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Personalizing Exercise for Parkinson Disease (PEP)

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ClinicalTrials.gov Identifier: NCT04782518
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
American Parkinson Disease Association - Greater St. Louis Chapter
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease
Parkinson Disease

Detailed Description:

Parkinson Disease (PD) is a neurodegenerative disease that affects more than ten million people worldwide. In the United States, more than one million people are living with PD and more than 100,000 new cases are diagnosed each year.

Exercise to Ease the Burden of PD:

Exercise is an adjunct to pharmacologic therapy for PD that has been shown in many intensive research studies to help improve motor and non-motor symptoms in PD. A variety of Parkinson-specific exercise programs have been developed to help improve balance, posture, mobility, strength, endurance, speech, and/or self-help skills. These classes include various modes of exercise and different intensity levels, tailored for patients' personal characteristics and functional abilities.

Current Gaps in Knowledge and Aim:

The benefits of PD-specific exercise programs on physical function and disease-related quality of life have not been evaluated. Furthermore, many patients may not have access to PD-specific exercise programs. The proposed project addresses these gaps by exploring associations between PD-specific exercise programs and several metrics of physical function and quality of life among individuals with PD. In addition, the investigators are studying associations among overall exercise patterns, physical activity patterns, physical function, and quality of life among individuals with PD.

Study Involvement:

Participation in this study involves online surveys completed upon enrollment (i.e., baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years. A family member, caregiver, or friend may help the participant complete the online surveys.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Personalizing Exercise for Parkinson Disease
Actual Study Start Date : February 19, 2021
Estimated Primary Completion Date : February 18, 2024
Estimated Study Completion Date : February 18, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
Participants with PD
Adults with Parkinson Disease. This is an observational study without an intervention.



Primary Outcome Measures :
  1. Association between exercise patterns and quality of life [ Time Frame: Baseline ]
    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. Association between exercise patterns and mobility [ Time Frame: Baseline ]
    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).

  3. Association between exercise patterns and well-being [ Time Frame: Baseline ]
    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.

  4. Association between exercise patterns and quality of life [ Time Frame: 2 years ]
    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.

  5. Association between exercise patterns and mobility [ Time Frame: 2 years ]
    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).

  6. Association between exercise patterns and well-being [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Proportion of participants who attend a PD-specific exercise class [ Time Frame: Baseline ]
    Number of participants who attend a PD-specific exercise class relative to the total number of study participants.

  2. Frequency of participation in exercise classes or recreational exercise [ Time Frame: Baseline ]
    Frequency distribution of participation in exercise classes or recreational exercise, expressed on a weekly basis.

  3. Quality of Life score on the Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: Baseline ]
    Quality of Life summary index score on 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.

  4. Mobility score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire [ Time Frame: Baseline ]
    Mobility score will be computed from the Quality of Life in Neurological Disorders (Neuro-QOL) short form 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 8-40, with higher scores reflecting a higher level of lower extremity function and mobility (i.e., better self-reported health).

  5. Well-being score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire [ Time Frame: Baseline ]
    Well-being will be 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.

  6. Proportion of participants who attend a PD-specific exercise class [ Time Frame: 2 years ]
    Number of participants who attend a PD-specific exercise class relative to the total number of study participants.

  7. Frequency of participation in exercise classes or recreational exercise [ Time Frame: 2 years ]
    Frequency distribution of participation in exercise classes or recreational exercise, expressed on a weekly basis.

  8. Quality of Life score on the Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: 2 years ]
    Quality of Life summary index score on 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.

  9. Mobility score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire [ Time Frame: 2 years ]
    Mobility score will be computed from the Quality of Life in Neurological Disorders (Neuro-QOL) short form 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 8-40, with higher scores reflecting a higher level of lower extremity function and mobility (i.e., better self-reported health).

  10. Well-being score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire [ Time Frame: 2 years ]
    Well-being will be 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.


Other Outcome Measures:
  1. Age of participants (in years) [ Time Frame: Baseline ]
    Age of participants (years)

  2. Proportion of men and women [ Time Frame: Baseline ]
    Number of men and number of women relative to the total number of study participants

  3. State or country of residence [ Time Frame: Baseline ]
    State of residence (for those living in the United States) or country of residence (for those living outside the United States)

  4. Year of diagnosis of Parkinson Disease [ Time Frame: Baseline ]
    Year in which the participant was diagnosed as having Parkinson Disease

  5. Proportion of participants who tested positive for coronavirus [ Time Frame: Baseline ]
    Number of participants who tested positive for coronavirus relative to the total number of study participants. Coronavirus is the virus that causes coronavirus disease 2019 (COVID-19).

  6. Proportion of participants who have received a vaccine for coronavirus disease 2019 (COVID-19) [ Time Frame: Baseline ]
    Number of participants who have received a vaccine for coronavirus disease 2019 (COVID-19) relative to the total number of study participants.

  7. Proportion of participants who do not intend to receive a vaccine for coronavirus disease 2019 (COVID-19) [ Time Frame: Baseline ]
    Number of participants who do not intend to receive a vaccine for coronavirus disease 2019 (COVID-19) relative to the total number of study participants.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults who have been diagnosed by a physician as having Parkinson Disease are eligible to participate.
Criteria

Inclusion Criteria:

  • Diagnosis of Parkinson Disease
  • Ability to provide informed consent

Exclusion Criteria:

  • Children (<18 years of age)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782518


Contacts
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Contact: Susan B Racette, Ph.D. (314) 286-1424 racettes@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Susan B Racette, Ph.D.    314-286-1424    racettes@wustl.edu   
Principal Investigator: Susan B Racette, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
American Parkinson Disease Association - Greater St. Louis Chapter
Investigators
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Principal Investigator: Susan B Racette, Ph.D. Washington University School of Medicine
Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04782518    
Other Study ID Numbers: 202002075
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Aggregate data that contains no HIPPA identifiers will be made available as required if the request complies with all federal and Washington University School of Medicine policies for data sharing. Individual participant data (IPD) that may be shared include standardized survey scores, such as the Parkinson's Disease Questionnaire - 39 (PDQ-39) single index score, the PDQ-39 subscores, the Quality of Life in Neurological Disorders (Neuro-QoL) Lower Extremity Function - Mobility score, and the Neuro-QoL Positive Affect and Well-Being score. Any individual-level data that are shared will be de-identified.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
exercise
physical activity
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases