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How different amounts of exercise affect the body and brain

Researchers follow an exercise programme and measure changes in symptoms, biological markers and connections between brain areas in Parkinson’s.

Learning by observing or collecting information · Study reference: NCT06339398

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Start (reported actual date)
2025-02-11
Main measurements finished (planned)
2027-12-31
Study finished (planned)
2028-05-31

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 30 years to 80 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Full study name & original research details

Official study title

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

Short title used by the registry

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

Original description

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.

Further description from the registry

This pilot observational study will evaluate the dose-response relationship between the volume of exercise, measured as METs-minutes/week, of two different rehabilitation settings to quantify the change in BDNF concentration in PD patients. The study will also compare the changes induced by extensive and intensive rehabilitation settings in other neurotrophic factors and peripheral biomarkers, on motor and non-motor symptoms, kinematic parameters of gait, cognitive function, quality of life and the changes in cortical activity assessed with electroencephalogram (EEG) and in brain connectivity by functional magnetic resonance imaging (fMRI).

Conditions reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Observational
Interventions
Aerobic exercise
Phases
Not reported
Sponsor
Casa di Cura San Raffaele Cassino
Start date reported by registry
2025-02-11 (actual)

Registry updated: 2026-09-02 · Status last verified by the registry submitter: 2026-06

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Maria Francesca De Pandis, MD, PhD · 0039 0776394740 · maria.depandis@sanraffaele.it

Maria Gaglione · maria.gaglione@sanraffaele.it

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

San Raffaele Cassino

Cassino, Frosinone, Italy

Recruiting

Maria Francesca De Pandis, MD, PhD · 0039 0776394740 · maria.depandis@sanraffaele.it

Maria Gaglione · maria.gaglione@sanraffaele.it

Facility not reported

Italy

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.