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

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ClinicalTrials.gov Identifier: NCT02268617
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : September 27, 2016
Information provided by (Responsible Party):
Anne Kloos, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Huntington Disease Lewy Body Disease Other: Treadmill Walking Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Effects of Treadmill Walking in Individuals With Dementia With Lewy Bodies and Huntington's Disease
Study Start Date : February 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Treadmill Walking
All subjects will walk on treadmill for a total of 20 minutes.
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268617

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United States, Ohio
The Ohio State University Physical Therapy Division
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
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Principal Investigator: Anne Kloos, PhD Ohio State University
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Responsible Party: Anne Kloos, Associate Clinical Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02268617    
Other Study ID Numbers: 2012H0385
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Anne Kloos, Ohio State University:
Additional relevant MeSH terms:
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Huntington Disease
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Parkinsonian Disorders