Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT04782518
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2021-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalizing Exercise for Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age of participants (in years)', 'timeFrame': 'Baseline', 'description': 'Age of participants (years)'}, {'measure': 'Proportion of men and women', 'timeFrame': 'Baseline', 'description': 'Number of men and number of women relative to the total number of study participants'}, {'measure': 'State or country of residence', 'timeFrame': 'Baseline', 'description': 'State of residence (for those living in the United States) or country of residence (for those living outside the United States)'}, {'measure': 'Year of diagnosis of Parkinson Disease', 'timeFrame': 'Baseline', 'description': 'Year in which the participant was diagnosed as having Parkinson Disease'}, {'measure': 'Proportion of participants who tested positive for coronavirus', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Proportion of participants who have received a vaccine for coronavirus disease 2019 (COVID-19)', 'timeFrame': 'Baseline', 'description': 'Number of participants who have received a vaccine for coronavirus disease 2019 (COVID-19) relative to the total number of study participants.'}, {'measure': 'Proportion of participants who do not intend to receive a vaccine for coronavirus disease 2019 (COVID-19)', 'timeFrame': 'Baseline', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Association between exercise patterns and quality of life', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Association between exercise patterns and mobility', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Association between exercise patterns and well-being', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Association between exercise patterns and quality of life', 'timeFrame': '2 years', 'description': "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."}, {'measure': 'Association between exercise patterns and mobility', 'timeFrame': '2 years', 'description': '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).'}, {'measure': 'Association between exercise patterns and well-being', 'timeFrame': '2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants who attend a PD-specific exercise class', 'timeFrame': 'Baseline', 'description': 'Number of participants who attend a PD-specific exercise class relative to the total number of study participants.'}, {'measure': 'Frequency of participation in exercise classes or recreational exercise', 'timeFrame': 'Baseline', 'description': 'Frequency distribution of participation in exercise classes or recreational exercise, expressed on a weekly basis.'}, {'measure': "Quality of Life score on the Parkinson's Disease Questionnaire (PDQ-39)", 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Mobility score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Well-being score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Proportion of participants who attend a PD-specific exercise class', 'timeFrame': '2 years', 'description': 'Number of participants who attend a PD-specific exercise class relative to the total number of study participants.'}, {'measure': 'Frequency of participation in exercise classes or recreational exercise', 'timeFrame': '2 years', 'description': 'Frequency distribution of participation in exercise classes or recreational exercise, expressed on a weekly basis.'}, {'measure': "Quality of Life score on the Parkinson's Disease Questionnaire (PDQ-39)", 'timeFrame': '2 years', 'description': "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."}, {'measure': 'Mobility score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire', 'timeFrame': '2 years', 'description': '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).'}, {'measure': 'Well-being score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire', 'timeFrame': '2 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'physical activity'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '20090375', 'type': 'BACKGROUND', 'citation': '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': '24002341', 'type': 'BACKGROUND', 'citation': "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': '29858216', 'type': 'BACKGROUND', 'citation': "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': '30477861', 'type': 'BACKGROUND', 'citation': "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': '9351479', 'type': 'BACKGROUND', 'citation': "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': '9010413', 'type': 'BACKGROUND', 'citation': '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': '8588541', 'type': 'BACKGROUND', 'citation': "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': '7613534', 'type': 'BACKGROUND', 'citation': "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': '11509307', 'type': 'BACKGROUND', 'citation': "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': '10690694', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nExercise to Ease the Burden of PD:\n\nExercise 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.\n\nCurrent Gaps in Knowledge and Aim:\n\nThe 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.\n\nStudy Involvement:\n\nParticipation 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults who have been diagnosed by a physician as having Parkinson Disease are eligible to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Parkinson Disease\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Children (\\<18 years of age)'}, 'identificationModule': {'nctId': 'NCT04782518', 'acronym': 'PEP', 'briefTitle': 'Personalizing Exercise for Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Personalizing Exercise for Parkinson Disease', 'orgStudyIdInfo': {'id': '202002075'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with PD', 'description': 'Adults with Parkinson Disease. This is an observational study without an intervention.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Susan B Racette, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}