NCT02236286

Brief Summary

This project will relate our new quantification of Freezing of Gait (FoG) in Parkinson's disease, using body worn inertial sensors (Aim I), with abnormalities in state-of-the-art, resting state, functional brain connectivity (Aim II), and determine the number of subjects needed for a future, randomized clinical trial to test the efficacy of our novel, Agility Boot Camp (ABC) rehabilitation intervention for FoG (Aim III). The technological approaches to these aims are cutting edge and will allow us to develop sensitive behavioral and brain biomarkers for gait disorders in Parkinson's disease (PD) for use in future clinical trials.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

September 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

4 years

First QC Date

September 3, 2014

Last Update Submit

October 29, 2018

Conditions

Parkinson's Disease

Keywords

freezing of gait (FOG)balancegaitexercise

Outcome Measures

Primary Outcomes (1)

  • Change in Freezing of Gait Index

    Quantify amount of freezing in the legs ('trembling of knees'), defined as the square of the total power in the 3-8 Hz band, divided by the square of the total power in the 0.5-3 Hz band.

    Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)

Secondary Outcomes (8)

  • Change in the New Freezing of Gait Questionnaire (NFOGQ) score

    Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)

  • Change in PDQ-39 score

    Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)

  • Change in Activities of Balance Confidence (ABC) Questionnaire score

    Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)

  • Change in instrumented gait and balance measures

    Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)

  • Change in mini-BESTest score

    Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)

  • +3 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

Subjects will participate in a 90-minute, group (6 per group) exercise session 3 days per week for 6 weeks (18 sessions). The theoretical basis for our novel Agility Boot Camp (ABC) exercise program is based on research that identified the primary neurophysiological and cognitive constraints that limits balance and mobility in PD. The exercises are designed as a circuit with several types of movement-skills specifically focused on improving different postural domains with cognitive challenges such as memorized sequences and dual tasking.

Behavioral: Exercise

Chronic Disease Management Education

ACTIVE COMPARATOR

Subjects will also receive (cross-over) six weeks of educational classes. The Education program will teach subjects, chronic disease self-management - how to live better with their parkinsonism. Classes will consist of 6 subjects per group meeting for 90 minute sessions, once a week for six weeks. Subject will do an additional 120 minutes of relaxation at home/week.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.

Chronic Disease Management EducationExercise

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 50-90 years old.
  • No musculoskeletal or peripheral or central nervous system disorders (other than idiopathic Parkinson disease, iPD) that could significantly affect balance or gait .
  • Capable of following directions.
  • iPD subjects: United Kingdom Brain Bank criteria, i.e., bradykinesia and at least one of the following: rest tremor, muscular rigidity, and postural instability not cause by visual, vestibular, cerebellar or proprioceptive dysfunction. Unilateral onset, response to levodopa.

You may not qualify if:

  • Inability to stand or walk for 2 min without an assistive device
  • Recent changes in medication
  • Excessive use of alcohol or recreational drugs,
  • Contraindications to MRI scans (eg, claustrophobia, metal in body)
  • Intervention subjects will be excluded if: 1) participating in a vigorous exercise program more than 2 x/week, 2) A medical condition that contraindicates exercise participation.
  • Idiopathic PD subjects: Same as above and deep brain stimulation electrodes. Significant tremor that would interfere with MRI scan.
  • Control subjects:
  • Will be matched for age and gender to iPD group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Portland Health Care System (VAPORHCS)

Portland, Oregon, 97239, United States

Location

Related Publications (2)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PMID: 38588457DERIVED

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fay B Horak, PhD, PT

    VA Portland Health Care System (VAPORHCS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 10, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)