- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02268617
Treadmill Walking in Individuals With Dementia With Lewy Bodies and Huntington's Disease
Immediate Effects of Treadmill Walking in Individuals With Dementia With Lewy Bodies and Huntington's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Several studies using HD animal models have shown that HD mice housed in enriched environments or in cages with running wheels that stimulated physical activity demonstrated a delayed onset and/or slowed decline in motor function compared to mice in non-enriched environments (van Dellen et al. 2000, 2008; Spires et al., 2004). Evidence suggests that aerobic exercise may have neuroprotective effects and helps the elderly and individuals with neurodegenerative diseases to maintain better cognitive and motor function than those who are inactive. More specifically, there is strong evidence from animal and human trials in neurological populations (i.e., Parkinson's Disease, spinal cord injury, and stroke) that treadmill training can improve walking and motor function. Immediate effects of a single-session of treadmill walking in the Parkinson's Disease population were improved over-ground gait measures (i.e., gait speed, stride length, double support percent, stride variability) and longer term treadmill training studies demonstrated additional improvements in Unified Parkinson Disease Rating Scale scores, fall risk, and health-related quality of life (Herman et al., 2008). This study builds upon foundational knowledge gained in animals and other neurologic populations to determine the feasibility, safety and possible immediate benefit of treadmill walking in individuals with HD.
The primary purpose of this pilot study is to investigate the the safety, feasibility and utility of a single 20-minute session of treadmill walking to improve gait parameters in ambulatory individuals with DLB and HD. Secondarily we will explore the effects of treadmill walking on mobility, fall risk, and motor coordination. Based on previous studies utilizing a single-session of treadmill training in the PD population, we hypothesize that treadmill walking will improve overground spatiotemporal gait parameters (gait speed, stride length, double support percent, and stride-to-stride variations in gait) in individuals with DLB and HD (Pohl et al., 2003; Frenkel-Toledo et al., 2005; Bello et al., 2008).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Physical Therapy Division
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of Huntington's disease or Dementia with Lewy Bodies,
- the ability to ambulate 80 feet without assistance, and
- the ability to provide informed consent and understand directions.
Exclusion Criteria:
- presence of any clinically significant musculoskeletal or neurological disease that would affect gait.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treadmill Walking
All subjects will walk on treadmill for a total of 20 minutes.
|
Following instructions and familiarization with the treadmill, participants will walk on the treadmill for 20 minutes total with rest periods as needed.
Treadmill speed will be set at each participant's overground comfortable walking speed for the first 5 minutes, provided that they can walk safely.
If necessary the speed will be lowered until a safe gait is achieved.
After 5 minutes the speed will be incrementally increased by10% each 5 minutes (3 times) as long as a safe gait (i.e., no abnormal vital signs, excessive effort, or loss of balance occurrences) can be maintained.
If the gait pattern becomes unsafe or more abnormal the speed will revert to the previous safe speed and be maintained at this level until the end of training session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vital signs
Time Frame: Within 24 hours
|
Blood pressure, heart rate, and rating of perceived exertion will be measured before, during, and after treadmill walking.
|
Within 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spatiotemporal gait measures
Time Frame: within 24 hours
|
Spatiotemporal gait parameters will be measured using a computerized system, a 4.88 meter electronic carpet equipped with sensors that record footfalls and communicate the information to a computer software program.
|
within 24 hours
|
Timed Up and Go Test
Time Frame: Within 24 hours
|
Mobility and fall risk will be measured using the Timed Up and Go Test (TUG) that includes standing up from a chair, walking 3 meters, turning and returning to sitting in the chair.
|
Within 24 hours
|
Q-motor testing
Time Frame: Within 24 hours
|
Motor coordination will be measured using force-transducer based measurement of grip forces during grasping and holding an object and of tapping forces and tap interval variability during fast repetitive finger and foot tapping.
|
Within 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Kloos, PhD, Ohio State University
Publications and helpful links
General Publications
- Bello O, Sanchez JA, Fernandez-del-Olmo M. Treadmill walking in Parkinson's disease patients: adaptation and generalization effect. Mov Disord. 2008 Jul 15;23(9):1243-9. doi: 10.1002/mds.22069.
- Bechtel N, Scahill RI, Rosas HD, Acharya T, van den Bogaard SJ, Jauffret C, Say MJ, Sturrock A, Johnson H, Onorato CE, Salat DH, Durr A, Leavitt BR, Roos RA, Landwehrmeyer GB, Langbehn DR, Stout JC, Tabrizi SJ, Reilmann R. Tapping linked to function and structure in premanifest and symptomatic Huntington disease. Neurology. 2010 Dec 14;75(24):2150-60. doi: 10.1212/WNL.0b013e3182020123. Epub 2010 Nov 10.
- Bilney B, Morris ME, Churchyard A, Chiu E, Georgiou-Karistianis N. Evidence for a disorder of locomotor timing in Huntington's disease. Mov Disord. 2005 Jan;20(1):51-7. doi: 10.1002/mds.20294.
- Churchyard AJ, Morris ME, Georgiou N, Chiu E, Cooper R, Iansek R. Gait dysfunction in Huntington's disease: parkinsonism and a disorder of timing. Implications for movement rehabilitation. Adv Neurol. 2001;87:375-85. No abstract available.
- Frenkel-Toledo S, Giladi N, Peretz C, Herman T, Gruendlinger L, Hausdorff JM. Treadmill walking as an external pacemaker to improve gait rhythm and stability in Parkinson's disease. Mov Disord. 2005 Sep;20(9):1109-14. doi: 10.1002/mds.20507.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Cognition Disorders
- Chorea
- Dementia
- Lewy Body Disease
- Huntington Disease
Other Study ID Numbers
- 2012H0385
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lewy Body Disease
-
University of FloridaNational Institute on Aging (NIA)RecruitingLewy Body Dementia With Behavioral Disturbance | Lewy Body Parkinson Disease | Lewy Body DiseaseUnited States
-
University of PennsylvaniaNational Institute on Aging (NIA)RecruitingParkinson Disease | Lewy Body Dementia With Behavioral Disturbance | Lewy Body Parkinson Disease | Parkinson Disease DementiaUnited States
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingAlzheimer's Disease (AD) | Lewy Body Dementia (LBD) | Frontotemporal Degeneration (FTD)France
-
University of MichiganNational Institute on Aging (NIA)CompletedLewy Body Dementia With Behavioral Disturbance | Lewy Body Disease | Lewy Body Variant of Alzheimer DiseaseUnited States
-
Eisai Co., Ltd.Completed
-
University of California, San DiegoThe Lewy Body Dementia Association (LBDA)RecruitingDementia With Lewy Bodies | Lewy Body Dementia | Parkinson Disease DementiaUnited States
-
University of MichiganFarmer Family FoundationTerminatedParkinson Disease | Lewy Body Dementia | Parkinson Disease DementiaUnited States
-
Mayo ClinicRecruiting
-
Georgetown UniversityCompletedParkinson's Disease | Parkinson's Disease Dementia | Diffuse Lewy Body DiseaseUnited States
-
William Charles KreislNational Institute on Aging (NIA)CompletedDementia With Lewy Bodies | Parkinson's Disease Dementia | Diffuse Lewy Body DiseaseUnited States
Clinical Trials on Treadmill Walking
-
Georgia State UniversityRecruiting
-
Istanbul Medipol University HospitalCompleted
-
University of Erlangen-NürnbergGerman Foundation for Neurology; Department of Molecular Neurology, Faculty...Completed
-
Chulalongkorn UniversityCompletedParkinson's DiseaseThailand
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingSolid Tumors | Preoperative Aerobic TrainingUnited States
-
Arun Jayaraman, PT, PhDU.S. Department of EducationActive, not recruiting
-
University of VirginiaNot yet recruiting
-
Universitaet InnsbruckParacelsus Medical UniversityCompleted
-
Universita di VeronaUnknown
-
VA Office of Research and DevelopmentActive, not recruitingCVA (Cerebrovascular Accident)United States