Stroke Clinical Trial
Official title:
The Effect of Creatine Supplementation and Resistance Training in Stroke Survivors
Creatine monohydrate is important for sustaining phosphocreatine stores in tissues such as muscle and brain. Phosphocreatine is an important source of energy in these tissues. Supplementation with creatine monohydrate is effective in healthy and clinical populations for improving muscle and brain function. The purpose of our study is to determined whether creatine supplementation is effective during resistance training for improving muscle and brain function in people recovering from stroke.
The purpose of this study is to determine the effects of creatine supplementation and
supervised resistance training in stroke survivors. It is hypothesized that creatine
supplementation and resistance training will increase whole-body lean tissue mass, limb
muscle thickness, muscle strength, tasks of functionality and cognition and decrease symptoms
of depression and anxiety compared to placebo and resistance training.
Stroke is characterized by an abrupt disturbance in cerebral circulation causing a
neurological deficit. It is a major cause of adult neurological disability in North America,
often resulting in significant muscle loss, weakness and functional limitations. Disability
associated with stroke limits independent living and social participation in at least half of
all stroke survivors. A sedentary lifestyle after stroke can increase the risk for recurrent
stroke, cardiovascular disease, and diabetes mellitus. All factors may adversely affect
independence and quality of life. The majority of stroke survivors have residual impairments
such as hemiparesis, spasticity, cognitive dysfunction, and aphasia, with full recovery
reached in a small portion of these individuals. One of the major consequences of these
impairments is physical inactivity which inevitably contributes to muscle loss, decreased
muscle function (i.e. strength, endurance) and impaired functionality. One intervention which
may help improve muscle mass, muscle function and functionality in stroke survivors is
supervised resistance training. Resistance training does not lead to muscle spasticity in
stroke survivors and has been shown to improve the ability to perform activities of daily
living. Another intervention which may be beneficial for stroke survivors is creatine
supplementation. Creatine has been shown to increase muscle mass, muscle function and tasks
of functionality when combined with resistance training, possibly by influencing cellular
hydration status, high-energy phosphate metabolism, muscle protein kinetics, satellite cells,
anabolic growth factors, and inflammation. Creatine has also shown promise for improving
cognition and symptoms of depression and anxiety; however, no study has examined the combined
effects of creatine supplementation and resistance training in stroke survivors.
The study will be a double-blind, repeated measures design. In order to minimize group
differences, participants will be matched according to age, gender, and type of stroke and
then be randomized on a 1:1 basis to one of two groups, creatine monohydrate or placebo
(corn-starch maltodextrin). Creatine and placebo will be similar in taste, color, texture and
appearance. A research assistant will be responsible for randomization and another research
assistant will prepare study kits. Each study kit will contain the participants supplement
for the duration of the study, detailed supplementation instructions, as well as measuring
spoons. For days 1-7, participants will ingest 0.3g/kg of creatine or placebo (0.075 g/kg x 4
times daily). This creatine dosing strategy has been shown to be effective for increasing
intramuscular creatine stores. For subsequent days, participants will consume 0.1 g/kg/day of
creatine or placebo as this creatine dosage is effective for increasing muscle mass. On
training days, participants will consume their supplement within 5 minutes after each
training session. On non-training days, supplements will be consumed at the participants
leisure. Adherence with creatine supplementation, placebo, and resistance training will be
assessed by training and supplementation compliance logs. A retrospective treatment
identification will be administered to all participants upon completion of the study in order
to assess whether participants thought they were administered creatine, placebo, or unsure
about what supplement they consumed.
The dependent variables that will be measured at baseline and after the intervention include:
(1) whole-body lean tissue mass (dual energy x-ray absorptiometry) (2) muscle thickness
(elbow and knee flexors and extensors; ultrasonography), (3) muscle strength (1-repetition
maximum leg press and chest press), (4) tasks of functionality (berg balance scale, 6-minute
walk test) (5) cognition (Montreal Cognitive Assessment), (6) depression (The Center for
Epidemiologic Studies- Depression Scale) and anxiety (Generalized Anxiety Disorder 7-item).
Participants will also complete a 3-day food log at baseline and during the last week of
supplementation and training to determine whether total calories consumed as well as
macronutrient intake changed over the duration of the study. Participants will be instructed
to record all food and beverages consumption during these 3 days. Food records will be
analyzed using MyFitnessPal.
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