Exercise for People With Parkinson's Disease

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Behavioral: Aerobic Exercise; Behavioral: Flexibility and Function exercise program; Behavioral: Home exercise program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01257945

02-0750

R01HD043770

Details and patient eligibility

About

This randomized, controlled exercise intervention with three groups compares two exercise approaches to standard of care. Supervised interventions are administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. Functional outcomes are measured at the completion of the supervised exercise (4 months) as well as 10 and 16 months.

Full description

This randomized, controlled exercise intervention study compares physical therapy interventions for people in early and mid-stages of Parkinson's disease. Two different approaches to exercise are compared to standard of care. The two exercise programs consist of supervised interventions, administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. The standard of care program consists of a home program in which participants exercise in a group setting once a month with an exercise trainer. Functional outcomes are measured at the completion of the supervised exercise at 4 months as well as 10 and 16 months. This study is the first long term exercise study for people with Parkinson's disease PD of which we are aware and is the most comprehensive examination of exercise for people with PD to date. Results of this study will provide definitive information regarding the best approach to exercise for people in early and mid stages of PD, both in terms of immediate 4 month and long term 16 month effects.

Enrollment: 163 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Parkinson's Disease
• Hoehn & Yahr stages 1-3.5

Exclusion criteria

• Cardiovascular contraindications to aerobic exercise
• Reliance on walker or wheelchair
• Psychiatric conditions
• DBS or other surgeries
• Any other conditions that would interfere with exercise

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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163 participants in 3 patient groups

Flexibility & Function

Experimental group

Description:

Subjects take part in an exercise program based on flexibility and function.

Treatment:

Behavioral: Flexibility and Function exercise program

Aerobic Exercise

Experimental group

Description:

Subjects will take part in an aerobic exercise program

Treatment:

Behavioral: Aerobic Exercise

Home exercise

Other group

Description:

Standard of care home exercise program

Treatment:

Behavioral: Home exercise program