NCT03864393

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

February 26, 2019

Last Update Submit

July 26, 2021

Conditions

Keywords

walking economyfatigabilitypropulsion

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

EXPERIMENTAL

Individuals 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.

Other: Multimodal overground locomotor training

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).

Multimodal overground locomotor training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 22860899BACKGROUND
  • Pugh 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.

  • Pechstein 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.

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Andrew A Guccione, PT, PhD, DPT

    George Mason University

    PRINCIPAL INVESTIGATOR

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

Locations