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

Not Applicable

Completed

• Conditions: Lewy Body Disease; Huntington Disease
• Interventions: Other: Treadmill Walking

• Registration Number: NCT02268617
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-15
• Study First Posted: 2014-10-20
• Primary Completion: 2016-08
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treadmill Walking	Treadmill Walking	All subjects will walk on treadmill for a total of 20 minutes.

Primary Outcome Measures

Name	Time	Method
Vital signs	Within 24 hours	Blood pressure, heart rate, and rating of perceived exertion will be measured before, during, and after treadmill walking.

Secondary Outcome Measures

Name	Time	Method
Spatiotemporal gait measures	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	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	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.

Trial Locations

Locations (1)

The Ohio State University Physical Therapy Division; 🇺🇸 Columbus, Ohio, United States