Personalizing Exercise for Parkinson Disease

Parkinson Disease Clinical Trial

— PEP  

Official title:

Personalizing Exercise for Parkinson Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04782518
• Other study ID #: 202002075
• Status: Active, not recruiting
• Start date: February 19, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 257
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Parkinson Disease

• Ability to provide informed consent

Exclusion Criteria:

• Children (<18 years of age)

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age of participants (in years)	Age of participants (years)	Baseline
Other	Proportion of men and women	Number of men and number of women relative to the total number of study participants	Baseline
Other	State or country of residence	State of residence (for those living in the United States) or country of residence (for those living outside the United States)	Baseline
Other	Year of diagnosis of Parkinson Disease	Year in which the participant was diagnosed as having Parkinson Disease	Baseline
Other	Proportion of participants who tested positive for coronavirus	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).	Baseline
Other	Proportion of participants who have received a vaccine for coronavirus disease 2019 (COVID-19)	Number of participants who have received a vaccine for coronavirus disease 2019 (COVID-19) relative to the total number of study participants.	Baseline
Other	Proportion of participants who do not intend to receive a vaccine for coronavirus disease 2019 (COVID-19)	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.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Proportion of participants who attend a PD-specific exercise class	Number of participants who attend a PD-specific exercise class relative to the total number of study participants.	Baseline
Secondary	Frequency of participation in exercise classes or recreational exercise	Frequency distribution of participation in exercise classes or recreational exercise, expressed on a weekly basis.	Baseline
Secondary	Quality of Life score on the Parkinson's Disease Questionnaire (PDQ-39)	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.	Baseline
Secondary	Mobility score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire	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).	Baseline
Secondary	Well-being score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire	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.	Baseline
Secondary	Proportion of participants who attend a PD-specific exercise class	Number of participants who attend a PD-specific exercise class relative to the total number of study participants.	2 years
Secondary	Frequency of participation in exercise classes or recreational exercise	Frequency distribution of participation in exercise classes or recreational exercise, expressed on a weekly basis.	2 years
Secondary	Quality of Life score on the Parkinson's Disease Questionnaire (PDQ-39)	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.	2 years
Secondary	Mobility score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire	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).	2 years
Secondary	Well-being score on the Quality of Life in Neurological Disorders (Neuro-QOL) questionnaire	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.	2 years