Online Journal Club-Article Review Template
Article Citation
Study Objective/Purpose
(hypothesis)
Brief Background (why issue is important;
summary of previous literature)
Study Design (type of trial, randomization,
blinding, controls, study groups, length of
study, follow-up)
Target Population (dx, acuity,
inclusion/exclusion criteria)
Interventions (if applicable):
(specificity of interventions, ability to
replicate, frequency, duration)
9.12.12
Background/Overview
Dal Bello-Haas V, Florence J, Kloos A, Scheirbecker J, Lopate G, Hayes S, Pioro E, Mitsumoto H. A
randomized controlled trial of resistance exercise in individual with ALS. Neurology. 2007;68:20032007.
To compare the effects of resistance exercise versus usual care in patients with early-stage
Amyotrophic Lateral Sclerosis (ALS).
The role of exercise in people with ALS is controversial, and the possibility of inducing overwork
damage through excessive exercise or strengthening is a concern. Two early case studies reported
resistance exercise had positive effects on people with ALS, along with significantly less decline in
ALS Functional Rating Scale (ALS-FRS) and Ashworth Spasticity scores. Animal studies also show
some benefits with low to moderate intensity exercise.
Methods
Randomized Controlled Trial
Control group: received usual care (stretching)
Experimental group: resistance exercise plus usual care
Subjects were not blinded
Monthly evaluations were performed by experienced, blinded therapists
Duration: 6 months
Target population: patients with early-stage ALS
Inclusion criteria: early-stage ALS (stage 1 or 2) as determined by Sinaki and Mulder staging criteria;
mild to moderate weakness in a certain few muscles; able to perform daily activities with no or mild
limitations; FVC >90% of predicted; ALS-FRS of >30
Exclusion criteria: patients enrolled in ALS pharmaceutical trial; history of neuromuscular dysfunction
not related to ALS; concomitant medical problems that would pose a safety problem or would interfere
with ability to participate; those who were unwilling or unable to comply with protocol
Individualized UE and LE moderate-load and moderate-intensity resistance exercise program
(per patient tolerance and limitations)
 Targeted muscle groups: those greater than or equal to 3/5 (all others only received usual care)
 Resistance Groups: stretching program (as detailed below), plus 3 sets of 5 reps, at 6RM, 3x/week
(did not perform 1RM testing due to risk of muscle damage)
o Utilized Oxford technique: 1st set = 100%, 2nd set = 75%, and 3rd set = 50% of 6RM to avoid
over-fatiguing
o Muscle groups: UE: shoulder flexors, shoulder abductors, shoulder extensors, elbow flexors
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Outcome Measures (relevant to purpose of the
study; reliable, valid, clinical utility)
Statistical Analysis (statistics used,
appropriate application)
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Enrollment/Subject Characteristics (sample
size, gender, age, functional level; were
groups similar on important variables prior to
application of the intervention)
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Summary of Primary and Secondary
Outcomes (include aggregate and sub-group
findings if reported); note results that were
statistically significant; How many reached a
level of clinical significance (exceed MCID if
known); Was there retention of changes
following intervention (if studied)
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Brief Summary of Authors’ Main Discussion
Points; Authors’ Conclusion
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and extensors, LE: hip flexors, hip extensors, knee flexors, knee extensors, and ankle DFs
Usual Care: stretching of bilateral quads, hamstrings, gastrocnemius, ankle DFs, and UE shoulder
flexors, extensors, adductors and abductors; instructions/dosage: 5x30sec each, 1x/day
Written instructions, diagrams, and tracking logs were provided for each group
ALS-Functional Rating Scale, Fatigue Severity Scale (FSS), Short Form 36,
MVIC, and FVC (latter two were utilized to monitor for signs of adverse effects of exercise)
Kolmogorov-Smirnov test of normality was non-significant for all variables except for baseline SF36
Wilcoxon Rank Sum for the R-P subscales of the SF-36
t-test for outcome measures at 3 and 6 months
t-test, X^2 or Fisher exact test for baseline characteristics
p<0.05 was considered significant
Intention to treat analysis did not show a difference between the groups
Results
27 patients were randomly assigned: 13 to resistance exercise group, 14 to usual care group
Resistance group: 11 participants were analyzed at 3 months, and 8 participants were analyzed at 6
months
Usual care group: 14 participants were analyzed at 3 months, and 10 participants were analyzed at
6 months
There were no differences in demographic and other variables between groups, although there was
a trend toward a worse SF-36 physical functioning score in the usual care group
At 3 months: the resistance exercise group had a significantly higher ALS-FRS score
At 6 months: the resistance exercise group had significantly higher ALS-FRS scores and SF-36
physical function subscale scores
Less decline in leg strength: measured by MVIC was found in the resistance exercise group
No adverse events related to intervention occurred in either group, as indicated by MVIC and FVC
No difference was found in FVC at 3 or 6 months
Authors’ Discussion and Conclusions
Per author: we have observed clinically that moderate resistance exercise programs implemented
early can reduce the complications associated with disuse atrophy
No adverse effects were found with resistance exercise, as previously thought
Resistance exercise may be an essential component of the overall care of the patients with this
disease, despite the poor prognosis
Reviewer’s Discussion and Conclusion
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Study Strengths
Study Limitations and
Potential for Bias
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RCT
Six-month follow up (difficult to obtain given nature of disease progression in this population)
Sample size and subsequent difficulty of recruiting and retaining subjects in this population given
diagnosis and disease progression
FSS may not be sensitive enough to detect change in our ALS population, however both groups
had higher fatigue scores by 6 months
Exercises were completed at home only
Study didn’t report survival rate
5/13 of the resistance group and only 2/14 in the usual care group were taking Riluzole
Patients in early stages of ALS
Outpatient vs. Home therapy
Guidance for exercise prescription for other neuromuscular disorders (NMDs) in regards to
avoiding over-fatigue
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Applicability:
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 Types of patients (dx) that results apply to 
 Types of settings or patient acuity that the 
results apply to
 Can interventions be reproduced? Can
results be applied to other pt populations?
How will study results impact PT
Patients with ALS who participate in an exercise program may have a greater sense of control over
management of this patient population?; List
what is happening to their bodies. This could increase their sense of autonomy in regards to their
suggestions for how to implement changes in
healthcare, especially given their limited lifespan.
your clinic/department to integrate study
In regards to Physical Therapy management and our evolving healthcare system, this study may
findings into patient care
support the trend towards visiting your Physical Therapist once a month, with utilization of online
check-ins to monitor and adjust treatment as needed.
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