessment and group assignment (fig 1). Demographic characteristics and baseline risk factor measures in the eight study groups were similar. The distribution of group assignment among the 442 participants who were randomly selected for reassessment was representative of the combined study group, and demographic characteristics and baseline risk factor measures were similar to those of the combined study group.

Falls outcome
The three main interventions did not interact so only results based on a main effects model are reported. Figure 2 shows the Kaplan-Meier curves for the intervention and non-intervention groups for the three main effects separately. There was a significant benefit for exercise alone, and a significant effect (P<0.05) for all interventions in which exercise was combined with other interventions (table). The strongest effect was observed for all three interventions together.



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  		Fig 2.    Kaplan-Meier plots showing the probability of remaining fall-free, for each of the three interventions separately. All participants are represented in each of the three graphs


                              
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Effect on falls outcome, single and combined interventions

Risk factors for falls
The measures of strength and balance undertaken at the final exercise class of the first 177 participants showed significant improvements in mean number of errors made during coordinated stability testing (12.2 v 9.7, P<0.001) and in maximal balance range (13.3 cm v 15.1 cm, P<0.001). Quadriceps strength improved in weaker legs (18.7 kg v 23.6 kg, P<0.001) and stronger legs (21.9 kg v 24.6 kg, P<0.001).

After 18 months, maximal balance range showed little change in the participants receiving the exercise intervention (decrease of 0.64 cm from mean of 13.7 cm) but decreased over time among the control group (decrease of 1.8 cm from mean of 13.6 cm) (P=0.01). This suggests that the exercise intervention slowed the rate of age related deterioration. There were no other significant improvements in the strength and balance measures.

The mean average number of hazards in the participants receiving home hazards intervention decreased from 10.2 to 7.4, compared with a decrease from 9.1 to 7.9 in the control group (P<0.001). Visual acuity (high contrast) improved marginally among the non-intervention group (difference in mean value of 0.046) but remained largely unchanged in the intervention group (P=0.03). No other differences were seen in the vision measures.




    Discussion
Top
Abstract
Introduction
Methods
Results
Discussion
References

We did not find an interactive effect of the interventions on falls outcome; rather, the interventions were additive. A study of withdrawal from psychotropic drug treatment combined with exercise also found no interactive effect.2

Unlike most previous studies of exercise among unselected older people living in their own homes,1 these results show that a supervised exercise programme for this group for one hour a week for 15 weeks, supplemented with home exercise for up to 12 months, can reduce falls. The reduction occurred despite relatively poor compliance with the home exercise sessions (see bmj.com), which were intended to be daily, but in fact were performed twice weekly on average. This is the shortest programme of the lowest intensity shown to reduce falls. A greater reduction in falls has been shown in other programmes with more intense exercise regimes. 2 7 8

The limited effect of the other two interventions on falls outcome may be partly related to insufficient intensity of the interventions.

As the participants differed somewhat from the general older population living at home (see bmj.com), the findings are most applicable to older adults living at home with similar characteristics---namely, Australian born, aged 70-84, and rating their health as good to excellent. Other complementary trials may be needed to examine the effectiveness of falls interventions among people living at home who are aged over 85, in poorer health, or from non-English speaking backgrounds.

The combined effect of all three interventions produced the largest falls reduction, with the exercise intervention making the greatest contribution. The falls reducing effect of this intervention was associated with improved balance. Exercise programmes that promote balance should be considered for wider implementation among older people living at home.

Cost effectiveness studies of exercise and other successful interventions would provide important information on which to base resource allocation for the prevention of falls among older people living at home.

    Acknowledgments

The authors are indebted to Sandra Hills, Fiona McRae, and Elizabeth Fowler, City of Whitehorse, for project coordination; Barbara Fox, Kate Edwards-Coghill, Maria McKinnon, Renee Bush, Dianne Clay, and Sue Morton for home visits and assessments; Sue Vincent for developing and supervising the exercise programme and the leaders of the exercise class for implementing it; Margaret Stevens and Nicole Bennet of the Injury Control Council of Western Australia for providing the Falls Project Home Hazard Assessment protocols; City of Whitehorse home maintenance staff for help with home modifications; Jane Matthews of the Statistical Centre and Peter MacCallum of the Cancer Institute, Melbourne, for use of the RANDOM software; and study participants for their contribution.

Contributors: See bmj.com

    Footnotes

Funding: This work was funded by the National Health and Medical Research Council (Commonwealth Department of Health and Aged Care), Victorian Department of Human Services (Aged Care), City of Whitehorse, Victorian Health Promotion Foundation, Rotary, and the National Safety Council.

Competing interests: None declared.

The full version of this article appears on bmj.com


    References
Top
Abstract
Introduction
Methods
Results
Discussion
References

1. Feder G, Cryer C, Donovan S, Carter Y, on behalf of the guidelines' development group. Guidelines for the prevention of falls in people over 65. BMJ 2000; 321: 1007-1011[Free Full Text].
2. Campbell AJ, Robertson CM, Gardner MM, Norton RN, Buchner DM. Psychotropic medication withdrawal and a home based exercise programme to prevent falls: a randomised controlled trial. J Am Geriatr Soc 1999; 47: 850-853[Web of Science][Medline].
3. Cummings RG, Thomas M, Szonyi G, Salkeld G, O'Neill E, Westbury C, et al. Home visits by an occupational therapist for assessment and modification of environmental hazards: a randomised trial of falls prevention. J Am Geriatr Soc 1999; 47: 1397-1402[Web of Science][Medline].
4. Pfieffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc 1975; 23: 433-441[Web of Science][Medline].
5. Lawton MP, Moss M, Fulcomer M, Kleban MH. A research and service oriented multilevel assessment instrument. J Gerontol 1982; 37: 91-99[Abstract/Free Full Text].
6. Hill KD, Schwarz JA, Kalogeropoulos AJ, Gibson SJ. Fear of falling revisited. Arch Phys Med Rehabil 1996; 77: 1025-1029[CrossRef][Web of Science][Medline].
7. Buchner DM, Cress ME, de Lateur BJ, Esselman PC, Margherita AJ, Price R, et al. The effect of strength and endurance training on gait, balance, fall risk, and health services use in community-living older adults. J Gerontol A Biol Sci Med Sci 1997; 52: M218-M225[Abstract].
8. Campbell AJ, Robertson CM, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ 1997; 315: 1065-1069[Abstract/Free Full Text].

(Accepted 2 January 2002)

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Old people and physical exercises.
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