Purpose

To learn more about physical exercise for people who have been diagnosed with Parkinson’s Disease (PD) within the last 3 years and who are not currently managed with medications to help us better understand what exercise guidelines should be used in the future.

Category

IRB Number
STUDY00000103
NCT Number
NCT04284436
Sponsor
Northwestern University -



Study Contact

Victoria Carranza
210-450-8907
carranzav@uthscsa.edu

Principal Investigator
Okeanis Vaou

Carolyn Paiz
210-450-8830
paizc@uthscsa.edu

Victoria Carranza
210-450-8907
carranzav@uthscsa.edu

Charlotte Rhodes
210-450-8454
rhodesc1@uthscsa.edu

Omalys Biggs Rodriguez
210-450-8456
biggsrodrigu@uthscsa.edu



Eligibility

Eligible Ages
40-80
Eligible Genders
Male and Female
Accepts Healthy Volunteers
No

Inclusion Criteria

    1. A diagnosis of Parkinson's Diseas within the last 3 years.
    2. Hoehn and Yahr stage less than 3
    3. Age 40-80 years

Exclusion Criteria

    1. Currently being treated with PD medications 
    2. Expected to require treatment with medication for PD in the first 6 months of the study.

    3. Presence of known cardiovascular, metabolic, or renal disease or individuals with major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease without medical clearance to participate in the exercise program.
    4. Uncontrolled hypertension (resting blood pressure >150/90 mmHg)
    5. Hypothyroidism (TSH >6.0 mU/L), abnormal liver function (AST or ALT more than 2 times the upper limit of normal), abnormal renal function (estimated glomerular filtration rate (eGFR) using the MDRD4 equation or the CKD-EPI equation <45mL/min/1.73m2 ).
    6. Serious illness (requiring systemic treatment and/or hospitalization) within the last 4 weeks.
    7. Individuals who have been exercising at greater than moderate intensity for 120 minutes or more per week consistently over the last 6 months will be excluded. 
    8. Known allergy to iodinated products.
    9. (For women only) Actively breast-feeding an infant, and/or pregnant, or plan to become pregnant in the next 12 months.
    10. Other disorders, injuries, diseases, or conditions that might interfere with ability to perform endurance exercises (e.g. history of stroke, respiratory problems, traumatic brain injury, orthopedic injury, or neuromuscular disease).


Study Design

  • 270 people with Parkinson's disease will be randomly assigned to one of 2 treatment arms (1:1 ratio).

                 1) moderate-intensity exercise: 60-65% HRmax
                 2)high-intensity exercise: 80-85% HRmax

  • The endurance exercise will be 4 days per week for approximately 40 minutes per session (30 minutes at target HR with a 5-minute warm up and 5-minute cool down).
  • The intervention will last 18 months. Subjects will be followed for 6 months after completing the 18 months of intervention and will complete 24-month assessments.

Arm Groups

Participants will be randomized to one of 2 groups:
         1) exercise 4x per week at 60-65% HRmax (moderate-intensity exercise)
         2) exercise 4x per week at 80-85% HRmax (high-intensity exercise)