Clinical trial NCT04782518: Personalizing Exercise for Parkinson Disease
Official title: Personalizing Exercise for Parkinson Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson Disease
Keywords: exercise
physical activity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who have been diagnosed by a physician as having Parkinson Disease are eligible to participate.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson Disease
* Ability to provide informed consent

Exclusion Criteria:

* Children (\<18 years of age)

Primary outcomes:
measure: Association between exercise patterns and quality of life
timeFrame: Baseline
measure: Association between exercise patterns and mobility
timeFrame: Baseline
measure: Association between exercise patterns and well-being
timeFrame: Baseline
measure: Association between exercise patterns and quality of life
timeFrame: 2 years
measure: Association between exercise patterns and mobility
timeFrame: 2 years
measure: Association between exercise patterns and well-being
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of participants who attend a PD-specific exercise class
timeFrame: Baseline
measure: Frequency of participation in exercise classes or recreational exercise
timeFrame: Baseline
measure: Quality of Life score on the Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline
measure: Mobility score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire
timeFrame: Baseline
measure: Well-being score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire
timeFrame: Baseline
measure: Proportion of participants who attend a PD-specific exercise class
timeFrame: 2 years
measure: Frequency of participation in exercise classes or recreational exercise
timeFrame: 2 years
measure: Quality of Life score on the Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: 2 years
measure: Mobility score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire
timeFrame: 2 years
measure: Well-being score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire
timeFrame: 2 years
Other outcomes:
measure: Age of participants (in years)
timeFrame: Baseline
measure: Proportion of men and women
timeFrame: Baseline
measure: State or country of residence
timeFrame: Baseline
measure: Year of diagnosis of Parkinson Disease
timeFrame: Baseline
measure: Proportion of participants who tested positive for coronavirus
timeFrame: Baseline
measure: Proportion of participants who have received a vaccine for coronavirus disease 2019 (COVID-19)
timeFrame: Baseline
measure: Proportion of participants who do not intend to receive a vaccine for coronavirus disease 2019 (COVID-19)
timeFrame: Baseline
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Susan B Racette, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.