Resistive Training Combined With Nutritional Therapy After Stroke



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 85
Updated:3/13/2019
Start Date:August 24, 2015
End Date:June 1, 2020
Contact:Alice S Ryan, PhD
Email:Alice.Ryan@va.gov
Phone:(410) 605-7851

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Stroke survivors experience severe muscle wasting during the chronic phase of recovery, with
implications for strength, function and general health. Although resistive exercise training
effectively combats this problem, it is unknown whether sub-optimal protein intake limits the
observed gains in skeletal muscle growth. Skeletal muscle adaptations may occur when
resistive training (RT) is combined with nutritional therapy in the form of post- exercise
protein consumption. This study would be the first to directly compare RT+protein
supplementation to RT+placebo (same calories as protein supplement) in those with chronic
hemiparesis caused by stroke, providing evidence-based rationale for combination therapy in
the clinical care of this population.

The VA research team has played a prominent role in documenting the significant skeletal
muscle atrophy that accompanies chronic hemiparesis after disabling stroke. Muscle volume is
reduced by 24% in paretic vs. non-paretic legs, having significant implications for strength,
function, fitness, metabolism and general health. The investigators' previous work
establishes progressive, high-intensity resistive training (RT) as an effective
rehabilitation strategy for older stroke survivors, producing thigh muscle hypertrophy on
both the paretic and non-paretic sides. Protein supplementation can significantly augment
gains in muscle mass after RT in healthy populations, but no experiments have yet been
conducted in stroke. New preliminary data from the investigators' group indicates that stroke
participants consume 20% less protein than the recommended daily amount for older individuals
(0.80 vs. 1.0 g/kg/day) suggesting that relative gains in skeletal muscle could be
significantly better in the presence of adequate protein intake. New data also indicates that
leg muscle mass predicts resting metabolic rate (RMR) in stroke, implying that a combined
nutrition and RT therapy aimed at maximizing muscle gains would translate into improved
energy balance, a key factor in rehabilitation success. A better understanding of the true
potential for aggressive RT interventions to address stroke-related atrophy and related
problems for maximum benefit awaits clinical trials directly comparing RT with and without
nutritional therapy. The investigators propose to conduct a 12-week randomized placebo
controlled clinical trial comparing the effects of RT+ protein supplementation at 1.2
g/kg/day (RT+PRO) vs. RT+isocaloric placebo (RT+PLA) on body composition, hypertrophy,
strength, functional mobility and energy expenditure in chronic stroke.

Inclusion Criteria:

- Stroke > 3 months prior

- Completion of all regular post-stroke physical therapy

- Adequate language and neurocognitive function to participate in testing and training
and to provide informed consent

- Able to walk 10 meters without human assistance

Exclusion Criteria:

- Regular structured resistive exercise (>2x/week)

- Alcohol consumption >3oz. liquor, 3 x 4oz. glasses of wine, or 3 x 12oz beers/day, by
self report

- Neurological history of: a) dementia by clinical evaluation, b) severe receptive or
global aphasia, which confounds testing and training, operationally defined as unable
to follow 2 point commands, c) untreated major depression by clinical interview

- Medical History: a) recent hospitalization (less than 3 months prior to study entry)
for severe medical disease, b) orthopedic or chronic pain condition restricting
exercise, c) pulmonary or renal failure, d) active cancer, e) untreated poorly
controlled hypertension measured on at least 2 occasions (greater than 190/100) f)
untreated and / or poorly controlled diabetes with fasting blood glucose of greater
than 170 and HbA1c greater than 10.0, g) medications: oral steroids, h) currently
pregnant

- Cardiac history of: a) unstable angina, b) recent (less than 3 months prior to study
entry) myocardial infarction, congestive heart failure (NYHA category II-IV); c)
hemodynamically significant valvular dysfunction

- Any medical condition that, in the opinion of the Investigator, might interfere with
the subject's participation in the study, poses any added risk for the subject, or
confounds the assessment of the subject
We found this trial at
1
site
Baltimore, Maryland 21201
Principal Investigator: Alice S. Ryan, PhD
Phone: 410-605-7851
?
mi
from
Baltimore, MD
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