NCT03972969

Brief Summary

This study will test the hypothesis that two highly challenging exercise programs, one based at the VA medical center and the other conducted remotely, will both significantly reduce overall fall rates in patients with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

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

First Submitted

Initial submission to the registry

May 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 21, 2024

Completed
Last Updated

June 21, 2024

Status Verified

February 1, 2024

Enrollment Period

3.4 years

First QC Date

May 31, 2019

Results QC Date

February 28, 2024

Last Update Submit

February 28, 2024

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseExercise therapyAccidental falls

Outcome Measures

Primary Outcomes (1)

  • Number of Falls Over 3 Month Period

    Total number of falls from baseline to the 3-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.

    Baseline to 3 months

Secondary Outcomes (1)

  • Number of Falls Over 6 Month Period

    Baseline to 6 months

Study Arms (3)

In-person exercise group

EXPERIMENTAL

facility-based structured exercise program

Behavioral: Facility-based structured exercise

Remote exercise group

EXPERIMENTAL

home-based structured exercise program

Behavioral: Home-based structured exercise

Control group

ACTIVE COMPARATOR

health education

Behavioral: Health education

Interventions

Facility-based structured exerciseBEHAVIORAL

Structured exercise program in a facility with instruction and encouragement

In-person exercise group
Home-based structured exerciseBEHAVIORAL

Structured exercise program in the home with instruction and encouragement

Remote exercise group
Health educationBEHAVIORAL

Provision of general information about a variety of topics

Control group

Eligibility Criteria

Age40 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician diagnosis of idiopathic PD
  • At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)
  • Response to dopaminergic medication

You may not qualify if:

  • Angina pectoris
  • History of myocardial infarction (MI) within 6 months
  • History of ventricular dysrhythmia requiring current therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, 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 Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. David Sparrow
Organization
VA Boston Healthcare System
david.sparrow@va.gov
857-364-6407

Study Officials

  • David Sparrow, DSc

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 4, 2019

Study Start

October 1, 2019

Primary Completion

February 28, 2023

Study Completion

July 31, 2023

Last Updated

June 21, 2024

Results First Posted

June 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)