Study in Parkinson Disease of Exercise

Conditions

• Parkinson Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Treadmill walking — BEHAVIORAL
  Treadmill walking 4 days per week for 30 minutes in the target heart rate

Study Details

This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. The primary objective is to test whether the progression of the signs of Parkinson's disease is attenuated at 12 months in among persons who have not initiated medication for Parkinson Disease (PD) when they perform high-intensity endurance treadmill exercise.

Key Dates

Start date

Aug 30, 2021

Status verified

Apr 2026

Primary completion

Jul 31, 2027

Completion

Jul 31, 2028

Study Design

Enrollment

370 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: High Intensity Exercise
  Treadmill exercise 4x per week at 80-85% HRmax.
• Active Comparator: Moderate Intensity Exercise
  Treadmill exercise 4x per week at 60-65% HRmax.

Primary Outcome Measure

Change in motor symptoms of Parkinson disease [ Time Frame: 12 months ]

Central Contacts

• Elizabeth Joslin
  309-922-7254
  [email protected]

Locations (24)

Find similar trials in Birmingham, AL

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