Parkinson's DiseaseGen-ExNCT03607695
Genetic Influences on Response to Gait Rehabilitation in Parkinson's Disease
A study testing Gait training in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The aging Veteran population, together with high exposure to Agent Orange or other herbicides during military service, has made diseases such as Parkinson's disease (PD), currently affecting more than 80,000 Veterans, a major health issue in the Veterans' health system. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 30 Jun 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet UK Brain Bank (UKBB) criteria for the diagnosis of PD (modified so that having more than one affected relative was not considered an exclusion criteria)
- Have a Hoehn \& Yahr score of 3
- Have the ability to walk 400 m without physical assistance from a device or another person
- Do not have other health conditions (e.g., orthopedic, cardiopulmonary) that impact the ability to safely participate in a moderately intense gait training program
Who cannot join
- The investigators will exclude those patients presenting clinical diagnosis of dementia.
- The investigators will exclude those patients presenting conditions (cardiac, renal, or metabolic) that would pose a risk to their health by exercising.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
The aging Veteran population, together with high exposure to Agent Orange or other herbicides during military service, has made diseases such as Parkinson's disease (PD), currently affecting more than 80,000 Veterans, a major health issue in the Veterans' health system. Mobility and cognitive limitations are a common problem in PD and are associated with significant disability, increased fall risk, reduced quality of life, and increased caregiver burden. While less is known about its benefit on cognition, physical therapy has proven to be an effective treatment to mitigate mobility limitations, though the response to rehabilitation interventions is highly variable. The proposed research will inform the investigators' understanding of the impact of certain genetic profiles associated with learning impairments on motor and cognitive benefits in response to gait rehabilitation, and will provide an important foundation for more personalized and improved gait rehabilitation programs for different subgroups of PD patients.
Read the detailed description
The completion of the Human Genome Project in 2003 marked the beginning of the genomic era and the birth of "personalized" (precision) medicine. In the last decade, genetics have provided a new understanding of predicting, diagnosing, and treating individual health conditions. Indeed, such precision medicine has begun to impact virtually all areas of medicine, with significant potential to influence the timing, dosage, and intensity of physical rehabilitation.
The long-term goals of this research are: (1) to determine if certain genetic variants associated to learning impairments impact the motor and cognitive benefit experienced in response to physical rehabilitation in Veterans with Parkinson's disease (PD), and (2) to use that knowledge to identify subpopulations of patients that may require rehabilitative strategies tailored to their genotype to optimize physical rehabilitation. To achieve these goals the investigators will enroll 30 Veterans with PD in a 10-week moderate intensity gait training program consisting of 2 times per week treadmill training with verbal cues for gait quality. Aim 1 will examine the association between variants in 2 genes known to affect cognition and motor learning (APOE- 4 and BDNF-Met66), and motor improvements after gait training. Specifically, changes in walking from during and after training will be sensitively and objectively assessed using state-of-the-art quantitative gait analysis, and compared between three genotype groups (carriers of BDNF-Met66 (N=10), carriers of APOE- 4 (N=10) and those not carrying either of those variants (N=10)). Aim 2 will examine the effect of APOE- 4 and BDNF-Met66 genetic variants on cognitive changes in response to this training program. In order to do this the investigators will measure cognitive performance pre- and post-training using a brief, targeted battery aimed at assessing attention, processing speed, executive function, and learning/memory, the domains more affected, and more likely to improve with physical exercise in PD. The investigators will test the hypothesis that Veterans with PD who carry an APOE- 4 or BDNF-Met66 allele will demonstrate smaller improvements in gait (Aim 1) and cognition (Aim 2) in response to a 10-week gait training program. Overall the results of this project will enhance the investigators' knowledge regarding the influence of different genetic profiles in the response to physical rehabilitation in Veterans with PD, and will generate supporting data that will translate to more personalized and effective rehabilitation programs for people with PD.
- Conditions
- Parkinson's Disease
- Being tested
- Gait training
- Keywords
- gait, exercise, cognition, genetics
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait trainingOther
Walking on a treadmill and receiving audio cues to improve gait
| Study group | Role | What they receive |
|---|---|---|
| Gait training | Experimental | 1 hour walking exercise on a treadmill Receives: Other: Gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed (m/s)
The investigators will use the APDM Movement Monitoring system to assess gait speed (m/s) during straight-line walking as a measure of gait function.
Measured: measured at baseline, 2 weeks, 10 weeks and 16 weeks
Montreal Cognitive Assessment Score
The investigators will use the Montreal Cognitive Assessment (MoCA; score range=0-30, with 30 indicating better cognitive function) as a reflection of global cognitive function
Measured: measured at baseline and at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Feb 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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.
- Other trials for Parkinson's DiseaseStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention is a 10-week gait, treadmill-training program. The sessions are 1 hour long, twice a week.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Ignacio Fernandez-Mata, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607695
- Sponsor's protocol ID
- E2553-P
- Other IDs
- I21RX002553-01
- Acronym
- Gen-Ex
- Status last verified
- Sep 2021
- First submitted
- 24 Jul 2018
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Influences on Response to Gait Rehabilitation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03607695
- Acronym / sponsor ID
- Gen-Ex / E2553-P
- Conditions
- Parkinson's Disease
- Keywords
- gait, exercise, cognition, genetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Washington
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Posted 27 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aging Veteran population, together with high exposure to Agent Orange or other herbicides during military service, has made diseases such as Parkinson's disease (PD), currently affecting more than 80,000 Veterans, a major health issue in the Veterans' health system. Mobility and cognitive limitations are a common problem in PD and are associated with significant disability, increased fall risk, reduced quality of life, and increased caregiver burden. While less is known about its benefit on cognition, physical therapy has proven to be an effective treatment to mitigate mobility limitations, though the response to rehabilitation interventions is highly variable. The proposed research will inform the investigators' understanding of the impact of certain genetic profiles associated with learning impairments on motor and cognitive benefits in response to gait rehabilitation, and will provide an important foundation for more personalized and improved gait rehabilitation programs for different subgroups of PD patients.
Detailed description
The completion of the Human Genome Project in 2003 marked the beginning of the genomic era and the birth of "personalized" (precision) medicine. In the last decade, genetics have provided a new understanding of predicting, diagnosing, and treating individual health conditions. Indeed, such precision medicine has begun to impact virtually all areas of medicine, with significant potential to influence the timing, dosage, and intensity of physical rehabilitation.
The long-term goals of this research are: (1) to determine if certain genetic variants associated to learning impairments impact the motor and cognitive benefit experienced in response to physical rehabilitation in Veterans with Parkinson's disease (PD), and (2) to use that knowledge to identify subpopulations of patients that may require rehabilitative strategies tailored to their genotype to optimize physical rehabilitation. To achieve these goals the investigators will enroll 30 Veterans with PD in a 10-week moderate intensity gait training program consisting of 2 times per week treadmill training with verbal cues for gait quality. Aim 1 will examine the association between variants in 2 genes known to affect cognition and motor learning (APOE- 4 and BDNF-Met66), and motor improvements after gait training. Specifically, changes in walking from during and after training will be sensitively and objectively assessed using state-of-the-art quantitative gait analysis, and compared between three genotype groups (carriers of BDNF-Met66 (N=10), carriers of APOE- 4 (N=10) and those not carrying either of those variants (N=10)). Aim 2 will examine the effect of APOE- 4 and BDNF-Met66 genetic variants on cognitive changes in response to this training program. In order to do this the investigators will measure cognitive performance pre- and post-training using a brief, targeted battery aimed at assessing attention, processing speed, executive function, and learning/memory, the domains more affected, and more likely to improve with physical exercise in PD. The investigators will test the hypothesis that Veterans with PD who carry an APOE- 4 or BDNF-Met66 allele will demonstrate smaller improvements in gait (Aim 1) and cognition (Aim 2) in response to a 10-week gait training program. Overall the results of this project will enhance the investigators' knowledge regarding the influence of different genetic profiles in the response to physical rehabilitation in Veterans with PD, and will generate supporting data that will translate to more personalized and effective rehabilitation programs for people with PD.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention is a 10-week gait, treadmill-training program. The sessions are 1 hour long, twice a week.
| Arm | Type | Receives |
|---|---|---|
| Gait training | Experimental | Other: Gait training1 hour walking exercise on a treadmill |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet UK Brain Bank (UKBB) criteria for the diagnosis of PD (modified so that having more than one affected relative was not considered an exclusion criteria)
- Have a Hoehn \& Yahr score of 3
- Have the ability to walk 400 m without physical assistance from a device or another person
- Do not have other health conditions (e.g., orthopedic, cardiopulmonary) that impact the ability to safely participate in a moderately intense gait training program
Key exclusion criteria (2 listed)
- The investigators will exclude those patients presenting clinical diagnosis of dementia.
- The investigators will exclude those patients presenting conditions (cardiac, renal, or metabolic) that would pose a risk to their health by exercising.
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 |
|---|---|---|
| Gait trainingWalking on a treadmill and receiving audio cues to improve gait | Other | Gait training |
Primary outcome
Gait Speed (m/s)
Time frame: measured at baseline, 2 weeks, 10 weeks and 16 weeks
The investigators will use the APDM Movement Monitoring system to assess gait speed (m/s) during straight-line walking as a measure of gait function.
Montreal Cognitive Assessment Score
Time frame: measured at baseline and at 10 weeks
The investigators will use the Montreal Cognitive Assessment (MoCA; score range=0-30, with 30 indicating better cognitive function) as a reflection of global cognitive function
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We will not make individual participant data available.
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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.
Ignacio Fernandez-Mata principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training in people with Parkinson's Disease, run by VA Office of Research and Development 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 4 inclusion and 2 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 27 Oct 2021. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2021). 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?
Gait Speed (m/s) (time frame: measured at baseline, 2 weeks, 10 weeks and 16 weeks). The study lists 2 primary outcomes in all. 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 27 Oct 2021.