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

ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-80
SponsorCasa di Cura San Raffaele Cassino

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Mini-Mental State Examination-MMSE ≥24

Disqualifiers

Diagnosis of neurological disorders not related to Parkinson's disease

Musculoskeletal diseases that could impair gait and execution of exercise program

Presence of known cardiovascular disease that can compromise the performance required by the protocol

Presence of diabetes or other metabolic and endocrine disease

Trial population

Patients with Parkinson's Disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Aerobic exercise

    Behavioral

    Standardized volume of aerobic exercise, measured as METs-minutes/week

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Extensive Rehabilitation Group1 intervention
Group B: Intensive Rehabilitation Group1 intervention

Trial outcomes

Primary outcomes

1

Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)

Change from baseline (T0) in blood BDNF concentration

Time frame
4 weeks
2

Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)

Change from baseline (T0) in blood BDNF concentration

Time frame
8 weeks
3

Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)

Change from baseline (T0) in blood BDNF concentration

Time frame
12 weeks

Secondary outcomes

1

Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)

Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L)

Time frame
4 weeks
2

Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)

Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L)

Time frame
8 weeks
3

Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)

Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L)

Time frame
12 weeks
4

Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin

Change from baseline (T0) in FNDC5/Irisin by peripheral blood samples (ng/mL)

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Casa di Cura San Raffaele Cassino

Lead sponsor

IRCCS San Raffaele Roma

Collaborator

San Raffaele Telematic University

Collaborator

University of Rome Tor Vergata

Collaborator

University of Urbino "Carlo Bo"

Collaborator

Source ClinicalTrials.gov
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