N/A
N=51
Nutrition and Aerobic Exercise in Chronic Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02043574 ↗Enrolled (actual)
51
Serious AEs
5.1%
Results posted
Jan 2020
Primary outcome: Primary: The Change in Total Daily Energy Expenditure — -0.52; 32.86 change in kcal/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treadmill Exercise (Behavioral); Stretching (control) (Behavioral)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Total Daily Energy Expenditure |
-0.52; 32.86 | — |
| SECONDARY The Change in Substrate Oxidation |
0.013; 0.083 | — |
| SECONDARY The Change in Circulating Nitrotyrosine |
-24.8; -36.5 | — |
Summary
Strokes are very common in the United States and occur more in the elderly. The number of strokes is likely to double in the next 50 years. Many stroke survivors are sedentary and have a poor dietary intake, which results in abnormalities in fuel utilization (eg carbohydrate versus fat). This study will examine the effects of dietary modification and treadmill training on fuel utilization and physical function. We will study skeletal muscle oxidative stress in chronic stroke patients and the ability to employ dietary modification and exercise training to reverse these abnormalities in this ethnically diverse population.
Eligibility Criteria
Inclusion Criteria
- Veteran
- Adequate language and neurocognitive function to safely participate in informed consent, and exercise testing and training
- Under the care of a primary care medical provider.
- Age greater than 20 years
- Body mass index between 20 to 50 kg/m2
- Already completed all conventional inpatient and outpatient physical therapy.
- Ischemic or hemorrhagic stroke greater than or equal to 6 months prior.
Exclusion Criteria
- Already performing aerobic exercise 3 x / week.
- Increased alcohol consumption defined as greater than 2 oz. liquor or 2 times 4 oz. glasses of wine or 2 x 12 oz. cans of beer per day
- 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.
- Muscle Biopsy Exclusion Criteria: a) anti-coagulation therapy with heparin, warfarin, or lovenox (anti-platelet therapy is permitted), b) bleeding disorder c) allergy to lidocaine
- Medical History: a) recent hospitalization (less than 3 months prior to study entry) for severe medical disease, b) peripheral arterial disease with vascular claudication, c) orthopedic or chronic pain condition restricting exercise, d) pulmonary or renal failure, e) active cancer, f) untreated poorly controlled hypertension measured on at least 2 occasions (greater than 160/100) g) type I diabetes mellitus, untreated and / or poorly controlled diabetes with fasting blood glucose of greater than 170 and HbA1c greater than 10.0, h) medications: heparin, warfarin, lovenox, oral steroids i) currently pregnant.
- Neurological history of: a) dementia with Mini-Mental Status Score less than 23 (less than 17 if education level at or below 8th grade), and diagnostic confirmation by neurologist or psychiatrist, b) severe receptive or global aphasia which confounds testing and training, operationally defined as unable to follow 2 point commands, c) neurologic disorder restricting exercise, such as Parkinsons Syndrome or myopathy, d) untreated major depression.
Data sourced from ClinicalTrials.gov (NCT02043574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.