NCT02043574: NEXIS

Nutrition and Aerobic Exercise in Chronic Stroke

Completed NA Results posted Last updated 31 January 2020

What this trial tests

NA trial testing Treadmill Exercise in Stroke in 51 participants. Completed in 30 September 2019.

Timeline

17 November 2014

Primary endpoint
29 March 2019

30 September 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	17 November 2014
Primary completion	29 March 2019
Estimated completion	30 September 2019
Sites	2 locations across United States

Drugs / interventions tested

• Treadmill Exercise
• Stretching (control)

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

20 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Change in Total Daily Energy Expenditure Primary · 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.

Group	Value	95% CI
Stretching (Control)	-0.52	± 40.89
Treadmill Exercise	32.86	± 54.60

The Change in Substrate Oxidation Secondary · measured at baseline 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 (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 sta

Group	Value	95% CI
Stretching (Control)	0.013	± 0.072
Treadmill Exercise	0.083	± 0.135

The Change in Circulating Nitrotyrosine Secondary · measured at baseline and following 6 months of treadmill training or stretching (control)

Plasma will be used to quantitate circulating nitrotyrosine concentrations

Group	Value	95% CI
Stretching (Control)	-24.8	± 21.7
Treadmill Exercise	-36.5	± 30.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months from baseline. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Stretching (Control)

Serious: 1/19 (5%)

Deaths: 0/19

Treadmill Exercise

Serious: 1/20 (5%)

Deaths: 0/20

Serious adverse events (1 terms)

Reaction	System	Stretching (Control)	Treadmill Exercise
Recurrent stroke	Vascular disorders	—	—

Most-reported serious reactions: Recurrent stroke.

Data from ClinicalTrials.gov NCT02043574 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treadmill training and body weight support for walking after stroke.
   Mehrholz J, Thomas S, Elsner B. · · 2017 · cited 147× · PMID 28815562 · DOI 10.1002/14651858.cd002840.pub4
2. Randomization to Treadmill Training Improves Physical and Metabolic Health in Association With Declines in Oxidative Stress in Stroke.
   Serra MC, Hafer-Macko CE, Robbins R, O'Connor JC, et al · · 2022 · cited 14× · PMID 35839921 · DOI 10.1016/j.apmr.2022.06.011