NCT03189680

Brief Summary

To determine the effects of an unusually highly intensity and individualized sensorimotor and visuomotor agility exercise program on non-demented PD patients' clinical symptoms, mobility, and postural stability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started May 2015

Typical duration 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

Study Start

First participant enrolled

May 11, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

May 1, 2020

Status Verified

June 1, 2017

Enrollment Period

2.1 years

First QC Date

May 31, 2017

Last Update Submit

April 29, 2020

Conditions

Parkinson Disease

Keywords

sensorimotor trainingexergamingposturequality of life

Outcome Measures

Primary Outcomes (1)

  • EQ5D-5L

    Questionnaire

    0-5 scale (3 week-long, higher number is better)

Study Arms (3)

Exercise therapy

EXPERIMENTAL

Parkinson's disease group that receive 3 weeks of intensive exercise therapy in a rehabilitation center.

Other: Exercise therapy

Control

NO INTERVENTION

Parkinson's disease control group that will not receive exercise treatment.

Healthy

NO INTERVENTION

A healthy group whose results will be compared with Parkinson's disease groups.

Interventions

Exercise therapyOTHER

3-week-long intervention, administered daily, targeted postural instability and mobility using at-limit intensity sensorimotor and visuomotor agility training

Also known as: Control
Exercise therapy

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease
  • Hoenh Yahr scale of 2-3
  • Instability problem

You may not qualify if:

  • Severe heart problems
  • Severe demeanor
  • Alcoholism
  • Drug problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Somogy Megyei Kaposi Mór Teaching Hospital

Kaposvár, Somogy County, 7400, Hungary

Location

Related Publications (3)

  • 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

  • Tollar J, Nagy F, Kovacs N, Hortobagyi T. Two-Year Agility Maintenance Training Slows the Progression of Parkinsonian Symptoms. Med Sci Sports Exerc. 2019 Feb;51(2):237-245. doi: 10.1249/MSS.0000000000001793.

    PMID: 30303934DERIVED

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The single-arm, 3-week-long intervention, administered daily, targeted postural instability and mobility using at-limit intensity sensorimotor and visuomotor agility training (n = 35, 17 males) conceptualized but seldom implemented previously. Each of the 15 training sessions lasted 60 minutes. Patients performed each exercise under increasingly difficult conditions and speed according to principles of periodization. All patients kept an exercise log detailing the positive and negative effects of the intervention on clinical and motor symptoms. The logs and attendance were checked daily. The no-intervention control, consisting of PD patients (n = 20, 12 males) received unsupervised standard care, consisting of the prescribed medications and daily, unsupervised 30 minutes of exercises at home.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 16, 2017

Study Start

May 11, 2015

Primary Completion

May 31, 2017

Study Completion

June 30, 2017

Last Updated

May 1, 2020

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)