Journal of Aging and Physical Activity, 2009, 17, 294-306
© 2009 Human Kinetics, Inc.
Should Physical Activity Programs
Be Tailored When Older Adults Have
Anthony P. Marsh, Elizabeth A. Chmelo, Jeffrey A. Katula,
Shannon L. Mihalko, and W. Jack Rejeski
The purpose of this study was to determine whether a walking program supplemented
by tasks designed to challenge balance and mobility (WALK+) could improve physi-
cal function more than a traditional walking program (WALK) in older adults at risk
for mobility disability. 31 community-dwelling older adults (M ± SD age = 76 ± 5 yr;
Short Physical Performance Battery [SPPB] score = 8.4 ± 1.7) were randomized to
treatment. Both interventions were 18 sessions (1 hr, 3/wk) and progressive in
intensity and duration. Physical function was assessed using the SPPB and the 400-
m-walk time. A subset of participants in the WALK group who had relatively lower
baseline function showed only small improvement in their SPPB scores after the
intervention (0.3 ± 0.5), whereas a subset of participants in the WALK+ group with
low baseline function showed substantial improvement in their SPPB scores (2.2 ±
0.7). These preliminary data underscore the potential importance of tailoring inter-
ventions for older adults based on baseline levels of physical function.
Keywords: walking, exercise, frailty, mobility, balance
Regular physical activity is important in the disablement process because it
improves cardiovascular function, muscle strength, and balance, which in turn
might delay the onset of function limitations and mobility disability (The LIFE
Study Investigators, 2006; Lord, Ward, Williams, & Strudwick, 1995; Nelson
et al., 2004, 2007; U.S. Department of Health and Human Services, 1996). Mobility
disability dramatically increases the risk of dependency (Hirvensalo, Rantanen, &
Heikkinen, 2000), which is not surprising given the critical role of mobility in
activities of daily living (Frank & Patla, 2003).
Walking is the most common mode of physical activity in older adults (Di
Pietro, 2001; Eyler, Brownson, Bacak, & Housemann, 2003), but it has been sug-
gested that traditional walking interventions lack the perceptual and decision-
making complexity of real-world environments (Frank & Patla, 2003). Frank and
Patla suggest a number of tasks that could be integrated into a walking program to
challenge vision, balance, and mobility. In addition, although moderate-intensity
The authors are with the Dept. of Health and Exercise Science, Wake Forest University, Winston-
Tailoring Activity in Older Adults 295
walking by itself can improve physical function (Buchner et al., 1997; Moore-
Harrison, Speer, Johnson, & Cress, 2008), adding tasks that challenge specific
functional capacities such as balance and strength might augment improvements
in physical function and mobility. For that reason, multimodal exercise programs
are recommended in guidelines for physical activity in older adults (Cress et al.,
2005; Nelson et al., 2007; Paterson, Jones, & Rice, 2007) and have been used suc-
cessfully to improve outcomes focused on physical function and mobility in older
adults (Baker et al., 2007; The LIFE Study Investigators, 2006; Nelson et al.,
A large number of studies conducted in older adults have compared different
modes of exercise with a control, but few studies have been done comparing walk-
ing with an alternative or novel intervention. For example, Rooks, Kiel, Parsons,
and Hayes (1997) showed that both resistance training and walking improved
tests of static balance and stair-climbing speed. This study is notable because both
interventions were entirely self-paced, in contrast to being highly structured. Li,
Fisher, and Harmer (2005) reported that 16 weeks of “cobblestone” mat walking
improved functional reach, static balance, chair stands, and 50-ft-walk speed and
reduced blood pressure to a greater extent than conventional walking in adults age
60–92 years. Recently, Shigematsu et al. (2008) showed that a novel stepping
intervention improved a number of lower extremity functional outcomes com-
pared with a walking intervention. There is a gap, however, for studies that have
compared a walking program with an exercise intervention that combines both
walking and challenging balance and mobility tasks in older adults at risk for
Although the evidence is sparse the data suggest that older adults’ functional
ability will influence their response to exercise training. For example, Gill et al.
(2002) reported a significant beneficial effect in preventing functional decline
using a home-based exercise program in a group of older adults with moderate
frailty but no effect among those with severe frailty. In contrast, Chandler, Duncan,
Kochersberger, and Studenski (1998) found that the impact of 10 weeks of resis-
tance exercise on chair-rise performance was significant in participants who were
more impaired. With respect to falls, a meta-analysis by Robertson, Campbell,
Gardner, and Devlin (2002) showed that a subgroup of adults age >80 years who
had experienced a fall benefited the most from a program of muscle strengthening
and balance retraining. Recently, Faber, Bosscher, Chin, and van Wieringen (2006)
showed that there were differential effects of two interventions, one based on
mobility activities and one based on Tai Chi, such that frail older adults did not
respond whereas prefrail older adults showed significant improvements in physi-
cal function. Similarly, Luukinen et al. (2006) reported that although exercise in
very old adults (>85 years) appears to delay loss in mobility, this was not true in a
subset of their sample with severe dysfunction in movement or activities of daily
living. Therefore, it is not always the case that older adults with the lowest func-
tion have the greatest potential for improvement with exercise training, although
this has been observed previously (Baker et al., 2007). Rather, those with very low
function might have reached a point where their disability cannot be treated effec-
tively with traditional exercise interventions (Gill et al.). More work is needed to
identify exercise interventions that can improve physical function and mobility in
older adults with low function.
296 Marsh et al.
To emphasize that older adults have unique and varied needs depending on
their functional status and health, the American College of Sports Medicine pub-
lished new guidelines for this segment of the population (Nelson et al., 2007).
Adults over the age of 65 are encouraged to engage in moderately intense aerobic
exercise for at least 30 min a day, 5 days a week, and to supplement this activity
with balance exercises to reduce the incidence of falls (Nelson et al., 2007). There-
fore, it would seem appropriate to design walking programs that include activities
to challenge multiple domains such as mobility and balance, to better mimic the
complexity of real-world settings that older adults encounter as they move about
in their daily lives. Therefore, among older adults at risk for mobility disability,
the purpose of this study was to test the hypothesis that a physical activity pro-
gram supplemented by tasks designed to challenge mobility and balance (WALK+)
would improve physical function to a greater extent than a traditional walking
We recruited participants from a database of older adults interested in clinical
trials who (a) were 65–85 years of age, (b) were not participating in a regular
physical activity program (i.e., any moderate or strenuous activity lasting ≥30
min/session, ≥3 days/week), (c) scored ≤10 on the Short Physical Performance
Battery (SPPB; Guralnik et al., 1994), (d) scored ≥6 on the Pfeiffer Mental Status
Scale (Pfeiffer, 1975), (e) had no progressive or debilitating conditions that would
limit participation in exercise, and (f) had received their physician’s approval.
Within this sample, we classified individuals as either low or high function based
on their baseline SPPB score; low function was classified as an SPPB score of 3–8
and high function was classified as an SPPB score of 9–10. One of the goals of
this exploratory study was to obtain data to estimate the effects of each interven-
tion because there are no data in the literature that match the outcomes and inter-
ventions used in the current study. This study was approved by Wake Forest Uni-
versity’s institutional review board, and all participants signed an informed
consent before their participation.
We had a two-person assessment team who were blinded to treatment and trained
by the primary author on all outcomes. They completed most baseline and follow-
up assessments. Occasionally a third individual helped collect the outcomes, and
she was not blinded. We acknowledge this as a limitation of the study; however,
any bias is mitigated by the fact that all outcomes were administered using pre-
pared scripts. Furthermore, both the SPPB and the 400-m walk are objective mea-
sures of physical function, which reduces the potential for bias on the part of the
The SPPB (Guralnik et al., 1994) is a standardized measure of physical per-
formance that assesses standing balance, usual gait velocity over a 4-m course,
and the time to sit down and rise from a chair five times as quickly as possible.
Tailoring Activity in Older Adults 297
Each task is scored on a scale of 0–4, with 0 indicating the inability to complete
the task and 1–4 indicating the level of performance. The total SPPB score rang-
ing from 0 (lowest function) to 12 (highest function) was calculated by adding the
scores for the three components. The SPPB scale predicts institutionalization,
hospital admission, mortality, and disability and is widely used to identify older
individuals with compromised levels of lower extremity function who are at risk
for mobility disability (Ferrucci et al., 2000; Guralnik, Ferrucci, Simonsick,
Salive, & Wallace, 1995; Guralnik et al., 1994; The LIFE Study Investigators,
2006; Onder et al., 2002). Intraclass correlation coefficients for the SPPB range
from .88 to .92 for measures made 1 week apart (Ostir, Volpato, Fried, Chaves, &
For the 400-m walk, participants were timed while they walked 10 clockwise
laps around a 40-m indoor course as quickly as possible without sitting, using an
assistive device (including a cane), or the help of another person (Rolland et al.,
2004). A script was used to provide identical instructions to all participants. The
script was as follows: “You will be walking 10 complete laps around the course,
about 1/4 mile. Please walk as quickly as you can, without running, at a pace you
can maintain over the 10 laps. After you complete the 10 laps, I will tell you to
stop.” On each lap the assessor offered standard encouragements (“Keep up the
good work.” “You are going well.” “Looking good.” “Well done.” “Good job.”)
and told the participant the number of laps completed and the number remaining.
Participants were allowed to rest in place and given a maximum of 15 min to
complete the 400-m walk.
At baseline, participants completed the informed consent; the SPPB; a self-
administered questionnaire consisting of demographics, health history, and psy-
chosocial questions; and a 400-m walk. After baseline testing, they were random-
ized using a table of random numbers to either the WALK (n = 15) or the WALK+
(n = 16) group. Follow-up testing was completed within a week after the comple-
tion of the intervention.
Participants in each group attended a 1-hr session, three times a week, at an
indoor exercise facility. With only a few exceptions the intervention was com-
pleted in 6 weeks; in the event of a missed session (e.g., because of illness, vaca-
tion, or schedule conflict), a makeup session was scheduled so that all participants
completed 18 sessions. Both intervention groups exercised in small groups at
separate times of the day. Therefore, the WALK group did not see or interact with
the members of the WALK+ group, nor did they observe any of the equipment
used in the WALK+ intervention. The WALK and WALK+ groups were super-
vised at all times by a lead interventionist with ACSM exercise specialist certifica-
tion. She was assisted by a graduate student and several undergraduate students
with training in exercise science. Neither interventionist discussed the other inter-
vention with participants, and participants were instructed to continue with their
normal routine outside of the intervention sessions.
Both interventions were progressive in intensity and duration. Because of the
varied functional abilities of our sample, a standardized progression for the walk-
ing program was not feasible. For example, at the start of the intervention not all
participants could walk for 25 min either continuously or with rest stops, and not
all participants could walk at or near a rating of perceived exertion (RPE) of
11–13. Therefore, in the first one or two sessions we assessed each participant’s
298 Marsh et al.
capabilities and then encouraged him or her to increase the duration and/or inten-
sity over the course of the intervention. The goal was to reach or approach 25 min
of continuous walking in the case of the WALK group or continuous walking
interspersed with the “plus” component for the WALK+ intervention, walking at
an intensity comparable to an RPE of 11–13. The interventionists played a key
role in tracking each participant’s previous efforts and setting a goal for each sub-
sequent exercise session.
Each participant walked two laps at a low intensity before walking for up to 25
min at a moderate-intensity walking pace—RPE of 11–13 on the Borg Scale
(Borg, 1973). Heart rate, blood pressure, and RPE were recorded at the midexer-
cise time point. After the walking bout, participants completed two laps at a slow
walking pace and 20 min of stretching and flexibility exercises for major muscle
Participants in the WALK+ followed a walking protocol similar to that of the
WALK, but they were instructed to complete four obstacle stations as they encoun-
tered them along the track. The total time of the walk/obstacle session was a maxi-
mum of 25 min of which 8–10 min were devoted to the obstacle stations. After the
walk/obstacle phase, participants completed two laps at a slower pace and 10 min
of flexibility exercises. At the end of every week, an investigator (EC) evaluated
each participant to determine mastery over a progression. Each participant was
required to complete a minimum of three sessions at each progression. The same
investigator (EC) observed each participant over two sessions. If participants
could complete the progression with no apparent difficulty, assessed by speed and
stability of movement, the investigator allowed them to progress to the next level.
If participants did not feel they could confidently progress to the next level they
were not required to do so.
Balance. Progression 1 (P1) balance testing consisted of standing on a square
foam pad (AIREX, M-F Athletic, Cranston, RI) for 10 s with feet shoulder width
apart. The participants were given the option of standing on one foot on the foam
pad once they had mastered the first progression. This task was completed before
each progression. Then the participants walked for 3 m between two lines that
were approximately 6 in. apart. Progression 2 (P2) testing consisted of walking
heel to toe on a line at a self-selected pace for a distance of 3 m. Progression 3 (P3)
testing consisted of walking on a 3.25-m-long foam balance beam (AIREX, M-F
Athletic). Progression 4 (P4) testing consisted of walking heel to toe on the foam
balance beam. Progression 5 (P5) consisted of walking with the feet on separate
foam balance beams approximately 0.5 m apart.
Hurdles. P1 hurdles testing consisted of walking over five white lines ~1 m
apart drawn on the track without stepping on the lines. P2 testing consisted of
walking over six 6-in. hurdles placed ~1 m apart (db Manufacturing, Middleton,
WI). P3 testing consisted of P2 plus walking over a 6-in. hurdle, ducking under a
Tailoring Activity in Older Adults 299
4-ft hurdle, stepping over another 6-in. hurdle, and ducking under another 4-ft
hurdle. P4 testing consisted of the same as P2 but walking laterally. P5 testing
consisted of laterally traversing over the P3 obstacles while alternating direc-
tions—moving laterally stepping over hurdle, turning 180°, ducking under high
hurdle, turning 180°, stepping a over hurdle, turning 180°, and ducking under the
final high hurdle.
Cones. P1 cones testing consisted of walking over a crooked stick obstacle (db
Manufacturing, Middleton, WI) placing one foot on each side of the stick, alter-
nating feet and avoiding stepping on the stick. P2 testing consisted of zigzagging
around six cones ~1 m apart. P3 testing consisted of walking through the P2
course carrying a dumbbell weight in each hand. P4 testing consisted of walking
down and back over the crooked stick crossing feet over one another (i.e., grape-
vine maneuver). P5 testing consisted of doing P4 while carrying a dumbbell in
Walking Trails A and B. The Walking Trails task was a modification of a task
described by Alexander, Ashton-Miller, Giordani, Guire, and Schultz (2005). In
Trails A participants stepped on numerically ordered rubberized circular discs,
numbered 1–25. The numbers were spread out, in order, about a step apart within
a 2-m-wide by 4-m-long rectangle such that participants walked 12 circles down
and 13 circles back. In Trails B participants walked from a number to a letter
(1-A-2-B-3-C-4- . . . -L-13).
Statistical analyses were performed using SPSS version 14.0 (SPSS Inc., Chi-
cago). Analysis of covariance (ANCOVA) was used to examine group differences
in the SPPB and 400-m-walk change scores, with the pretest scores being used as
covariates in each analysis. To examine whether baseline levels of function mod-
erated the treatment effect in these analyses, we constructed an interaction term by
multiplying the baseline scores for function by group assignment. Because of the
reduced power of testing interactions in linear models and the exploratory nature
of this research, the alpha level for both interaction terms was set at the p < .10
level. We explored interpretation of significant interaction terms by creating a
dichotomous variable for baseline function scores within our sample and crossing
this variable with group assignment. The dichotomous variable for lower extrem-
ity function was created by assigning a 1 (low function) to individuals with a
baseline SPPB score of 3–8 and 2 (high function) to individuals with a baseline
SPPB score of 9–10.
Ten male and 21 female community-dwelling older adults were recruited for this
study. The mean (± SD) age of the participants was 76 ± 5 years (range 67–85),
with a mean body-mass index (BMI) of 29 ± 5 kg/m2 (range 19–39) and SPPB
score of 8.4 ± 1.6 (range 3–10). There were no significant differences between the
WALK and WALK+ group in any demographic or health measure at baseline
(Table 1). One participant from the WALK group and 1 from the WALK+ group
300 Marsh et al.
dropped out of the study for reasons unrelated to the intervention (previously
undocumented dementia and preexisting brain aneurism). Therefore, 29 individu-
als completed the interventions, 14 in the WALK group and 15 in the WALK+
group. There were no exercise- or testing-related adverse events.
There were no significant differences between the WALK and WALK+ group
in any outcome measure at baseline (Table 1). In the ANCOVA examining change
scores in SPPB, there was a significant group main effect, F(1, 25) = 4.73, p =
.039. Paired t tests (two tailed) conducted within each group on the baseline and
follow-up SPPB score showed that both groups increased their SPPB score after
the intervention, but only the WALK+ group difference was statistically signifi-
cant, WALK 8.1 ± 1.4 to 8.8 ± 2.0, t(13) = –1.93, p = .075, WALK+ 8.7 ± 1.8 to
Table 1 Baseline Characteristics Including Physical-Function
Outcome Measures of the Participants
Number of participants
Number of men/women
Body mass, kg
Body-mass index, kg/m2
Ethnicity, n (%)
Education, n (%)
Marital status, n (%)
Comorbidities, n (%)
400-m walk (s)
8.2 ± 1.5
403.4 ± 124.2
8.7 ± 1.8
372.0 ± 115.0
Note. COPD = chronic obstructive pulmonary disease; SPPB = Short Physical Performance Battery.
Data are M (SD) unless otherwise noted. There were no significant differences between the groups at
Tailoring Activity in Older Adults 301
10.0 ± 1.4, t(14) = –3.57, p = .003. Interpretation of this main effect is qualified by
a significant interaction term, F(1, 25) = 3.59, p = .07. Recall that to accommodate
interpretation of significant interaction terms we created a dichotomous variable
for function, relative to our sample (low vs. high), and crossed this with the treat-
ment variable (WALK vs. WALK+); these cell means can be found in Table 2.
Follow-up tests revealed that this interaction resulted from differences in the
SPPB change scores between individuals with low baseline function assigned to
either the WALK or WALK+ intervention, F(1, 12) = 5.38, p = .039. The esti-
mated means suggest that participants with low baseline function assigned to the
WALK group showed only small improvement in their SPPB score after the inter-
vention, whereas those with low baseline function assigned to the WALK+ group
showed substantial improvement in their SPPB score. There was no significant
difference between the WALK and WALK+ groups in change scores for the 400-
m-walk data, F(1, 25) = 2.11, p = .16.
To calculate estimates of effect sizes (ES) for the SPPB and 400-m walk, we
used the estimated marginal means (i.e., least-squares means), obtained from an
ANCOVA on change scores that controlled for baseline score. For the SPPB
change scores, the least-squares means were 0.6 for WALK and 1.4 for WALK+,
indicating improvement in lower extremity function, with a common SD of 1.3.
The ES was .6, which is moderate. For the 400-m-walk change scores, the least-
squares means were –13.5 s for WALK and –17.8 s for WALK+, indicating a
faster walk time, with a common SD of 26.4 s. The ES was .2, which is low.
Given the exploratory nature of this study, we also examined changes in the
three components of the SPPB, using an ANCOVA that controlled for baseline
differences between the groups, and used the change score as the outcome. Recall
that each component of the SPPB is scored 0–4. There was a significant difference
between the WALK and WALK+ groups in balance change score, raw M ± SD for
WALK and WALK+ of 0.1 ± 0.6 and 0.3 ± 0.9, respectively, F(1, 26) = 6.02, p =
.021. There were no significant group differences for change scores for gait speed
(0.4 ± 0.6 vs. 0.4 ± 0.5) or chair rises (0.3 ± 1.0 vs. 0.6 ± 1.0), but the trends in the
means indicate improvement in both of these components for both groups.
Table 2 Estimated Marginal Means and Standard Errors for Change
in Short Physical Performance Battery (SPPB) and 400-m-Walk Time
WALK, n = 10
WALK+, n = 5
WALK, n = 4
WALK+, n = 10
Change in SPPBa
Change in 400-m walk (s)
aBaseline Function Group interaction was significant, p = .046. bSignificant difference between
WALK and WALK+ for low in change in SPPB, p = .039.
302 Marsh et al.
This study compared the effects of a walking program that integrated complex
tasks designed to challenge mobility and balance (WALK+) with a traditional
walking program (WALK) on physical functioning in older adults with compro-
mised lower extremity function. There was evidence from the SPPB scores that
participants with lower physical function at baseline benefited more from the
WALK+ program than the WALK program. This was not true for older adults with
higher levels of baseline function; although the results did not exceed conven-
tional levels of statistical significance, there was a trend for the higher functioning
older adults to benefit more from WALK than WALK+. Although these findings
are limited by the small number of participants in the study, which reduced the
power to detect differences between groups, they do suggest that tailoring treat-
ment might be particularly important in older adult populations. This finding is
consistent with the recent guidelines published by Nelson et al. (2007). In particu-
lar, older adults with low function might need to improve balance and mobility
skills first to subsequently reap the benefits of a standard walking program.
Although several studies suggest that frail older adults might derive limited
or no benefit from an exercise program (Faber et al., 2006; Gill et al., 2002; Luuki-
nen et al., 2006), the older adults with very low function did benefit from a pro-
gram of walking combined with balance and mobility tasks. It is important to
acknowledge that the program we implemented might not be applicable to older
adults who cannot walk short distances or who have SPPB scores of 0–2. In par-
ticular, very frail older adults might be at increased risk for falls in the absence of
adequate intervention-staff supervision, which might, in some cases, involve one-
on-one interaction. This is likely a reality of any intervention that focuses on
mobility and balance in very frail individuals.
The concept of tailoring an intervention to the needs of an individual or a par-
ticular subgroup is not new (Brawley, Rejeski, & King, 2003; Heath & Stuart,
2002; King, Carl, Birkel, & Haskell, 1988; Singh, 2002). The stepped approach of
the levels at three of the four stations and the individualized prescription of the
walking program that we used in this study are consistent with this practice. The
data suggest that the balance and mobility challenges offered by the four stations
were important to the improvement of the subsample of low-functioning older
adults. It is worth mentioning that although two thirds of the 15 participants reached
the fifth (highest) level of the hurdles-and-cones stations, only 1 individual reached
the fifth progression of the balance station by the end of 18 sessions. Six individu-
als did not progress beyond the third progression at the balance station, and 2
individuals only made the third progression on the hurdles-and-cone stations.
Anecdotally, the Walking Trails A/B station was very taxing for most participants,
who appeared to have difficulty maintaining stability while planning their next
The trends in the 400-m-walk data are interesting in that less time was spent
walking in the WALK+ intervention because participants had to integrate the four
stations within the fixed 25-min time period of the intervention. Overall, the within-
group trends observed suggest that the walking component of both the WALK and
WALK+ interventions was effective. However, the ES related to the difference
between the groups in 400-m-walk change scores was low (.2). The low-functioning
Tailoring Activity in Older Adults 303
participants in the WALK+ intervention did appear to benefit in spite of the reduced
time spent on the cardiovascular component of the intervention. Preserving the
ability to walk 400 m is important for a wide variety of daily and social activities
that only require walking this modest distance (Hadley, 2007). Losing the ability to
walk 400 m forces an older adult to either resort to compensatory strategies that
might pose social or financial burdens or to restrict the scope of their daily lives.
Relative to changes in SPPB, the lower functioning participants in the WALK+
condition experienced the most change (M = 2.2 points), whereas the lower func-
tioning participants in the WALK condition experienced the least change (M = 0.3
points). Perera, Mody, Woodman, and Studenski (2006) examined the magnitude
of meaningful change in several measures of lower extremity function and con-
cluded that a 0.5-point change in SPPB score is a small meaningful change and a
1-point change can be considered substantial. The changes we observed in the
SPPB are encouraging given the short duration of the intervention. Overall, the ES
related to the difference between the groups in SPPB change scores was moderate
The analyses of the three components of the SPPB are consistent with the fact
that the stations included in the WALK+ intervention place a premium on an indi-
vidual’s ability to maintain stability. The data suggest that the balance component
of the SPPB improved more in the WALK+ group than in the WALK group. The
improvement in balance might also be responsible for the trend observed in the
chair stands. It is important to recognize that all three components of the SPPB
showed trends for improvement after the interventions. An interesting question is
whether a similar result would have occurred by simply completing the four sta-
tions without any walking component.
The changes observed in the SPPB are important because this outcome is
predictive of disability, mortality, and institutionalization (Guralnik et al., 1994).
Our data show that the SPPB might be useful in discriminating between older
adults in need of tailored interventions and those needing only to increase their
level of physical activity. This might be useful for physicians in clinical decision
making about physical activity for older patients. In addition, it is encouraging
that the WALK+ intervention appeared to offer measurable advantages over a
standard walking program, a comparison that is more rigorous than one using a
nonexercise control. Finally, the results and conclusions of this study should be
viewed in the context of several limitations. The primary limitation was the small
sample size, which reduced the power to detect differences between the groups.
Second, we did not stratify the randomization by baseline function. Finally, as
discussed previously, an unblinded investigator assisted with some outcome
assessments, which introduced the potential for bias. Additional research is needed
to replicate these findings using larger samples, to study long-term interventions,
and to determine whether the benefits demonstrated here translate to other forms
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