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

NCT06339398 | Recruiting

• 1 other identifier: 002-2023
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Physical exercise; Brain-derived neurotrophic factor (BDNF)

Outcome Measures

Primary Outcomes (3)

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

  Change from baseline (T0) in blood BDNF concentration

  4 weeks

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

  Change from baseline (T0) in blood BDNF concentration

  8 weeks

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

  Change from baseline (T0) in blood BDNF concentration

  12 weeks

Secondary Outcomes (66)

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

  4 weeks

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

  8 weeks

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

  12 weeks

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

  4 weeks

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

  8 weeks

Study Arms (2)

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

Behavioral: Aerobic exercise

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

Behavioral: Aerobic exercise

Interventions

Aerobic exercise BEHAVIORAL

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

Extensive Rehabilitation Group; Intensive Rehabilitation Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's Disease

You may qualify if:

• 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.

You may not qualify if:

• 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
• Uncontrolled hypertension (resting blood pressure \>150/90 mmHg)
• Individuals with orthostatic hypotension and systolic pressure in feet below 100 will be excluded. Orthostatic hypotension (OH) is a reduction in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg within 3 minutes of standing.
• Hypo- or hyperthyroidism (TSH \<0.5 or \>5.0 mU/L), abnormal liver function (AST or ALT more than 2 times the upper limit of normal, ULN), alteration of kidney function.
• Values of complete blood test out of range and abnormal value clinically significant as per clinical judgment.
• Recent use of psychotropic drugs (e.g. anxiolytics, hypnotics, benzodiazepines, antidepressants) in which the dosage was not stable for 28 days before screening
• Severe disease (requiring systemic treatment and/or hospitalization) in the last 4 weeks.
• Any other clinically significant medical condition, psychiatric condition, drug or alcohol abuse, laboratory evaluation or abnormality that, in the opinion of the investigators, would interfere with the subject's ability to participate in the study.
• Beck Depression Inventory II (BDI) score \> 28, indicating a severe depression that precludes the ability to exercise.
• (Only for women) State of pregnancy.
• Other disorders, injuries, diseases or conditions that may interfere with the ability to perform exercises (e.g. history of stroke, breathing problems, traumatic brain injury, orthopaedic injury or neuromuscular disease).

Sponsors & Collaborators

• Casa di Cura San Raffaele Cassino: lead
• IRCCS San Raffaele Roma: collaborator
• San Raffaele Telematic University: collaborator
• University of Rome Tor Vergata: collaborator
• University of Urbino "Carlo Bo": collaborator

Study Sites (1)

San Raffaele Cassino

Cassino, Frosinone, 03043, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maria Francesca De Pandis, MD,PhD

  San Raffaele Cassino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Francesca De Pandis, MD, PhD

CONTACT

0039 0776394740; maria.depandis@sanraffaele.it

Maria Gaglione

CONTACT

maria.gaglione@sanraffaele.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: February 11, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

IT (1)