StrokeNCT03701815
Effect of Lifestyle Changes on BDNF Level After Stroke
A study testing Wellness in Rehabilitation program in people with Stroke, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
This is a pilot study to determine whether a lifestyle medicine intervention following stroke may increase levels of Brain-Derived Neurotrophic Factor (BDNF). Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Wellness in Rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of prior stroke (ischemic or hemorrhagic) or transient ischemic attack
- Ability to ambulate at least 10 feet with minimal to moderate assistance
- Ability to travel to intervention site on a weekly basis.
Who cannot join
- Cerebral aneurysm
- Concurrent pregnancy
- Serious terminal illnesses (e.g. end stage renal disease, heart failure (class IV), cirrhosis (class C), metastatic cancer)
- Any injury or illness preventing participation in regular aerobic exercise
- Moderate-severe dementia or cognitive decline
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Palo Alto Health Care System
Palo Alto, California, 94304
Jeffrey Krauss, MD, 650-493-5000 ext. 65525, jeffrey.krauss@va.gov
About this study
Official title: Assessing the Effect of Multi-disciplinary Lifestyle Medicine Intervention on Brain-derived Neurotrophic Factor Levels Following Stroke
This is a pilot study to determine whether a lifestyle medicine intervention following stroke may increase levels of Brain-Derived Neurotrophic Factor (BDNF).
Read the detailed description
This is a substudy of the study entitled "Assessing a Multi-Disciplinary Lifestyle Medicine Intervention Following Stroke," specifically looking at the effects of lifestyle change on brain-derived neurotrophic factor (BDNF). BDNF has emerged as a key facilitator of neuroplasticity to improve motor learning and rehabilitation after stroke. Aerobic exercise has been shown to increase levels of BDNF in multiple parts of the central nervous system and therefore may facilitate neuroplasticity and motor recovery. While BDNF levels appear to be increased for up to 1 hour following a bout of aerobic exercise, it is unclear whether regular aerobic exercise over weeks to months can increase baseline BDNF levels in humans following stroke.
An single nucleotide polymorphism exists on the BDNF gene in 30-50% of the human population that results in an amino acid change from valine (val) to methionine (met) at position 66 (val66met) of the precursor peptide proBDNF. The presence of the met allele results in a 25% reduction in activity-dependent secretion of BDNF in the CNS.
The Wellness in Rehabilitation program at the VA Palo Alto Health Care System is a lifestyle medicine intervention for patients following stroke. It is a 12-week program involving weekly meetings that include exercise (particularly aerobic exercise), nutrition, stress management, education, and group support. Participants are encouraged to perform healthy lifestyle behaviors (i.e. exercise) daily at home, and a health coach calls each patient weekly to support the behavior change process.
Participants in the Wellness in Rehabilitation program who elect to participate in the research study will have blood drawn at baseline, week 6, and week 12. Blood draws will be performed in the morning prior to exercise, and week 6 will additionally include a blood draw within 30 minutes of completing a bout of aerobic exercise. Following completion of the study, plasma BDNF levels (measured as nanograms per milliliter) will then be measured at all 4 time points (baseline, week 6 pre-exercise, week 6 post-exercise, and week 12). In addition, BDNF genotype will be measured using the baseline sample. Participants will also complete bike or treadmill exercise testing at baseline and week 12 to determine pre- and post-program cardiovascular fitness levels (measured as VO2 max and estimated metabolic equivalents), and will also complete a 6-minute walk test. They will be asked to record their exercise daily and will additionally complete the Physical Activity Scale for Individuals with Physical Disabilities at baseline and week 12 time points.
- Conditions
- Stroke
- Being tested
- Wellness in Rehabilitation program
- Keywords
- brain-derived neurotrophic factor, exercise, BDNF, lifestyle medicine
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness in Rehabilitation programBehavioural
Also called Lifestyle Medicine program
The 12-week Wellness in Rehabilitation program includes weekly in-person meetings including aerobic exercise, nutrition/cooking training, stress management techniques, education, and group support. A health coach will facilitate continuation of healthy behaviors at home.
| Study group | Role | What they receive |
|---|---|---|
| Post-stroke | Experimental | Patients will receive a 12-week lifestyle medicine program. Receives: Behavioral: Wellness in Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF level - Final
Plasma BDNF protein levels, expressed in nanograms per milliliter, measured prior to any exercise upon completion of intervention.
Measured: Week 12
Secondary outcomes (5)
BDNF level - Post-exercise
Plasma BDNF protein levels, expressed in nanograms per milliliter, measured immediately following bout of aerobic exercise.
Measured: Week 6
BDNF Genotype
Genotyping of venous blood samples to determine ValVal, MetMet, and ValMet distribution.
Measured: Baseline
Cardiovascular Fitness - VO2 max
Measured as VO2 max (ml/kg/min).
Measured: Week 12
Cardiovascular Fitness - METs
Measured as estimated metabolic equivalents (kcal/kg/hour).
Measured: Week 12
6-minute Walk Test
Total distance walked 6 minutes on a flat surface.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start19 Jan 2018
- Primary completion11 Jan 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Stanford University, Spaulding Rehabilitation Hospital
- Responsible party
- Principal investigator, Jeffrey Krauss, VA Palo Alto Health Care System
- Investigators
- Jeffrey Krauss, MD, Principal investigator, VA Palo Alto Health Care System, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701815
- Sponsor's protocol ID
- KRU001
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Multi-disciplinary Lifestyle Medicine Intervention on Brain-derived Neurotrophic Factor Levels Following Stroke
- ClinicalTrials.gov ID
- NCT03701815
- Acronym / sponsor ID
- KRU001
- Conditions
- Stroke
- Keywords
- brain-derived neurotrophic factor, exercise, BDNF, lifestyle medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Collaborators
- Stanford University, Spaulding Rehabilitation Hospital
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 11 Jan 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 10 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to determine whether a lifestyle medicine intervention following stroke may increase levels of Brain-Derived Neurotrophic Factor (BDNF).
Detailed description
This is a substudy of the study entitled "Assessing a Multi-Disciplinary Lifestyle Medicine Intervention Following Stroke," specifically looking at the effects of lifestyle change on brain-derived neurotrophic factor (BDNF). BDNF has emerged as a key facilitator of neuroplasticity to improve motor learning and rehabilitation after stroke. Aerobic exercise has been shown to increase levels of BDNF in multiple parts of the central nervous system and therefore may facilitate neuroplasticity and motor recovery. While BDNF levels appear to be increased for up to 1 hour following a bout of aerobic exercise, it is unclear whether regular aerobic exercise over weeks to months can increase baseline BDNF levels in humans following stroke.
An single nucleotide polymorphism exists on the BDNF gene in 30-50% of the human population that results in an amino acid change from valine (val) to methionine (met) at position 66 (val66met) of the precursor peptide proBDNF. The presence of the met allele results in a 25% reduction in activity-dependent secretion of BDNF in the CNS.
The Wellness in Rehabilitation program at the VA Palo Alto Health Care System is a lifestyle medicine intervention for patients following stroke. It is a 12-week program involving weekly meetings that include exercise (particularly aerobic exercise), nutrition, stress management, education, and group support. Participants are encouraged to perform healthy lifestyle behaviors (i.e. exercise) daily at home, and a health coach calls each patient weekly to support the behavior change process.
Participants in the Wellness in Rehabilitation program who elect to participate in the research study will have blood drawn at baseline, week 6, and week 12. Blood draws will be performed in the morning prior to exercise, and week 6 will additionally include a blood draw within 30 minutes of completing a bout of aerobic exercise. Following completion of the study, plasma BDNF levels (measured as nanograms per milliliter) will then be measured at all 4 time points (baseline, week 6 pre-exercise, week 6 post-exercise, and week 12). In addition, BDNF genotype will be measured using the baseline sample. Participants will also complete bike or treadmill exercise testing at baseline and week 12 to determine pre- and post-program cardiovascular fitness levels (measured as VO2 max and estimated metabolic equivalents), and will also complete a 6-minute walk test. They will be asked to record their exercise daily and will additionally complete the Physical Activity Scale for Individuals with Physical Disabilities at baseline and week 12 time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-stroke | Experimental | Behavioral: Wellness in Rehabilitation programPatients will receive a 12-week lifestyle medicine program. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of prior stroke (ischemic or hemorrhagic) or transient ischemic attack
- Ability to ambulate at least 10 feet with minimal to moderate assistance
- Ability to travel to intervention site on a weekly basis.
Key exclusion criteria (5 listed)
- Cerebral aneurysm
- Concurrent pregnancy
- Serious terminal illnesses (e.g. end stage renal disease, heart failure (class IV), cirrhosis (class C), metastatic cancer)
- Any injury or illness preventing participation in regular aerobic exercise
- Moderate-severe dementia or cognitive decline
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 |
|---|---|---|
| Wellness in Rehabilitation programAlso: Lifestyle Medicine programThe 12-week Wellness in Rehabilitation program includes weekly in-person meetings including aerobic exercise, nutrition/cooking training, stress management techniques, education, and group support. A health coach will facilitate continuation of healthy behaviors at home. | Behavioural | Post-stroke |
Primary outcome
BDNF level - Final
Time frame: Week 12
Plasma BDNF protein levels, expressed in nanograms per milliliter, measured prior to any exercise upon completion of intervention.
5 secondary outcomes
BDNF level - Post-exercise
Time frame: Week 6
BDNF Genotype
Time frame: Baseline
Cardiovascular Fitness - VO2 max
Time frame: Week 12
Cardiovascular Fitness - METs
Time frame: Week 12
6-minute Walk Test
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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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.
Jeffrey Krauss, MD principal investigator
VA Palo Alto Health Care System, Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness in Rehabilitation program in people with Stroke, run by VA Palo Alto Health Care System at 1 site 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Krauss, MD (6504935000 ext. 65525, jkrauss@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF level - Final (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2018; AzTrials last refreshed its copy on 5 Nov 2026.