Effect of a multifactorial interdisciplinary intervention on mobility-related disability in frail older people: randomised controlled trial

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Abstract

Background

Interventions that enhance mobility in frail older people are needed to maintain health and independence, yet definitive evidence of effective interventions is lacking. Our objective was to assess the impact of a multifactorial intervention on mobility-related disability in frail older people.

Methods

We conducted a randomised, controlled trial with 241 frail community-dwelling older people in Sydney, Australia. Participants were classified as frail using the Cardiovascular Health Study definition, did not have severe cognitive impairment and were recently discharged from an aged care and rehabilitation service. The experimental group received a 12 month multifactorial, interdisciplinary intervention targeting identified frailty components. Two physiotherapists delivered a home exercise program targeting mobility, and coordinated management of psychological and medical conditions with other health professionals. The control group received usual care. Disability in the mobility domain was measured at baseline and at 3 and 12 months using the International Classification of Functioning, Disability and Health framework. Participation (involvement in life situations) was assessed using the Life Space Assessment and the Goal Attainment Scale. Activity (execution of mobility tasks) was measured using the 4-metre walk and self-report measures.

Results

The mean age of participants was 83.3 years (SD: 5.9 years). Of the participants recruited, 216 (90%) were followed-up at 12 months. At this time point, the intervention group had significantly better scores than the control group on the Goal Attainment Scale (odds ratio 2.1; 95% confidence interval (CI) 1.3 to 3.3, P = 0.004) and Life Space Assessment (4.68 points, 95% CI 1.4 to 9.9, P = 0.005). There was no difference between groups on the global measure of participation or satisfaction with ability to get out of the house. At the activity level, the intervention group walked 0.05 m/s faster over 4 m (95% CI 0.0004 to 0.1, P = 0.048) than the control group, and scored higher on the Activity Measure for Post Acute Care ( P < 0.001).

Conclusions

The intervention reduced mobility-related disability in frail older people. The benefit was evident at both the participation and activity levels of mobility-related disability.

Trial registration

Australia and New Zealand Clinical Trials Register (ANZCTR): ANZCTRN12608000507381.

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Most cited references 28

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Comfortable and maximum walking speed of adults aged 20-79 years: reference values and determinants.

Richard Bohannon (1996)

to establish reference values for both comfortable and maximum gait speed and to describe the reliability of the gait speed measures and the correlation of selected variables with them. descriptive and cross-sectional. subjects were 230 healthy volunteers. Gait was timed over a 7.62 m expanse of floor. Actual and height normalized speed were determined. Lower extremity muscle strength was measured with a hand-held dynamometer. mean comfortable gait speed ranged from 127.2 cm/s for women in their seventies to 146.2 cm/s for men in their forties. Mean maximum gait speed ranged from 174.9 cm/s for women in their seventies to 253.3 cm/s for men in their twenties. Both gait speed measures were reliable (coefficients > or = 0.903) and correlated significantly with age (r > or = -0.210), height (r > or = 0.220) and the strengths of four measured lower extremity muscle actions (r = 0.190-0.500). The muscle action strengths most strongly correlated with gait speed were nondominant hip abduction (comfortable speed) and knee extension (maximum speed). these normative values should give clinicians a reference against which patient performance can be compared in a variety of settings. Gait speed can be expected to be reduced in individuals of greater age and of lesser height and lower extremity muscle strength.

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Statistical considerations in the intent-to-treat principle.

John M. Lachin (2000)

This paper describes some of the statistical considerations in the intent-to-treat design and analysis of clinical trials. The pivotal property of a clinical trial is the assignment of treatments to patients at random. Randomization alone, however, is not sufficient to provide an unbiased comparison of therapies. An additional requirement is that the set of patients contributing to an analysis provides an unbiased assessment of treatment effects, or that any missing data are ignorable. A sufficient condition to provide an unbiased comparison is to obtain complete data on all randomized subjects. This can be achieved by an intent-to-treat design wherein all patients are followed until death or the end of the trial, or until the outcome event is reached in a time-to-event trial, irrespective of whether the patient is still receiving or complying with the assigned treatment. The properties of this strategy are contrasted with those of an efficacy subset analysis in which patients and observable patient data are excluded from the analysis on the basis of information obtained postrandomization. I describe the potential bias that can be introduced by such postrandomization exclusions and the pursuant effects on type I error probabilities. Especially in a large study, the inflation in type I error probability can be severe, 0.50 or higher, even when the null hypothesis is true. Standard statistical methods for the analysis of censored or incomplete observations all require the assumption of missing at random to some degree, and none of these methods adjust for the potential bias introduced by post hoc subset selection. Nor is such adjustment possible unless one posits a model that relates the missing observations to other observed information for each subject-models that are inherently untestable. Further, the subset selection bias is confounded with the subset-specific treatment effect, and the two components are not identifiable without additional untestable assumptions. Methods for sensitivity analysis to assess the impact of bias in the efficacy subset analysis are described. It is generally believed that the efficacy subset analysis has greater power than the intent-to-treat analysis. However, even when the efficacy subset analysis is assumed to be unbiased, or have a true type I error probability equal to the desired level alpha, situations are described where the intent-to-treat analysis in fact has greater power than the efficacy subset analysis. The intent-to-treat design, wherein all possible patients continue to be followed, is especially powerful when an effective treatment arrests progression of disease during its administration. Thus, a patient benefits long after the patient becomes noncompliant or the treatment is terminated. In such cases, a landmark analysis using the observations from the last patient evaluation is likely to prove more powerful than life-table or longitudinal analyses. Examples are described.

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A randomized, controlled trial of quadriceps resistance exercise and vitamin D in frail older people: the Frailty Interventions Trial in Elderly Subjects (FITNESS).

Nancy Latham, Craig Anderson, Arier C Lee … (2003)

To determine the effectiveness of vitamin D and home-based quadriceps resistance exercise on reducing falls and improving the physical health of frail older people after hospital discharge. Multicenter, randomized, controlled trial with a factorial design. Five hospitals in Auckland, New Zealand, and Sydney, Australia. Two hundred forty-three frail older people. Patients were randomized to receive a single dose of vitamin D (calciferol, 300,000 IU) or placebo tablets and 10 weeks of high-intensity home-based quadriceps resistance exercise or frequency-matched visits. The primary endpoints were physical health according to the short-form health survey at 3 months and falls over 6 months. Physical performance and self-rated function were secondary endpoints. Assessments took place in the participants' homes at 3 and 6 months after randomization and were performed by blinded assessors. There was no effect of either intervention on physical health or falls, but patients in the exercise group were at increased risk of musculoskeletal injury (risk ratio = 3.6, 95% confidence interval = 1.5-8.0). Vitamin D supplementation did not improve physical performance, even in those who were vitamin D deficient (<12 ng/mL) at baseline. Neither vitamin D supplementation nor a home-based program of high-intensity quadriceps resistance exercise improved rehabilitation outcomes in frail older people after hospitalization. There was no effect of vitamin D on physical performance, and the exercises increased the risk of musculoskeletal injury. These findings do not support the routine use of these interventions at these dosages in the rehabilitation of frail older people.

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Author and article information

Journal

Journal ID (nlm-ta): BMC Med

Journal ID (iso-abbrev): BMC Med

Title: BMC Medicine

Publisher: BioMed Central

ISSN (Electronic): 1741-7015

Publication date Collection: 2012

Publication date (Electronic): 15 October 2012

Volume: 10

Page: 120

Affiliations

[1 ]Rehabilitation Studies Unit, Sydney Medical School, The University of Sydney, Ryde, 2112, Australia

[2 ]The George Institute for Global Health, The University of Sydney, Sydney, 2000, Australia

[3 ]Curran Ageing Research Unit, Division of Rehabilitation and Aged Care, Hornsby Ku-ring-gai Health Service, Hornsby, NSW, Australia

[4 ]Falls and Balance Research Group, Neuroscience Research Australia, University of New South Wales, Sydney, 2031, Australia

Article

Publisher ID: 1741-7015-10-120

DOI: 10.1186/1741-7015-10-120

PMC ID: 3517433

PubMed ID: 23067364

SO-VID: 5ea5281a-0298-4685-b14d-a8eb1c5311ed

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date received : 17 February 2012

Date accepted : 15 October 2012

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Effect of a multifactorial interdisciplinary intervention on mobility-related disability in frail older people: randomised controlled trial

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Most cited references 28

Comfortable and maximum walking speed of adults aged 20-79 years: reference values and determinants.

Statistical considerations in the intent-to-treat principle.

A randomized, controlled trial of quadriceps resistance exercise and vitamin D in frail older people: the Frailty Interventions Trial in Elderly Subjects (FITNESS).

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Cited by 49