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Treadmill Walking in Individuals With Dementia With Lewy Bodies and Huntington's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02268617
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Anne Kloos, Ohio State University

Tracking Information
First Submitted Date  ICMJE October 10, 2014
First Posted Date  ICMJE October 20, 2014
Last Update Posted Date September 27, 2016
Study Start Date  ICMJE February 2013
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treadmill Walking in Individuals With Dementia With Lewy Bodies and Huntington's Disease
Official Title  ICMJE Immediate Effects of Treadmill Walking in Individuals With Dementia With Lewy Bodies and Huntington's Disease
Brief Summary Individuals with Dementia with Lewy Bodies (DLB) and Huntington's disease (HD) experience balance and walking problems that lead to falls. Treadmill walking has demonstrated improvements in balance and walking and fall risk in individuals with Parkinson's disease (PD), suggesting that it may be beneficial for individuals with DLB and HD. In PD subjects, changes in gait parameters have been noted after only one treadmill training session. The investigators propose a pilot study to investigate the safety, feasibility, and utility to improve mobility and fall risk of a single session of treadmill walking in individuals with DLB and HD.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Huntington Disease
  • Lewy Body Disease
Intervention  ICMJE Other: Treadmill Walking
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.
Study Arms  ICMJE Experimental: Treadmill Walking
All subjects will walk on treadmill for a total of 20 minutes.
Intervention: Other: Treadmill Walking
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2016)
28
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2014)
30
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02268617
Other Study ID Numbers  ICMJE 2012H0385
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Anne Kloos, Ohio State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ohio State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne Kloos, PhD Ohio State University
PRS Account Ohio State University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP