Exercise to Reduce Mobility Disability and Prevent Falls After Fall-Related Leg or Pelvic Fracture: RESTORE Randomized Controlled Trial

The primary objective of this study was to estimate the average effect of the RESTORE program compared with usual care on mobility-related disability and rate of falls in older people aged 60 years or more with a recent fall-related lower limb or pelvic fracture.

Secondary objectives were to: estimate the average effect of the RESTORE program compared with usual care on balance and mobility, falls (proportion of fallers, type of fall, consequences of falls), fall risk (Physiological Profile Assessment tool), physical activity, walking aid use, pain, body mass index, fall-related self-efficacy, mood, self-rated health, stage of motivational readiness for change, and community participation in people aged 60+ with a recent fall-related lower limb or pelvic fracture, and to describe the safety and acceptability of the RESTORE program.

A parallel-group randomized controlled trial with equal allocation to intervention and control groups was conducted in people aged 60+ years with fall-related lower limb or pelvic fracture in the 2 years before recruitment. Ethical approval was obtained from the Northern Sydney Central Coast Human Research Ethics Committee (0905-089M) and local governance committees at the recruitment sites prior to data collection. Study recruitment was undertaken between April 2010 and November 2014. Follow-up was completed in December 2015. The study was registered in the Australian New Zealand Clinical Trials Registry (ACTRN12610000805077). The study protocol is published.²³

Participants were recruited from 11 hospitals in New South Wales, Australia. Potential participants were identified in hospital via discussion with hospital staff and review of ward lists. Permission for study staff to contact potential participants after return home was sought while they were in hospital. Letters were also sent to potentially eligible people identified from hospital databases at several of the sites. Advertisements for study participants were placed on notice boards in hospitals, community centers, and in local newspapers.

People were not eligible to participate in the study if they resided in a high-care residential facility (nursing home); had a cognitive impairment (a Mini-Mental State Examination (MMSE) score of less than 24); had insufficient English language to understand study procedures; were unable to walk more than 10 m despite assistance from a walking aid and/or another person; had a medical condition precluding exercise (e.g., unstable cardiac disease or progressive neurological disease); or were currently receiving a treatment program from a rehabilitation facility.

The intervention program is detailed in Supplementary Table 1. Two experienced physiotherapists visited participants’ homes, up to ten times in the 12-month study period, to prescribe and modify a home exercise program. Participants were asked to undertake a 20- to 30-min program of lower limb balance and strengthening exercises at least three times per week at home for 12 months. The exercises were primarily conducted while standing and were based on the Weight-Bearing Exercise for Better Balance program, available at www.​webb.​org.​au. The Physical Activity Stage of Change model²⁴ guided the physiotherapists’ approach to encouraging ongoing home-based exercise participation.

Participants also received advice about fall prevention based on the Stepping On program. Where possible, participants attended a group-based program (seven 2-h group sessions) delivered as part of the state-wide program roll-out by the New South Wales Health Department. If a participant did not wish to attend the Stepping On program, a suitable group was not available or transport to the group was too difficult, individualized fall prevention advice was given by the physiotherapist in the home visit sessions. This advice focused on safe mobility and also covered safe footwear, maximizing vision to reduce fall risk and safe medication use.

Participants in both groups received an education booklet about fall prevention and all usual care from health and community services.

Data were collected from medical records, postal questionnaires and calendars, interviews (by phone and in person), and physical assessments. Information on medical history, diagnoses, and medications were collected from medical records while participants were in hospital or from hospital discharge summaries. Baseline assessments were conducted in participants’ homes, prior to randomization and assessed demographic information and outcomes. Follow-up assessments were conducted 12 months after randomization by physiotherapists and trained research assistants who were blinded to group allocation. Participants were given calendars and questionnaires (with questions about difficulty performing mobility tasks) at the time of the baseline assessment and asked to record falls on the calendars and answer the questionnaire each month and return in pre-paid envelopes to the research center. Participants who did not return calendars or questionnaires were telephoned for the information. Participants who reported falling were telephoned to seek more information about the circumstances and consequences of the fall.

The primary outcome measures were mobility-related disability and the rate of falls over the 12-month study period. Mobility-related disability was assessed at 12-month post-randomization with three measures: (a) the performance-based Short Physical Performance Battery (SPPB); (b) the self-reported Activity Measure Post Acute Care (AM-PAC); (c) the self-reported Late Life Disability Instrument (LLDI). Using the World Health Organization’s International Classification of Functioning Disability and Health (ICF) terminology, these were measures of mobility performance, activity limitation, and participation restriction respectively.

The SPPB was measured at baseline and at 12 months after randomization. It involves the timed performance of three mobility tasks: the ability to stand for up to 10 s with feet in three positions (together side by side, semi-tandem and tandem), 4-m walk, and time to rise from a chair five times. The primary analysis was conducted using the continuously-scored version of this tool (also referred to as the lower-extremity Continuous Summary Performance Score, which uses the time taken to complete mobility tasks. Scores range from 0 (worst performance) to 3 (best performance) and are made up of a scaled score for each task.²⁵

The AM-PAC assesses difficulty with the performance of daily tasks. The computerized adaptive testing version of the AM-PAC was administered by phone at baseline, 3, 6, 9, and 12 months. This software chooses questions from an item bank on the basis of participant responses to previous questions to ensure questions asked are appropriate to the person’s level of physical functioning. The sum of the “basic mobility” and “daily activity” components was used as a primary outcome.

The Late Life Disability Instrument (LLDI), assessed at baseline and 12 months, evaluates self-reported limitations (capability) and frequency (performance) of participating in 16 major life tasks, and roles each measured on a five-point scale. The frequency and limitation dimensions are each transformed to a 0 to 100 scale, with higher scores indicating higher levels of participation.

The rate of falls was measured using monthly calendars. A fall was defined as an incident in which the body unintentionally came to rest on the ground or other lower level which was not as a result of a violent blow, loss of consciousness or sudden onset of paralysis as in a stroke or an epileptic seizure.²⁶

Secondary outcome measures were additional measures of balance and mobility (performance, self-reported activity ease, self-reported participation), additional measures of falls, fall risk, physical activity²⁸, pain, body mass index, fall-related self-efficacy, mood, self-rated health, stage of motivational readiness for change²⁹ and community outings. These measures aimed to enhance understanding of the effects of the exercise program on multiple factors that contribute to functioning and quality of life. Please see Supplementary Table 2 for information about the secondary outcome measures. Frailty, health service use, quality of life outcomes, and an economic evaluation will be reported separately.

Participants were advised to telephone study staff if they experienced any adverse effects that may have resulted from the exercise program, such as chest pain, or musculoskeletal soreness lasting for more than 48 h and interfering with daily activities or requiring medical attention.

After consent and completion of the baseline assessment, participants were formally entered into the study and randomized to intervention or control groups. Randomization order was determined using a computer-generated random number schedule with randomly permuted block sizes of 2–6. Allocation was concealed by using central randomization performed by an investigator (CS) not involved in assessments or recruitment. Treatment allocation tables were inaccessible to recruitment staff. Study staff who conducted interviews and assessments, received calendars and questionnaires, made phone calls and entered data were unaware of group allocation. Participants were instructed not to inform the assessors of their intervention status, and all exercise equipment was removed prior to the final assessment. Data analysis for the primary outcomes was undertaken blinded to group allocation.

Analyses were conducted according to the pre-defined statistical analysis plan (see supplementary file) on an intention-to-treat basis (using all available data and analyzing participants in the groups to which they were originally assigned) and were unadjusted except where indicated. For all variables, between-group differences and 95% confidence intervals were calculated. The effect of group allocation on continuous outcomes was estimated using general linear models with pre-test performance as a covariate (ANCOVA). The number of falls per person-year was analyzed using negative binomial regression to estimate the between-group difference in fall rate. Exploratory analyses investigated the rate and proportion of people experiencing indoor falls, outdoor falls, falls requiring medical intervention (i.e., local doctor visit, emergency department visit, hospital admission), falls requiring hospital admission, and falls resulting in fractures as well as the impact of controlling for exposure to physical activity (a) overall self-reported activity and (b) planned self-reported activities multiplied by days of falls follow-up as an exposure term in the negative binomial regression models). For the dichotomized secondary outcomes, log binomial regression models were used to compare the proportion of participants in each group, with baseline score as a covariate. Ordinal logistic regression²⁷ was used to compare the groups for ordinal outcomes, with baseline score as a covariate and testing of the “proportionality” assumption using the likelihood ratio test. Pre-planned sub-group analyses used interaction terms in the models to assess whether there was a differential effect of the intervention on the primary outcomes on the basis of number of past falls (0–1 versus 2 or more), cognitive impairment (1 or more adjusted errors on the Short Portable Mental Status Questionnaire (SPMSQ) versus no errors), and baseline gait speed (as a continuous interaction term and dichotomized above and below the median). Data were coded to permit blinding to group allocation in the statistical analysis of the primary outcomes. Analyses were conducted using the Stata software package, College Station, TX.

Recruitment was ceased 14 participants short of the original target due to exhaustion of study funds. Supplementary Figure 1 overviews study recruitment methods. Figure 1 shows the flow of participants through the study. Twelve-month assessment was completed by 284 participants (85% of those randomized) and data for all primary outcomes were available for 270 people (80% of those randomized).]-->

The average age of the 336 study participants was 78 years (SD 9, range 59–99) and 254 (76%) were women. Table 1 provides a summary of the baseline demographics. Baseline scores for all outcomes are shown in Tables 2 and 3. There were no important differences between the groups at baseline.

Participants randomized to the intervention group received an average of 8.4 (SD 2.9, median 10, range 0 to 13) home visits and 4.3 (SD 1.9, median 5, range 0 to 10) phone calls from the study physiotherapists. Table 4 shows the nature of the exercises prescribed, dose agreed to by participants and dose completed for the intervention group at four time points. Supplementary Table 3 shows that the exercise intervention was well received by participants. Factors limiting exercise reported by study physiotherapists and participants are shown in Supplementary Table 4. Progress on the goals set by the intervention group is shown in Supplementary Table 5.

For the primary outcome of mobility-related disability, the adjusted mean between-group difference at 12 months was 0.08 points on a 0–3 scale (95% CI − 0.01 to 0.17, p = 0.08, n = 273) for the SPPB (continuous version), 0.18 points on a 0–200 scale (95% CI − 2.89 to 3.26, p = 0.91, n = 270) for the AM-PAC, and 1.37 points on a 0–200 scale (95% CI − 2.56 to 5.32, p = 0.49, n = 273) for the LLDI. There were no statistically significant differences for these three variables. Data are shown in Table 2. During the 12-month study period, 142 people (42% of participants) experienced 260 falls (Table 5). There was no difference between the number of falls in the intervention group compared to the control group (IRR 0.96, 95% CI 0.69 to 1.34, p = 0.83, n = 336).

Between-group differences were evident in several secondary outcome measures of balance and mobility (SPPB (12-point version), single leg stance time, choice stepping reaction time, AM-PAC daily activity score at 6 months, activity difficulty at 9 months), fall risk (Physiological Profile Assessment (PPA) score), physical activity (home exercise, planned activities), mood (Geriatric Depression Scale, 6-item version), self-rated health (better than baseline), stage of motivational readiness for change, and community outings (outings to movies, etc.). These data are shown in Table 3.

Musculoskeletal problems that impaired daily activities for two or more days, or required medical attention, were reported by six participants in the intervention group: two developed Achilles tendon pain, one a skin tear from the leg colliding with a hard object while exercising, one developed pain after spine extension prior to an exercise session and was found to have a compression fracture, one developed a fracture complication, one an exacerbation of knee pain after a stepping exercise. No other adverse events were reported. Adverse events were not monitored in the control group.