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Nutrition and Aerobic Exercise in Chronic Stroke (NEXIS)

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Treadmill Exercise

Stretching (control)

About this trial

This is an interventional treatment trial for Stroke focused on measuring Aerobic Exercise, Treadmill Test, Sedentary Lifestyle

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
South Texas Health Care System, San Antonio, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Stretching (Control)

Treadmill Exercise

Arm Description

Six months of stretching

Six months of treadmill training

Outcomes

Primary Outcome Measures

The Change in Total Daily Energy Expenditure

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

The Change in Substrate Oxidation

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 (60% 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. We will calculate the change in respiratory exchange ratio from rest to the final 3 minutes of a 10-minute walk under steady state oxygen consumption conditions (RER at 60%VO2peak-RER at rest). 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.

The Change in Circulating Nitrotyrosine

Plasma will be used to quantitate circulating nitrotyrosine concentrations

Full Information

NCT ID

NCT02043574

First Posted

January 6, 2014

Last Updated

January 21, 2020

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT02043574

Brief Title

Nutrition and Aerobic Exercise in Chronic Stroke

Acronym

NEXIS

Official Title

Aerobic Training to Improve Energy Utilization and Antioxidant Capacity in Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

November 17, 2014 (Actual)

Primary Completion Date

March 29, 2019 (Actual)

Study Completion Date

September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Aerobic Exercise, Treadmill Test, Sedentary Lifestyle

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Subjects are randomized to either stretching or treadmill training.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stretching (Control)

Arm Type

Other

Arm Description

Six months of stretching

Arm Title

Treadmill Exercise

Arm Type

Experimental

Arm Description

Six months of treadmill training

Intervention Type

Behavioral

Intervention Name(s)

Treadmill Exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Stretching (control)

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Change in Total Daily Energy Expenditure

Description

Subjects will wear an accelerometer activity monitor on their belt for 5 to 7 days to determine caloric expenditure in daily activities.

Time Frame

measured at baseline and following 6 months of treadmill training or stretching (control)

Secondary Outcome Measure Information:

Title

The Change in Substrate Oxidation

Description

Time Frame

measured at baseline and following 6 months of treadmill training or stretching (control)

Title

The Change in Circulating Nitrotyrosine

Description

Plasma will be used to quantitate circulating nitrotyrosine concentrations

Time Frame

measured at baseline and following 6 months of treadmill training or stretching (control)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Monica C Serra, PhD

Organizational Affiliation

South Texas Health Care System, San Antonio, TX

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

South Texas Health Care System, San Antonio, TX

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Nutrition and Aerobic Exercise in Chronic Stroke

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