Dose-response Effects of Physical Exercise Standardized Volume on Peripheral Biomarkers, Clinical Response and Brain Connectivity in Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Observational
SUMMARY

This is a prospective, observational, cohort pilot study of standardize volume of aerobic exercise on changes in BDNF concentration at 4-weeks of exercise training among Parkinson disease patients. Thirty (N=30) participants will be consecutively enrolled and assigned to 2 groups: 1) Extensive Rehabilitation Group (exercise volume: 180 METs-min/week) or 2) Intensive Rehabilitation Group (exercise volume: 1350 METs-min/week). The primary objective is to evaluate the dose-response effects of two different rehabilitation settings, characterized by different workload (measured as energy expenditure), on blood BDNF levels.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
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• Diagnosis of Parkinson's Disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank

• Aged between 30 and 80 years

• Disease stage II-III in ON phase according to modified Hoehn and Yahr (H\&Y)

• Having no severe cognitive impairment:

‣ Mini-Mental State Examination-MMSE ≥24

⁃ Montreal Cognitive Assessment - MoCA ≥ 17/30

• Under stable dopaminergic pharmacological treatment

• Motor condition that permits to execute 6-Minutes Walking Test (6MWT)

• Willing to participate in the study, understand the procedures and sign the informed consent.

Locations
Other Locations
Italy
San Raffaele Cassino
RECRUITING
Cassino
Contact Information
Primary
Maria Francesca De Pandis, MD, PhD
maria.depandis@sanraffaele.it
0039 0776394740
Backup
Maria Gaglione
maria.gaglione@sanraffaele.it
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 30
Treatments
Extensive Rehabilitation Group
PD patients of Extensive Group will perform a 45-minutes daily session of low-intensity aerobic exercise of 2-3 METs (37%-45% VO 2max ; 57-63% HR max) twice a week, for a 4-weeks period. Exercise volume: 180 METs-minutes/week
Intensive Rehabilitation Group
PD patients of Intensive Rehabilitation Group will exercise for 45 minutes daily at high-intensity aerobic training of 6-8.8 METs (46-91% VO2max ; 76-95% HRmax), five days per week, for 4-weeks period. Exercise volume:1350 METs-minutes/week
Related Therapeutic Areas
Sponsors
Collaborators: University of Rome Tor Vergata, University of Urbino Carlo Bo, IRCCS San Raffaele Roma, San Raffaele Telematic University
Leads: Casa di Cura San Raffaele Cassino

This content was sourced from clinicaltrials.gov