Effect of Multimodal Exercise Training on Walking Economy in Individuals With Parkinson's Disease
Effect of a 12-week Multimodal Exercise Intervention on Walking Economy, Fatigability, and Propulsion in Individuals With Parkinson's Disease
1 other identifier
interventional
17
1 country
1
Brief Summary
Sustained ambulation is a challenge for individuals with Parkinson's disease (PD) as walking economy is frequently compromised. There are also various disease-related skeletal muscle alterations that may contribute to performance fatigability during ambulation. Concomitantly, individuals with PD experience substantial difficulty maintaining sustained forward progression at push-off during the gait cycle due to diminished force production. Exercise is commonly prescribed for these individuals, though traditional exercise approaches to PD have often applied a "one impairment-one modality" paradigm that addresses each impairment separately. Interventions to optimize movement should facilitate an individual's response to the challenge of responding to a complex interplay of constraints that are also specific to a task and its environmental context. Thus, there are multiple concurrent targets for exercise interventions that may not fit easily within a "one impairment-one modality" model. A multimodal intervention is designed to address an array of constraining impairments concurrently. However, the evidence-base for multimodal exercise approaches is still developing and far from conclusive. The purpose of this study is to demonstrate that multimodal overground locomotion training (OLT) can promote walking economy during sustained overground ambulation in individuals with PD, and produce concurrent secondary effects that decrease performance fatigability and increase propulsion. The aims of this study are to 1) Evaluate walking economy during sustained overground walking after 12 weeks of multimodal OLT, 2) Evaluate secondary effects of OLT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started May 2019
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
March 6, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2020
CompletedJuly 27, 2021
July 1, 2021
11 months
February 26, 2019
July 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Walking Economy
measured as oxygen consumption (VO2) over distance walked (meters) during a 10-minute walk test
pre and post 12 week intervention protocol
Secondary Outcomes (9)
Change in Performance Fatigability
pre and post 12 week intervention protocol
Change in Propulsion
pre and post 12 week intervention protocol
Change in Interlimb Coordination
pre and post 12 week intervention protocol
Change in Muscle Activation
pre and post 12 week intervention protocol
Change in Perceived Fatigability
pre and post 12 week intervention protocol
- +4 more secondary outcomes
Study Arms (1)
Multimodal overground locomotor training
EXPERIMENTALIndividuals with Parkinson's Disease that meet the inclusion/exclusion criteria and enrolled in the study will participate in a 12-week multimodal exercise training intervention performed twice per week.
Interventions
Locomotor training sessions use various movement drills emphasizing power, stability, and stepping in a specific direction: forward, backward, lateral, rotational. Sessions also have an additional focus on gait initiation or steady-state walking. After circuit-style warm up exercises, participants perform overground movement drills that are specific to the emphasis of the individual training session, culminating in practicing everyday overground walking. Participants wear a heart rate monitor to ensure that the majority of the training session is performed at an aerobic intensity greater than 60% age predicted heart rate maximum (220-age +/- 5 bpm).
Eligibility Criteria
You may qualify if:
- years of age or older
- diagnosis of idiopathic Parkinson's Disease, mild to moderate (Hoehn and Yahr score less than or equal to 3)
- speaks English
- able to ambulate without requiring an assistive device
You may not qualify if:
- neurological disease diagnosis other than PD
- uncontrolled cardiovascular, pulmonary, neurological, or metabolic disease which may impact the ability to exercise or in which exercise is contraindicated
- any medications, such as beta-blockers, that may alter HR or metabolic data
- cognitive or psychiatric impairment precluding informed consent or ability to following instructions
- mini-Mental State Examination score \<24
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
George Mason University
Fairfax, Virginia, 22030, United States
Related Publications (3)
Schnelle JF, Buchowski MS, Ikizler TA, Durkin DW, Beuscher L, Simmons SF. Evaluation of two fatigability severity measures in elderly adults. J Am Geriatr Soc. 2012 Aug;60(8):1527-33. doi: 10.1111/j.1532-5415.2012.04062.x. Epub 2012 Aug 2.
PMID: 22860899BACKGROUNDPugh RJ, Higgins RD, Min H, Wutzke CJ, Guccione AA. Turns while walking among individuals with Parkinson's disease following overground locomotor training: A pilot study. Clin Biomech (Bristol). 2024 Apr;114:106234. doi: 10.1016/j.clinbiomech.2024.106234. Epub 2024 Apr 3.
PMID: 38582028DERIVEDPechstein AE, Gollie JM, Keyser RE, Guccione AA. Walking Endurance and Oxygen Uptake On-Kinetics in Individuals With Parkinson Disease Following Overground Locomotor Training. J Neurol Phys Ther. 2023 Apr 1;47(2):99-111. doi: 10.1097/NPT.0000000000000423. Epub 2022 Dec 19.
PMID: 36538418DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew A Guccione, PT, PhD, DPT
George Mason University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2019
First Posted
March 6, 2019
Study Start
May 1, 2019
Primary Completion
March 30, 2020
Study Completion
March 30, 2020
Last Updated
July 27, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share