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
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: Treadmill Exercise Behavioral: Stretching (control)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects are randomized to either stretching or treadmill training.|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
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
|United States, Maryland|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Monica C Serra, PhD||South Texas Health Care System, San Antonio, TX|