NCT04782518

Brief Summary

The overarching aim is to determine the benefits of Parkinson-specific exercise programs and general exercise patterns on physical function and disease-related quality of life among people with Parkinson Disease (PD). The significance of this project is that millions of individuals experience adverse consequences of PD and there is strong evidence that structured exercise programs have beneficial effects on motor function and PD-related quality of life. Participation in this study involves online surveys upon enrollment (i.e., baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 19, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

4.5 years

First QC Date

February 25, 2021

Last Update Submit

May 24, 2024

Conditions

Keywords

exercisephysical activity

Outcome Measures

Primary Outcomes (6)

  • Association between exercise patterns and quality of life

    Association between exercise patterns (including exercise type and frequency) and quality of life, as assessed by the Parkinson's Disease Questionnaire (PDQ-39). The score range for the PDQ-39 is 0 to 100, with lower scores reflecting higher quality of life.

    Baseline

  • Association between exercise patterns and mobility

    Association between exercise patterns (including exercise type and frequency) and mobility, as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire. The Neuro-QOL short form domain on Lower Extremity Function - Mobility will be used. The score range for the Neuro-QOL Mobility domain is 8 to 40, with higher scores reflecting a higher level of lower extremity function and mobility (i.e., better self-reported health).

    Baseline

  • Association between exercise patterns and well-being

    Association between exercise patterns (including exercise type and frequency) and well-being, as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire. The Neuro-QOL short form domain on Positive Affect and Well-Being will be used. The score range for the Neuro-QOL Positive Affect and Well-Being domain is 9 to 45, with higher scores reflecting a higher level of well-being.

    Baseline

  • Association between exercise patterns and quality of life

    Association between exercise patterns (including exercise type and frequency) and quality of life, as assessed by the Parkinson's Disease Questionnaire (PDQ-39). The score range for the PDQ-39 is 0 to 100, with lower scores reflecting higher quality of life.

    2 years

  • Association between exercise patterns and mobility

    Association between exercise patterns (including exercise type and frequency) and mobility, as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire. The Neuro-QOL short form domain on Lower Extremity Function - Mobility will be used. The score range for the Neuro-QOL Mobility domain is 8 to 40, with higher scores reflecting a higher level of lower extremity function and mobility (i.e., better self-reported health).

    2 years

  • Association between exercise patterns and well-being

    Association between exercise patterns (including exercise type and frequency) and well-being, as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire. The Neuro-QOL short form domain on Positive Affect and Well-Being will be used. The score range for the Neuro-QOL Positive Affect and Well-Being domain is 9 to 45, with higher scores reflecting a higher level of well-being.

    2 years

Secondary Outcomes (10)

  • Proportion of participants who attend a PD-specific exercise class

    Baseline

  • Frequency of participation in exercise classes or recreational exercise

    Baseline

  • Quality of Life score on the Parkinson's Disease Questionnaire (PDQ-39)

    Baseline

  • Mobility score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire

    Baseline

  • Well-being score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire

    Baseline

  • +5 more secondary outcomes

Other Outcomes (7)

  • Age of participants (in years)

    Baseline

  • Proportion of men and women

    Baseline

  • State or country of residence

    Baseline

  • +4 more other outcomes

Study Arms (1)

Participants with PD

Adults with Parkinson Disease. This is an observational study without an intervention.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults who have been diagnosed by a physician as having Parkinson Disease are eligible to participate.

You may qualify if:

  • Diagnosis of Parkinson Disease
  • Ability to provide informed consent

You may not qualify if:

  • Children (\<18 years of age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (10)

  • Wright Willis A, Evanoff BA, Lian M, Criswell SR, Racette BA. Geographic and ethnic variation in Parkinson disease: a population-based study of US Medicare beneficiaries. Neuroepidemiology. 2010;34(3):143-51. doi: 10.1159/000275491. Epub 2010 Jan 15.

    PMID: 20090375BACKGROUND
  • Nadeau A, Pourcher E, Corbeil P. Effects of 24 wk of treadmill training on gait performance in Parkinson's disease. Med Sci Sports Exerc. 2014 Apr;46(4):645-55. doi: 10.1249/MSS.0000000000000144.

    PMID: 24002341BACKGROUND
  • Ramaswamy B, Jones J, Carroll C. Exercise for people with Parkinson's: a practical approach. Pract Neurol. 2018 Oct;18(5):399-406. doi: 10.1136/practneurol-2018-001930. Epub 2018 Jun 1.

    PMID: 29858216BACKGROUND
  • Rossi A, Torres-Panchame R, Gallo PM, Marcus AR, States RA. What makes a group fitness program for people with Parkinson's disease endure? A mixed-methods study of multiple stakeholders. Complement Ther Med. 2018 Dec;41:320-327. doi: 10.1016/j.ctim.2018.08.012. Epub 2018 Aug 31.

    PMID: 30477861BACKGROUND
  • Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N. The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997 Sep;26(5):353-7. doi: 10.1093/ageing/26.5.353.

    PMID: 9351479BACKGROUND
  • Fitzpatrick R, Jenkinson C, Peto V, Hyman N, Greenhall R. Desirable properties for instruments assessing quality of life: evidence from the PDQ-39. J Neurol Neurosurg Psychiatry. 1997 Jan;62(1):104. doi: 10.1136/jnnp.62.1.104. No abstract available.

    PMID: 9010413BACKGROUND
  • Jenkinson C, Peto V, Fitzpatrick R, Greenhall R, Hyman N. Self-reported functioning and well-being in patients with Parkinson's disease: comparison of the short-form health survey (SF-36) and the Parkinson's Disease Questionnaire (PDQ-39). Age Ageing. 1995 Nov;24(6):505-9. doi: 10.1093/ageing/24.6.505.

    PMID: 8588541BACKGROUND
  • Peto V, Jenkinson C, Fitzpatrick R, Greenhall R. The development and validation of a short measure of functioning and well being for individuals with Parkinson's disease. Qual Life Res. 1995 Jun;4(3):241-8. doi: 10.1007/BF02260863.

    PMID: 7613534BACKGROUND
  • Peto V, Jenkinson C, Fitzpatrick R. Determining minimally important differences for the PDQ-39 Parkinson's disease questionnaire. Age Ageing. 2001 Jul;30(4):299-302. doi: 10.1093/ageing/30.4.299.

    PMID: 11509307BACKGROUND
  • Harrison JE, Preston S, Blunt SB. Measuring symptom change in patients with Parkinson's disease. Age Ageing. 2000 Jan;29(1):41-5. doi: 10.1093/ageing/29.1.41.

    PMID: 10690694BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Susan B Racette, Ph.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 4, 2021

Study Start

February 19, 2021

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations