Parkinson's DiseaseEEforPDNCT02231073
Exercise, Brain Imaging, Cognition, and Gait in Parkinsonism
A study testing Exercise and Education for Parkinson's Disease in people with Parkinson's Disease, run by Oregon Health and Science University at 1 site in United States.
Trial summary
There is emerging research detailing the relationship between balance/gait/falls and cognition. Imaging studies also suggest a link between structural and functional changes in the frontal lobe (a region commonly associated with cognitive function) and mobility. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Exercise and Education for Parkinson's Disease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2018
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50-90 years old. No musculoskeletal or peripheral or central nervous system disorders (other than idiopathic Parkinson disease (iPD) or parkinsonism) that could significantly affect balance or gait .
- Capable of following directions. iPD subjects: UK Brain Bank criteria, i.e., bradykinesia and at least one of the following: rest tremor, muscular rigidity, and postural instability not cause by visual, vestibular, cerebellar or proprioceptive dysfunction. Unilateral onset, response to levodopa.
- Parkinsonism subjects: Gait characterized by slow short steps, shuffling gait and may be wide-based, with FoG, postural instability.
Who cannot join
- Inability to stand or walk for 2 min without an assistive device Recent changes in medication Excessive use of alcohol or recreational drugs, Contraindications to MRI scans (eg, claustrophobia, metal in body) Intervention subjects will be excluded if: 1) participating in a vigorous exercise program more than 2 x/week, 2) A medical condition that contraindicates exercise participation.
- Parkinsonism subjects: iPD and Parkinson plus syndromes such as Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Syndrome, or Cerebellar Ataxia.
- Idiopathic PD subjects: Same as above and deep brain stimulation electrodes. Significant tremor that would interfere withMRI scan.
- Control subjects: Will be matched for age and gender to iPD and parkinsonism groups.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Peripheral and Central Postural Disorders in the Elderly
There is emerging research detailing the relationship between balance/gait/falls and cognition. Imaging studies also suggest a link between structural and functional changes in the frontal lobe (a region commonly associated with cognitive function) and mobility. People with Parkinson's disease have important changes in cognitive function that may impact rehabilitation efficacy. Our underlying hypothesis is that cognitive function and frontal lobe connections with the basal ganglia and brainstem posture/locomotor centers are responsible for postural deficits in people with Parkinson's disease and play a role in rehabilitation efficacy. The purpose of this study is to 1) determine if people with Parkinson's disease can improve mobility and/or cognition after partaking in a cognitively challenging mobility exercise program and 2) determine if cognition and brain circuitry deficits predict responsiveness to exercise rehabilitation.
Design: This study is a randomized cross-over controlled intervention to take place at a University Balance Disorders Laboratory. The study participants will be people with Parkinson's disease who meet inclusion criteria for the study. The intervention will be 6 weeks of group exercise (case) and 6 weeks of group education (control). The exercise is a cognitively challenging program based on the Agility Boot Camp for people with PD. The education program is a 6-week program to teach people how to better live with a chronic disease. The primary outcome measure is the MiniBESTest and the secondary outcomes are measures of mobility, cognition and neural imaging.
Discussion: The results from this study will further our understanding of the relationship between cognition and mobility with a focus on brain circuitry as it relates to rehabilitation potential.
- Conditions
- Parkinson's Disease
- Being tested
- Exercise and Education for Parkinson's Disease
- Keywords
- Freezing of gait, Idiopathic Parkinson's disease, Exercise, parkinsonism
- Medical subject headings
- Parkinson Disease, Motor Activity, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and Education for Parkinson's DiseaseBehavioural
Exercise and Education for Parkinson's Disease for 6 week cross-over intervention.
| Study group | Role | What they receive |
|---|---|---|
| Exercise: Agility Boot Camp-Cognitive | Experimental | Subjects will participate in an 80-minute, group (6 per group) exercise session led by a certified exercise trainer knowledgeable in the Agility Boot Camp-Cognitive (ABC-C) program for 3x/week for 6 weeks. The exercise protocol is an adaptation of our Agility Boot Camp (ABC) exercise program for PD. The exercises are designed as a circuit to challenge movement-skills known to be impaired in PD. Stations will include: Gait training, PWR Moves ©, Agility course, Lunges, Boxing and Tai Chi. Each activity was chosen for its inherent focus on multi-directional movements, dynamic postural transitions, axial mobility, big movements and whole body motor sequencing. Each station (10-20 minutes) has 3 possible progression levels, based on: (1) divided attention with secondary cognitive tasks, (2) response inhibition, (3) limiting external sensory cues, and (4) increasing speed and resistance. Receives: Behavioral: Exercise and Education for Parkinson's Disease |
| Education: Living with Parkinson's disease | Active comparator | The Education arm is a chronic disease education program to teach patients how to live better with their chronic condition. It was developed by our research team to be specific for people with Parkinson's disease. It will include content and discussion of topics such as sleep, nutrition, and medication management. Classes will consist of a group of subjects (up to 6) meeting with the trainer for 90-minute session, once a week for six weeks. In order to match dose of the education intervention with the exercise intervention, participants will be provided relaxation tapes to be used at home 5 times per week for 30 minutes for an overall education dose of 240 minutes; similar to the exercise dose. Receives: Behavioral: Exercise and Education for Parkinson's Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mini-BESTest score
The Mini-BESTest assesses dynamic balance via a 14-item test that measures multiple domains of balance including anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait.
Measured: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary outcomes (7)
Change in MDS-UPDRS score
The Unified Parkinson's Disease Rating Scale Motor Subscale III is a 10-minute assessment of motor signs related to severity of PD. If the investigators have trouble recruiting subjects of similar severity in the 2 groups, they will use the Postural Instability and Gait Disability(PIGD) Subscore (Items 27-30) as a covariate in data analysis.
Measured: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in New Freezing of Gait questionnaire (NFOGQ) score
The New FoG of Gait Questionnaire will be used to identify 'freezers' (score >3). NFOGQ is a self-report measure that begins with the presentation of a short (30-s) video to illustrate FoG during walking turning and starting gait and then follows with questions related to frequency and duration of each type of FoG episode.
Measured: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in PDQ-39 score
the Parkinson's Disease Quality of Life questionnaire with 39 questions reflecting 8 domains of quality of life (Mobility, ADL's, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort). Each item scores from 0 (never) to 4 (always). Subscale scores and a summary index representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life. Convergent validity is very good and discriminative validity for PD severity levels has been established. The PDQ will reflect limitations to participation in community mobility.
Measured: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in Activities of Balance Confidence (ABC) questionnaire score
Activities of Balance Confidence (ABC) questionnaire consists of 16 questions about how balance confidence limits participating in the community such as riding an escalator, walking in a parking lot and replacing a light. Subjects indicate their confidence from 0% to 100% they have in their balance when they imagine doing these tasks. A score of 80% indicates an average level of physical functioning for older adults.
Measured: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in instrumented gait and balance measures
Balance: Postural sway during quiet stance with and without a cognitive task. Gait: Spatial and temporal gait metrics will be collected during walking, while wearing the Opal inertial sensors, with and without a cognitive task.
Turning: Smoothness of turning measure during 1 min turning in place (360 degree) and turns during 2 min walk, with and without a cognitive task.
Measured: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Neural Imaging
DTI: High angular resolution diffusion imaging to assess white matter microstructure. Structural connectivity of the locomotor network will be assessed using probabilistic tractography.
rsfcMRI: An indirect assessment of communication between spatially disparate neural regions. Analysis is restricted to neural regions comprising the locomotor network including the supplementary motor area, subthalamic nuclei, mesencephalic locomotor regions (pedunculopontine and cuneiform nuclei), and the midline cerebellar locomotor region
Measured: Baseline
Change in Cognitive measures
A battery of tests to measure different cognitive domains: inhibition (stroop, flankers, go/nogo, stop signal), shifting (set-shifting, trail making), updating (dot counting task), visual-spatial (judgement of line orientation), general cognition (SCOPA-COG), and other (social norms questionnaire, social behavior rating scale, simple reaction time test).
Measured: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Fay B. Horak, Oregon Health and Science University
- Investigators
- Fay B Horak, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231073
- Sponsor's protocol ID
- 4131
- Other IDs
- 2R01AG006457
- Acronym
- EEforPD
- Status last verified
- Jul 2019
- First submitted
- 18 Aug 2014
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886King LA, Peterson DS, Mancini M, Carlson-Kuhta P, Fling BW, Smulders K, Nutt JG, Dale M, Carter J, Winters-Stone KM, Horak FB. Do cognitive measures and brain circuitry predict outcomes of exercise in Parkinson Disease: a randomized clinical trial. BMC Neurol. 2015 Oct 24;15:218. doi: 10.1186/s12883-015-0474-2.
PubMed 26499867
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral and Central Postural Disorders in the Elderly
- ClinicalTrials.gov ID
- NCT02231073
- Acronym / sponsor ID
- EEforPD / 4131
- Conditions
- Parkinson's Disease
- Keywords
- Freezing of gait, Idiopathic Parkinson's disease, Exercise, parkinsonism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 4 Sep 2014 (estimated)
- 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.
There is emerging research detailing the relationship between balance/gait/falls and cognition. Imaging studies also suggest a link between structural and functional changes in the frontal lobe (a region commonly associated with cognitive function) and mobility. People with Parkinson's disease have important changes in cognitive function that may impact rehabilitation efficacy. Our underlying hypothesis is that cognitive function and frontal lobe connections with the basal ganglia and brainstem posture/locomotor centers are responsible for postural deficits in people with Parkinson's disease and play a role in rehabilitation efficacy. The purpose of this study is to 1) determine if people with Parkinson's disease can improve mobility and/or cognition after partaking in a cognitively challenging mobility exercise program and 2) determine if cognition and brain circuitry deficits predict responsiveness to exercise rehabilitation.
Design: This study is a randomized cross-over controlled intervention to take place at a University Balance Disorders Laboratory. The study participants will be people with Parkinson's disease who meet inclusion criteria for the study. The intervention will be 6 weeks of group exercise (case) and 6 weeks of group education (control). The exercise is a cognitively challenging program based on the Agility Boot Camp for people with PD. The education program is a 6-week program to teach people how to better live with a chronic disease. The primary outcome measure is the MiniBESTest and the secondary outcomes are measures of mobility, cognition and neural imaging.
Discussion: The results from this study will further our understanding of the relationship between cognition and mobility with a focus on brain circuitry as it relates to rehabilitation potential.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise: Agility Boot Camp-Cognitive | Experimental | Behavioral: Exercise and Education for Parkinson's DiseaseSubjects will participate in an 80-minute, group (6 per group) exercise session led by a certified exercise trainer knowledgeable in the Agility Boot Camp-Cognitive (ABC-C) program for 3x/week for 6 weeks. The exercise protocol is an adaptation of our Agility Boot Camp (ABC) exercise program for PD. The exercises are designed as a circuit to challenge movement-skills known to be impaired in PD. Stations will include: Gait training, PWR Moves ©, Agility course, Lunges, Boxing and Tai Chi. Each activity was chosen for its inherent focus on multi-directional movements, dynamic postural transitions, axial mobility, big movements and whole body motor sequencing. Each station (10-20 minutes) has 3 possible progression levels, based on: (1) divided attention with secondary cognitive tasks, (2) response inhibition, (3) limiting external sensory cues, and (4) increasing speed and resistance. |
| Education: Living with Parkinson's disease | Active comparator | Behavioral: Exercise and Education for Parkinson's DiseaseThe Education arm is a chronic disease education program to teach patients how to live better with their chronic condition. It was developed by our research team to be specific for people with Parkinson's disease. It will include content and discussion of topics such as sleep, nutrition, and medication management. Classes will consist of a group of subjects (up to 6) meeting with the trainer for 90-minute session, once a week for six weeks. In order to match dose of the education intervention with the exercise intervention, participants will be provided relaxation tapes to be used at home 5 times per week for 30 minutes for an overall education dose of 240 minutes; similar to the exercise dose. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 50-90 years old. No musculoskeletal or peripheral or central nervous system disorders (other than idiopathic Parkinson disease (iPD) or parkinsonism) that could significantly affect balance or gait .
- Capable of following directions. iPD subjects: UK Brain Bank criteria, i.e., bradykinesia and at least one of the following: rest tremor, muscular rigidity, and postural instability not cause by visual, vestibular, cerebellar or proprioceptive dysfunction. Unilateral onset, response to levodopa.
- Parkinsonism subjects: Gait characterized by slow short steps, shuffling gait and may be wide-based, with FoG, postural instability.
Key exclusion criteria (5 listed)
- Inability to stand or walk for 2 min without an assistive device Recent changes in medication Excessive use of alcohol or recreational drugs, Contraindications to MRI scans (eg, claustrophobia, metal in body) Intervention subjects will be excluded if: 1) participating in a vigorous exercise program more than 2 x/week, 2) A medical condition that contraindicates exercise participation.
- Parkinsonism subjects: iPD and Parkinson plus syndromes such as Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Syndrome, or Cerebellar Ataxia.
- Idiopathic PD subjects: Same as above and deep brain stimulation electrodes. Significant tremor that would interfere withMRI scan.
- Control subjects: Will be matched for age and gender to iPD and parkinsonism groups.
- -
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 |
|---|---|---|
| Exercise and Education for Parkinson's DiseaseExercise and Education for Parkinson's Disease for 6 week cross-over intervention. | Behavioural | Education: Living with Parkinson's disease, Exercise: Agility Boot Camp-Cognitive |
Primary outcome
Change in Mini-BESTest score
Time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
The Mini-BESTest assesses dynamic balance via a 14-item test that measures multiple domains of balance including anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait.
7 secondary outcomes
Change in MDS-UPDRS score
Time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in New Freezing of Gait questionnaire (NFOGQ) score
Time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in PDQ-39 score
Time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in Activities of Balance Confidence (ABC) questionnaire score
Time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in instrumented gait and balance measures
Time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Neural Imaging
Time frame: Baseline
Change in Cognitive measures
Time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- Derived from this study: PubMed 26499867King LA, Peterson DS, Mancini M, Carlson-Kuhta P, Fling BW, Smulders K, Nutt JG, Dale M, Carter J, Winters-Stone KM, Horak FB. Do cognitive measures and brain circuitry predict outcomes of exercise in Parkinson Disease: a randomized clinical trial. BMC Neurol. 2015 Oct 24;15:218. doi: 10.1186/s12883-015-0474-2.
- 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.
Fay B Horak, PhD principal investigator
Oregon Health and Science 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 Exercise and Education for Parkinson's Disease in people with Parkinson's Disease, run by Oregon Health and Science University 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: finished, as of the sponsor's last update on 25 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Mini-BESTest score (time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)). 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 NCT02231073, which also lists 3 linked publications.
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 25 Jul 2019.