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Nutrition and Aerobic Exercise in Chronic Stroke (NEXIS)

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ClinicalTrials.gov Identifier: NCT02043574
Recruitment Status : Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Treadmill Exercise Behavioral: Stretching (control) Not Applicable

Detailed Description:
In acute stroke settings, it is known that energy imbalance is associated with poorer rehabilitation and functional outcomes, and importantly, increased risk of institutionalization. However, nutrition and eating habits of chronic stroke rehabilitative care have received very little consideration, especially if the survivor is living in a free living environment. Studies have shown deficiencies in energy and protein intake versus recommendations in chronic stroke survivors. Perry et al. found ~7% of chronic stroke survivors were at moderate and ~5% at high nutritional risk. Although little is known regarding total daily energy expenditure and dietary intake in chronic stroke, energy and macronutrient imbalance may have a profound impact on stroke recovery and risk of development of chronic disease and recurrent stroke by altering substrate oxidation and result in systemic and tissue level oxidative stress. Conversely, cardiovascular disease risk increases with excess calorie and fat intake and two-thirds of stroke survivors are overweight or obese. In obese, non-stroke populations, energy dense, high fat meals are associated with increases in plasma oxidative stress markers. Oxidative stress can lead to mitochondrial damage and abnormal accumulation of metabolite intermediates and lipid accumulation in non-adipose tissues, which can impair heart function, increasing CVD and stroke recurrence risk.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects are randomized to either stretching or treadmill training.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aerobic Training to Improve Energy Utilization and Antioxidant Capacity in Stroke
Actual Study Start Date : November 17, 2014
Actual Primary Completion Date : March 29, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Stretching (Control)
Six months of stretching
Behavioral: Stretching (control)
Stretch controls will be enrolled in supervised stretching program for 2 days/week for 1 hour sessions. The stretch program will focus on basic mobility skills, including balance, endurance, sit-to-stand, weight shifting, leg strength, and truncal stability-coordination. Stretching will be done in groups up to 6 participants. Exercises will be performed in standing, seated, and lying positions. A log book on the stretching exercise participation and progression will be maintained and reviewed by the instructor with the participant at each session.

Experimental: Treadmill Exercise
Six months of treadmill training
Behavioral: Treadmill Exercise
Training will be started conservatively with a goal of 15 minutes total duration at 40-50% HRR. Training target HR = %(HRmax - HRrest) + HRrest. HR max is defined as peak HR based on 2 maximal exercise tests at baseline. Individuals unable to walk continuously will exercise intermittently for several minutes as tolerated, with rest intervals, and advanced as tolerated with HR, blood pressure monitoring, and Borg Perceived Exertion to assess subjective cardiopulmonary exercise tolerance, as previously described. Treadmill training velocity will advance as tolerated by week 6 to a target intensity of 70-80% maximal HRR. Duration will similarly advance to a target of 30 minutes by week 6. Following week 6, the progressive training protocol will continue with attempts to increase velocity on a weekly basis and increase duration by 5 minutes bi-weekly to peak at 50 minutes. After week 6, the target HR goal will be 75-85% of HRR as tolerated by the subject.




Primary Outcome Measures :
  1. the change in total daily energy expenditure [ Time Frame: measured at baseline and following 6 months of treadmill training or stretching (control) ]
    Subjects will wear an accelerometer activity monitor on their belt for 5 to 7 days to determine caloric expenditure in daily activities.


Secondary Outcome Measures :
  1. the change in substrate oxidation [ Time Frame: measured at baseline, after 2 weeks of dietary education, and following 6 months of treadmill training or stretching (control) ]
    After a 12 hour fast, economy of hemiparetic gait will be measured using open circuit spirometry during a standard constant load submaximal effort treadmill walking task at a pre-established gait velocity (80% of self-selected floor walking velocity). This slower walking velocity is selected because untrained subjects with stroke usually cannot maintain their self-selected walking pace, precluding steady state measures of oxygen consumption that defines gait economy. The mean rate of VO2 will be calculated based on the final 3 minutes of a 10-minute walk under steady state oxygen consumption conditions, as previously described. Subjects not achieving a plateau in VO2 will be re-tested at a lower velocity on a different date to eliminate potential confounding effects of fatigue on testing.

  2. the change in tissue oxidative stress [ Time Frame: measured at baseline and following 6 months of treadmill training or stretching (control) ]
    Bilateral vastus lateralis muscle biopsies (500-800 mg) will be obtained with a Bergstrom needle with local anesthesia, 1% lidocaine. Muscle tissue will quantitate local oxidative stress markers.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043574


Locations
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United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Monica C Serra, PhD South Texas Health Care System, San Antonio, TX

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02043574     History of Changes
Other Study ID Numbers: N0944-W
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Aerobic Exercise
Treadmill Test
Sedentary Lifestyle

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases