Nutrition and Aerobic Exercise in Chronic Stroke

NCT02043574 | Completed Results DMC

• 1 other identifier: N0944-W
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

Aerobic Exercise; Treadmill Test; Sedentary Lifestyle

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• The Change in Substrate Oxidation

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

• The Change in Circulating Nitrotyrosine

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

Study Arms (2)

Stretching (Control)

OTHER

Six months of stretching

Behavioral: Stretching (control)

Treadmill Exercise

EXPERIMENTAL

Six months of treadmill training

Behavioral: Treadmill Exercise

Interventions

Treadmill Exercise BEHAVIORAL

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.

Treadmill Exercise

Stretching (control) BEHAVIORAL

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.

Stretching (Control)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

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

Baltimore, Maryland, 21201, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Serra MC, Hafer-Macko CE, Robbins R, O'Connor JC, Ryan AS. Randomization to Treadmill Training Improves Physical and Metabolic Health in Association With Declines in Oxidative Stress in Stroke. Arch Phys Med Rehabil. 2022 Nov;103(11):2077-2084. doi: 10.1016/j.apmr.2022.06.011. Epub 2022 Jul 12.

  PMID: 35839921 DERIVED

MeSH Terms

Conditions

Stroke; Sedentary Behavior

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Results Point of Contact

• Title: Monica Serra
• Organization: South Texas Veterans Health Care System

monica.serra@va.gov

210-617-5300

Study Officials

• Monica C Serra, PhD

  South Texas Health Care System, San Antonio, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Subjects are randomized to either stretching or treadmill training.

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 23, 2014
• Study Start: November 17, 2014
• Primary Completion: March 29, 2019
• Study Completion: September 30, 2019
• Last Updated: January 31, 2020
• Results First Posted: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)