StrokeNEXISNCT02043574
Nutrition and Aerobic Exercise in Chronic Stroke
A study testing Treadmill Exercise in people with Stroke, run by VA Office of Research and Development at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Treadmill Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Nov 2014to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
About this study
Official title: Aerobic Training to Improve Energy Utilization and Antioxidant Capacity in Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Treadmill Exercise, Stretching (control)
- Keywords
- Aerobic Exercise, Treadmill Test, Sedentary Lifestyle
- Medical subject headings
- Stroke, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill ExerciseBehavioural
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.
Stretching (control)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stretching (Control) | Other | Six months of stretching Receives: Behavioral: Stretching (control) |
| Treadmill Exercise | Experimental | Six months of treadmill training Receives: Behavioral: Treadmill Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured at baseline and following 6 months of treadmill training or stretching (control)
Secondary outcomes (2)
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.
Measured: measured at baseline and following 6 months of treadmill training or stretching (control)
The Change in Circulating Nitrotyrosine
Plasma will be used to quantitate circulating nitrotyrosine concentrations
Measured: measured at baseline and following 6 months of treadmill training or stretching (control)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start17 Nov 2014
- Primary completion29 Mar 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects are randomized to either stretching or treadmill training.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Monica C Serra, PhD, Principal investigator, South Texas Health Care System, San Antonio, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043574
- Sponsor's protocol ID
- N0944-W
- Acronym
- NEXIS
- Status last verified
- Jan 2020
- First submitted
- 6 Jan 2014
- Last updated
- 31 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35839921
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Training to Improve Energy Utilization and Antioxidant Capacity in Stroke
- ClinicalTrials.gov ID
- NCT02043574
- Acronym / sponsor ID
- NEXIS / N0944-W
- Conditions
- Stroke
- Keywords
- Aerobic Exercise, Treadmill Test, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Posted 31 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects are randomized to either stretching or treadmill training.
| Arm | Type | Receives |
|---|---|---|
| Stretching (Control) | Other | Behavioral: Stretching (control)Six months of stretching |
| Treadmill Exercise | Experimental | Behavioral: Treadmill ExerciseSix months of treadmill training |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill ExerciseTraining 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. | Behavioural | Treadmill Exercise |
| 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. | Behavioural | Stretching (Control) |
Primary outcome
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.
2 secondary outcomes
The Change in Substrate Oxidation
Time frame: measured at baseline and following 6 months of treadmill training or stretching (control)
The Change in Circulating Nitrotyrosine
Time frame: measured at baseline and following 6 months of treadmill training or stretching (control)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35839921Serra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica C Serra, PhD principal investigator
South Texas Health Care System, San Antonio, TX
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Exercise in people with Stroke, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change in Total Daily Energy Expenditure (time frame: measured at baseline and following 6 months of treadmill training or stretching (control)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.