MOBILITY DIFFICULTIES ARE common among older

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1 118 ORIGINAL ARTICLE Construct and Predictive Validity of a Self-Reported Measure of Preclinical Mobility Minna Mänty, MSc, Ari Heinonen, PhD, Raija Leinonen, PhD, Timo Törmäkangas, MSc, Ritva Sakari-Rantala, MSc, Mirja Hirvensalo, PhD, Mikaela B. von Bonsdorff, MSc, Taina Rantanen, PhD ABSTRACT. Mänty M, Heinonen A, Leinonen R, Törmäkangas T, Sakari-Rantala R, Hirvensalo M, von Bonsdorff MB, Rantanen T. Construct and predictive validity of a self-reported measure of preclinical mobility limitation. Arch Phys Med Rehabil 7;88: Objectives: To validate self-reported preclinical mobility limitation concept and self-report assessment method against muscle power and walking speed, and to study the predictive validity of preclinical mobility limitation with respect to future risk of manifest mobility limitation. Design: Observational prospective cohort study and crosssectional analysis. Setting: Research laboratory and community. Participants: A total of 632 community-living (age range, 75 81y) women and men took part in the baseline assessments and 32 persons in the semi-annual interviews on mobility limitation over 2 years. Interventions: Not applicable. Main Outcome Measures: Walking speed, muscle power, and self-reported preclinical and manifest mobility limitation. Preclinical mobility limitation was defined as self-reported tiredness or modification of task performance without task difficulty. At baseline, 4 subgroups were created according to self-reported preclinical mobility limitation in any of 3 mobility tasks (walking 2km, walking.5km, climbing up stairs): no limitation, preclinical limitation, and minor and major manifest limitation. Results: At baseline, participants with preclinical mobility limitation showed intermediate levels of walking speed and muscle power, compared with those with no limitation or manifest mobility limitation. Participants reporting baseline preclinical mobility limitation had 3- to 6-fold higher age- and sex-adjusted risk of progressing to major manifest mobility limitation during the 2-year follow-up compared with participants with no limitation at baseline, whereas the risk among those with minor limitation at baseline was 14- to 18-fold higher compared with those with no limitation. Conclusions: The self-report assessment tool proved to be a valid measure to capture the early signs of disability and may See commentary p From the Finnish Centre for Interdisciplinary Gerontology (Mänty, Leinonen, Törmäkangas, von Bonsdorff, Rantanen), Department of Health Sciences (Heinonen, Sakari-Rantala), and Department of Sport Sciences (Hirvensalo), University of Jyväskylä, Jyväskylä, Finland. Supported by the Ministry of Health and Social Affairs, the City of Jyväskylä, Finnish Cultural Foundation and Juho Vainio Foundation. No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the author(s) or upon any organization with which the author(s) is/are associated. Reprint requests to Minna Mänty, MSc, The Finnish Center for Interdisciplinary Gerontology, University of Jyväskylä, PO Box 35 (Viveca), FIN-414 Jyväskylä, Finland, minna.manty@sport.jyu.fi /7/ $32./ doi:1.116/j.apmr serve as an inexpensive tool for identifying those nondisabled persons at high risk for future disability. Key Words: Aging; Disabled persons; Muscles; Rehabilitation; Walking. 7 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation MOBILITY DIFFICULTIES ARE common among older people, increasing the risk of further disability and development of dependency, and are an important public health concern. Difficulties in mobility are often the first noticeable signs of decline in functional ability. 1-3 In the perspective of primary prevention, it is important to identify people who are as yet nondisabled but are at high risk for future functional decline by characterizing an early functional state associated with increased risk for subsequent disability. 4 Earlier findings have shown that poor performance in objective measures of physical performance such as lower-extremity muscle strength and walking speed are highly predictive of subsequent disability 5-8 and dependency 1,9 among nondisabled older adults and thus may be considered as a criterion standard in terms of impairment level assessment relevant in the disablement process. In certain circumstances, however, we also need valid selfreport measures, because they do not require a specific place or equipment, and because they may be administered, for example, through phone interview or questionnaire. Most existing selfreport instruments primarily assess difficulty, inability, or degree of assistance required to perform specific tasks of mobility, household management or personal care. Thus, these measures may not be sensitive enough to recognize early steps in the course of disability. 1,11 In early stages of functional decline prior to the onset of task difficulty, older persons may be able to compensate for underlying disease by modifying their task performance and thereby maintain their function without the perception of difficulty. This stage of functional decline, that is, changes in method, frequency, or time used in task performance or increased tiredness, 15,16 has been proposed as preclinical disability. There is some evidence that persons with preclinical disability have an increased risk for disability. 12,14 The aim of this study was to validate the self-reported preclinical mobility limitation concept and assessment tool among Finnish older population by investigating (1) whether self-reported modification of task performance or increased tiredness without task difficulty, that is, preclinical mobility limitation, is associated with decrements in objective measures of muscle power and maximal walking speed and (2) whether preclinical mobility limitation is predictive of occurrence of major difficulties in performing the task, that is, manifest mobility limitation. METHODS Design This observational study is based on analyses of baseline data and 2-year follow-up on the development of mobility

2 PRECLINICAL MOBILITY LIMITATION, Mänty 119 limitation. In the cross-sectional analyses, the validation of preclinical mobility limitation assessment tool was done against the criterion standard, that is, muscle power and walking speed, using the baseline data of the 2-year randomized controlled trial Screening and Counseling for Physical Activity and Mobility in Older People (SCAMOB) 17 (ISRCTN ). The predictive validity of preclinical mobility limitation was studied as risk for developing future manifest mobility limitation in the SCAMOB control group, where the naturally occurring changes in function took place. Maximal walking speed and muscle power examinations and face-toface interview on mobility were performed at baseline. In addition, telephone interviews about mobility were carried out 3 times at 6-month intervals after the baseline and face-to-face interview again at 2-year follow-up point. Participants The original target population consisted of all 75- to 81-yearold registered residents of the City of Jyväskylä, Central Finland, living in the city center area in March 3 (N 131). Subjects selection procedure has been described in detail elsewhere. 17 To be eligible to this study, persons had to be able to walk 5m without assistance, have Mini-Mental State Examination (MMSE) 18 score greater than 21, have no medical contraindications for physical activity, and be only moderately physically active or sedentary. Persons with specific physical activities were excluded from the study. After screening we had 632 participants in the cross-sectional analysis and 314 participants in the SCAMOB control group for the follow-up of the naturally occurring changes in function. Participants without the outcome of major manifest limitation at the baseline were followed up for the development of mobility limitation in 2-km walk (n 266),.5-km walk (n 32), and climbing up stairs (n 295). The study was approved by the Ethics Committee of the Central Finland Health Care District. All participants gave their written informed consent before the study. Measurements Background characteristics. Information on self-reported physician-diagnosed chronic conditions lasting over 3 months and prescription medication was collected during the face-toface interviews at the participant s home. During the studycenter visit, the study nurse checked the responses concerning chronic diseases and prescription medications filled in by the interviewers at home interviews. Depression was measured with Center for Epidemiologic Studies Depression Scale (CES- D) 19 and cognitive impairment was assessed with the MMSE. 18 Maximal walking speed. We measured walking speed over 1m in the study-center corridor. Participants were allowed 2- to 3-m acceleration before the start line and they were encouraged to walk as fast as possible without risking their health. Timing was done using a stopwatch. Participants wore walking shoes or sneakers, and use of a walking aid was allowed if needed. Walking speed has previously been shown to be a reliable and valid measurement of functional performance among older people. 6 The test-retest coefficient of variation (CV) for maximal walking speed in our study center was 4.6%. Leg extensor muscle power. At baseline, we measured leg extensor muscle power of a single leg using Nottingham Leg Extensor Power Rig. 21,a During testing, the participant was seated with arms folded, 1 foot was placed on the pedal attached to a flywheel, and the other foot rested on the floor. After 2 to 3 practice trials, each participant was asked to push the pedal as hard and fast as possible. Five to 9 maximal efforts Fig 1. Subgroup division according to the level of mobility limitation and its association to the hypothesized development of mobility limitation. per leg, separated by 3-second rests, were conducted. 22,23 In this study, the best performance of dominant leg was used as the measure of maximal power. Muscle power measurement with the Nottingham power rig has been validated and found to be safe and acceptable among older people. 21 The test-retest CV in our study center was 8%. 22 Preclinical and manifest mobility limitation. The questions on mobility were formulated according to the hypothesis that the progression of major manifest mobility limitation develops through stages of preclinical mobility limitation and minor manifest mobility limitation (fig 1). Self-reported mobility was studied using a structured interview regarding walking 2.km, walking.5km, and climbing up 1 flight of stairs. The questions were formulated as follows: Do you have difficulty in... and 5 alternative response options were given: (1) able to manage without difficulty, (2) able to manage with some difficulty, (3) able to manage with great deal of difficulty, (4) able to manage only with help of another person, and (5) unable to manage even with help. To identify persons at an early stage of mobility limitation, that is, preclinical mobility limitation, additional questions were posed to participants who reported no task difficulty. The questions concerned the modification of task performance and the alternatives given were resting in the middle of the performance, using an aid, taking support from handrails, having reduced the frequency of performing the task, having slowed down performance of the task, experiencing tiredness when performing the task, or some other change in carrying out the task. Subgroup division. At baseline 4 subgroups for each mobility task were created according to self-reported mobility difficulties and task modification: (1) no limitation (no mobility difficulties and no modification), (2) preclinical limitation (no mobility difficulty and 1 modification), (3) minor manifest limitation (some difficulty), and (4) major manifest limitation (great deal of difficulty, need for help of another person or not able to manage even with help) (see fig 1). Reliability of mobility assessment. We assessed test-retest reliability for the mobility and preclinical limitation questions among a sample of 29 people of similar age by replicating the questions in an interval of 2 weeks. The agreement of selfreports between 2 different days for the question on the 2-km walk was 93%; for the.5-km walk, 97%; and for climbing up 1 flight of stairs, 1%. The task modification questions agreement ranged from 93% to 1% for the 2-km walk, from 97% to 1% for the.5-km walk, and from 72% to 1% for walking up 1 flight of stairs.

3 111 PRECLINICAL MOBILITY LIMITATION, Mänty Statistical Analysis Means and standard deviations (SDs) were used as descriptive statistics. Analyses of covariance were used to estimate the mean differences in muscle power and maximal walking speed between the groups based on hypothesized progression of mobility limitation. Age, sex, and number of long-term diseases and prescription medication were used as covariates. The relative differences between the study groups were determined using log transformation of the variables. When the 95% confidence intervals (CIs) did not include zero, the differences were regarded as statistically significant at equal to.5. These analyses were performed using Mplus software. b In the 2-year follow-up, we constructed a generalized estimating equations model 24 on the dichotomized (no major manifest limitation, major manifest limitation) mobility variables to test the significance of subgroup differences in the risk for major manifest limitation over time. Subjects who had major manifest limitation with mobility task at baseline were excluded from the analyses of the given task. The analyses were performed in SAS, c using the GENMOD procedure. To study factors that may underlie on the theoretic pathway to mobility limitation, 3 separate models were constructed for each mobility task using sex, age, presence of chronic diseases known to affect mobility (osteoarthritis, rheumatoid arthritis, diabetes, chronic obstructive pulmonary disease, ischemic heart disease, myocardial insufficiency, sciatica), depressive symptoms (CES-D score), weight, height, walking speed, and muscle power as covariates. For cases with missing values in a mobility task at some point of the 2-year follow-up, data were imputed with the multiple imputation procedure implemented in SAS by using information on the other mobility tasks and baseline information such as number of long-term diseases, and MMSE and CES-D scores. Sensitivity analyses performed suggested no significant differences in effects due to imputation. The number of missing observations at different measurement points ranged from 9 to 28. Subjects who died over the course of the study were censored at the date of their death and missing values were not imputed. During the 2-year follow-up, 8 participants died. RESULTS The mean age of our study population (N 632) was years and 75% were women. At the baseline all the participants (N 632) completed the face-to-face interview on mobility and 629 participants performed the maximal walking speed test and 614 participants the muscle power measurement. In our follow-up sample, attrition over 2 years was under 1%. A substantial number of the participants who reported no difficulty in the 2-km walk,.5-km walk, or climbing up stairs reported task modification or increased tiredness in performing the task. Depending on the task being assessed, altogether 31% to 55% of the participants were categorized into the preclinical mobility limitation subgroup. The distribution of participants according to our subgroup division is given in detail in table 1. Baseline characteristics according to self-reported mobility in the 2-km walk are shown in table 2. According to the number of long-term diseases and prescription medication, length of education, body mass index, depressive symptoms, muscle power, and walking speed, participants with preclinical mobility limitation were an intermediate group between the participants reporting no limitation and those reporting manifest limitation. Similar results were observed also when comparison was done based on the.5-km walk or stair climbing. Table 1: Frequency of Participants According to the Level of Mobility at Baseline for the 2-km Walk,.5-km Walk, and Climbing Up Stairs (N 632) Activity No No Difficulty Preclinical Minor Manifest Difficulty Major Manifest 2-km walk 167 (26) 257 (41) 118 (19) 9 (14).5-km walk 347 (55) 194 (31) 7 (11) 21 (3) Climb up stairs 132 (21) 346 (55) 111 (18) 43 (7) NOTE. Values are n (%). Validation Against Criterion Standard We validated the self-report assessment tool against objectively measured maximal walking speed and muscle power. Adjusted mean percentage differences between the subgroups in maximal walking speed and muscle power compared with preclinical limitation subgroup are given in figure 2. The participants with preclinical mobility limitation had intermediate levels of maximal walking speed and muscle power between participants with no limitation and those with manifest limitation. This result was consistent in all 3 mobility tasks, being most evident in the 2-km walk and climbing up 1 flight of stairs (see fig 2). The participants reporting no limitation had significantly (P.5) faster walking speed (11% %) and higher muscle power (14% 16%), compared with those with preclinical mobility limitation. In proportion, the participants reporting either minor or major manifest limitation had significantly (P.5) slower walking speed (1% 28%), and lower muscle power (13% 26%), compared with participants with preclinical limitation. Predictive Validity The prevalence of major manifest limitation in the 2-km walk,.5-km walk, and climbing up 1 flight of stairs during the 24-month follow-up are shown in figure 3. The risk for the development of major manifest mobility limitation was intermediate among participants with preclinical mobility limitation compared with those with no limitation or minor manifest limitation. Table 3 shows the risk ratios for the onset of task-specific major manifest limitation in each mobility task compared with the subjects with no limitation. In the first model, adjusted for sex and age, preclinical limitation in the 2-km walk and.5-km walk increased the risk for major manifest limitation almost 3- to 6-fold compared with participants with no limitation. The trend was similar also in climbing up stairs, only with nonsignificant risk ratio. Subjects with minor manifest limitation had 14- to 18-fold risk for major manifest limitation in each mobility task compared with those with no limitation. In the second and third model, we adjusted the risk ratios with potential confounders together with lowerextremity muscle power and maximal walking speed. These procedures attenuated the risk ratios in all of the 3 tasks (table 3). DISCUSSION Our results indicate that self-reported preclinical mobility limitation is a valid measure to identify persons at high risk for future manifest mobility limitation. In our cross-sectional part of the study, objective measures of maximal walking speed and muscle power were associated in a stepwise relationship with the 4 categories of mobility limitation, ranging from no limitation to preclinical limitation and further to minor and major

4 PRECLINICAL MOBILITY LIMITATION, Mänty 1111 Table 2: Baseline Characteristics (N 632) According to the Level of in Walking 2km No Difficulty Difficulty Characteristics No Preclinical Minor Manifest Major Manifest Age (y) No. of chronic diseases No. of prescription medications Education (y) Body mass index (kg/m 2 ) MMSE Muscle power (W/kg) Maximal walking speed (m/s) CES-D NOTE. Values are mean SD. *One-way analysis of variance. P* manifest limitation. Participants reporting preclinical mobility limitation had intermediate walking speed and muscle power between those with no limitation and those with minor or major manifest limitation. In addition, our observational follow-up study confirmed that the self-reported preclinical mobility limitation predicted development of major manifest limitation in the near future. Our findings are in accordance with the previous findings of Fried, 12,13 Wolinsky, 14 and Avlund 15,16,25 and colleagues providing criterion and predictive validity for the preclinical mobility limitation concept. In the earlier studies of self-reported preclinical mobility limitation, the target population has consisted of 7- to 8-year-old high-functioning American women 12,13 or late-middle-aged African Americans. 14 Our study population represented sedentary community-living older people. In addition, to our knowledge, muscle power or selfreported ability to walk 2km has not been used as outcome in the earlier studies of preclinical disability. In the work of Fried 12,13 and Wolinsky, 14 preclinical mobility limitation was assessed by self-reported changes in the method or decreased frequency of task performance without perceived task difficulty. This approach suggests that people are able to compensate for underlying disease by modifying their task performance. This is in line with the theory of selective optimization with compensation by Baltes and Baltes, 26 which has previously been mostly applied to studies on cognitive functioning. Baltes and Baltes 26 described 3 adaptational processes: selection denotes a restriction of involvement in activities in response to lost capacity, optimization refers to optimization processes like pacing activities to enable one to continue performing activities, and compensation involves efforts to meet goals by new means (eg, modifying behaviors, using assistive devices). In the recent years, this theory has been applied to physical functioning, for example among older adults with osteoarthritis, 27 showing variability and plasticity in older adults efforts to manage physical disability by selection, optimization, and compensation. This is highly relevant also in the perspective of preclinical mobility limitation concept. In addition to self-reported changes in the method or decreased frequency of task performance, we included also increased tiredness introduced by Avlund 15,16 into the determination of preclinical mobility limitation. Self-rated tiredness in daily activities is related to subsequent functional decline, hospitalization, and use of home help. 15,16,25 Therefore it is reasonable to take tiredness % % A B km walk.5-km walk climb up stairs 2-km walk.5-km walk climb up stairs No limitation Minor manifest limitation Major manifest limitation Fig 2. Adjusted mean differences (in percent) and their 95% CI in (A) maximal walking speed and (B) lower-extremity muscle power compared with people with preclinical mobility limitation ( level).

5 1112 PRECLINICAL MOBILITY LIMITATION, Mänty A Prevalence (%) 6 4 B Prevalence (%) 6 4 C Prevalence (%) Months Months Months No limitation Preclinical mobility limitation Minor manifest limitation Fig 3. Unadjusted prevalence (in percent) of major manifest limitation for the (A) 2-km walk, (B).5-km walk, and (C) climbing up 1 flight of stairs during 24-month follow-up. NOTE. At baseline, the number of participants with preclinical mobility limitation in 2km was 14; in.5-km walk, 1; and in climbing up stairs, 178. Respectively, the numbers for participants with no limitation was 74, 166, and 59, and for participants with minor manifest limitation 52, 36, and 58. into a definition of preclinical disability. More studies are needed to explore what aspects are relevant indicators of preclinical disability, and thus should be included in to the measurements of preclinical disability, and whether the same determination applies to different groups of older people. In our follow-up analysis, adjustment for long-term diseases and depressive symptoms attenuated the increased risk for manifest limitation somewhat among participants with preclinical mobility limitation or minor manifest limitation and a further reduction was observed when walking speed, muscle power, height and weight were added into the models. This suggests that these covariates may lie on the theoretic pathway to mobility limitation. During our 2-year follow-up, participants developed major manifest limitation most often in the 2-km walk, indicating that it was the most demanding task among the 3 mobility tasks for our participants. In our cross-sectional data maximal walking speed was more strongly associated with self-reported mobility function compared with muscle power. This was expected, as self-reported mobility limitation and objectively measured walking speed represent the same category functional limitation at the level of the organism as a whole in the disablement process. 28 Respectively, muscle power represents the impairment level of organs and body systems, being more distal from the disability category. Study s Our participants represented a group of older people who would probably benefit the most from preventive actions, because we excluded both the physically very active and those who were not able to move independently even minimally. However, the use of this truncated distribution might cause some underestimation in our cross-sectional and follow-up results. Presumably, we would have seen stronger associations if we had included also very vigorous and more impaired older people in our study. Nevertheless, our large sample size, population-based sampling, and small dropout rate underline the reliability of our results. The results of the present study have some implications to future prevention of disability, which are in line with earlier suggestions of Fried, 12,13 Wolinsky, 14 and Avlund 15,16 and colleagues. Instead of continuing the disability prevention as secondary or tertiary treatment with people already disabled, the prevention should focus on the early stages of disability. It has been suggested that in terms of maximal effectiveness, interventions for reducing or postponing disability should be targeted for people who are not yet disabled but are at high risk. 29,3 In our study the prevalence of manifest mobility Table 3: Risk Ratios and Their 95% CIs for the Onset of Major Manifest for the 2-km Walk,.5-km Walk, and Climbing Up 1 Flight of Stairs Among Participants With Preclinical or Minor Manifest Mobility, Compared With Participants With No at Baseline Activity Model I* Model II Model III RR 95% CI RR 95% CI RR 95% CI 2-km walk Preclinical limitation Minor manifest limitation km walk Preclinical limitation Minor manifest limitation Climb up 1 flight of stairs Preclinical limitation Minor manifest limitation Abbreviation: RR, risk ratio. *Model adjusted for sex and age. Model adjusted for sex and age and osteoarthritis, rheumatoid arthritis, diabetes, chronic obstructive pulmonary disease, ischemic heart disease, myocardial insufficiency, sciatica, and depressive symptoms. Model adjusted for sex and age and osteoarthritis, rheumatoid arthritis, diabetes, chronic obstructive pulmonary disease, ischemic heart disease, myocardial insufficiency, sciatica, and depressive symptoms as well as weight, height, walking speed, and muscle power.

6 PRECLINICAL MOBILITY LIMITATION, Mänty 1113 limitation in semiannual follow-up points during the 2-year follow-up was 4% to 23% among participants with preclinical mobility limitation and 28% to 52% among participants with minor manifest limitation. This indicates that people with preclinical mobility limitation are a potential target group for preventive interventions and respectively those with minor manifest limitations might already need some rehabilitative actions. This needs to be further ascertained with intervention studies focusing on preclinical mobility limitation. CONCLUSIONS The results of this study indicated that the self-report assessment tool was a valid measure to capture the early signs of disability, that is, preclinical mobility limitation. Characterizing those at preclinical stage of mobility limitation by selfreport, may serve as a simple and inexpensive tool for identifying those at high risk for future disability and would probably help to find appropriate target groups for early interventions to prevent disability. References 1. Gill TM, Williams CS, Richardson ED, Tinetti ME. Impairments in physical performance and cognitive status as predisposing factors for functional dependence among nondisabled older persons. J Gerontol A Biol Sci Med Sci 1996;51:M Guralnik JM, Simonsick EM, Ferrucci L, et al. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 1994;49:M Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 7 years as a predictor of subsequent disability. N Engl J Med 1995;332: Fried LP, Guralnik JM. 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Targeting high-risk older adults into exercise programs for disability prevention. J Aging Phys Activity 3;11: Suppliers a. University of Nottingham, Medical Faculty Workshops, Queen s Medical Centre, Nottingham, UK. b. Version 4.2; Muthén & Muthén, 3463 Stoner Ave, Los Angeles, CA 966. c. Version 9.1; SAS Institute Inc, 1 SAS Campus Dr, Cary, NC