bèta
Trial Radar AI
De klinische studie NCT05720468 (EXCEL-PD) voor Parkinson ziekte is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
Eén studie komt overeen met de filtercriteria
Kaartweergave

Exercise for Cognitive Excellence in Parkinson's Disease (EXCEL-PD)

Recruterend
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT05720468 (EXCEL-PD) is een interventioneel studie bij Parkinson ziekte met de status recruterend. Het doel is om 32 deelnemers te includeren vanaf 20 juli 2023. De studie wordt geleid door de Universiteit van Californië, San Francisco en de voltooiing is gepland op 31 januari 2026. Laatste update op ClinicalTrials.gov: 20 oktober 2025.
Beknopte samenvatting
This study will evaluate the safety and feasibility of a home-based, virtually-supervised, combined high intensity endurance and resistance training program in people with Parkinson's disease. It will also evaluate the effects of exercise on cognition and underlying exercise-related biological markers (biomarkers).
Uitgebreide beschrijving
Cognitive impairment begins early in Parkinson's disease (PD) and progresses to dementia in a majority of patients, impairing quality of life and contributing to growing health-related costs. Physical exercise has potent anti-aging effects and improves many outcomes in PD including cognition. Identifying biomarkers that respond to exercise, and how they associate with cognition and underlying disease pathology, may elucidate key mechanisms for countering cognitive decline. This is a randomized-controlled trial that evaluates safety and feasibility of a home-based exercise intervention in people with PD and measure its effects on cognition and circulating biomarkers of aging and stress. Thirty-two participants with PD will be randomized to receive a home-based, trainer-supervised endurance and resistance training program (exercise group) or no exercise (wait list control group) for 26 weeks. Cognitive assessments and patient reported outcomes will be obtained at baseline and at end of 26 weeks. Biomarkers in periphery (blood, saliva) and brain [cerebrospinal fluid (CSF)] will also be measured before and after the 26-week exercise intervention.
Officiële titel

Exercise for Cognitive Excellence in Parkinson's Disease

Aandoeningen
Parkinson ziekte
Andere studie-ID's
NCT-ID
Startdatum (Werkelijk)
2023-07-20
Laatste update geplaatst
2025-10-20
Verwachte einddatum
2026-01-31
Inschrijving (Geschat)
32
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelExercise
Participants randomized to the exercise group will receive 26 weeks of home-based, combined endurance and resistance training program under guidance and virtual supervision from exercise trainers. Exercise will be performed 5 days per week, with 3 days of endurance training using treadmill and 2 days of resistance training.
Oefening
Combined endurance and resistance exercise training
Placebo-comparatorWaitlist Control Group
The control group will continue usual level of physical activity the participants were doing prior to enrollment in the study. At the end of the 26 week study period, participants will be offered the chance to participate in the same home-based, combined endurance and resistance training program.
Geen oefening
Continue usual level of physical activity; option to participate in exercise training program after 26-week intervention period
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Average percent heart rate maximum (HR max)
The overall average percent HR max will be compared to the target percent HR max (80-85 percent).
From weeks 5-26, every exercise session
Average repetition maximum
The overall average repetition maximum for resistance exercise will be compared to the target repetition maximum (10-repetition maximum)
From weeks 5-26, every exercise session
Average number of days per week exercised
The average number of days per week exercised will be compared to target adherence (5 days/week of exercise)
From weeks 5-26, every week
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Change in cognitive function
Change from baseline in Montreal Cognitive Assessment (MoCA). MoCA scores range between 0 and 30, with higher scores representing a better outcome.
Baseline and 26 weeks
Change in motor symptoms of Parkinson's disease
Change from baseline in the Movement Disorders Society-Unified Parkinson Disease Rating Scale motor score (Part III). The minimum score on the MDS-UPDRS Part III is 0 and the maximum is 132 with higher scores representing worse motor symptoms.
26 weeks
Change in biomarker of aging
Change from baseline in blood levels of klotho
Baseline and 26 weeks
Change in biomarker of aging
Change from baseline in CSF levels of klotho
Baseline and 26 weeks
Change in biomarker of stress
Change from baseline in saliva levels of cortisol
Baseline and 26 weeks
Change in biomarker of stress
Change from baseline in CSF levels of cortisol
Baseline and 26 weeks
Change in biomarker of inflammation
Change from baseline in blood levels of CRP
Baseline and 26 weeks
Change in biomarker of inflammation
Change from baseline in CSF levels of CRP
Baseline and 26 weeks
Change in neurotrophic biomarker
Change from baseline in blood levels of BDNF
Baseline and 26 weeks
Change in neurotrophic biomarker
Change from baseline in CSF levels of BDNF
Baseline and 26 weeks
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
40 Years
Geslachten die in aanmerking komen voor de studie
Allen
  1. Diagnosis of idiopathic Parkinson's disease (PD) based on MDS criteria, with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism.
  2. Modified Hoehn and Yahr stage less than 4
  3. Age 40-80 years at time of screening
  4. If being treated with PD symptomatic medications (i.e.g., rasagiline, carbidopa/levodopa, dopamine agonists, amantadine, anti-cholinergics), stable doses for greater than or equal to 2 months prior to baseline. If not being treated with PD symptomatic medication at time of screening, deemed unlikely to require symptomatic medication for next 6 months.

  1. A diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia or other diagnoses that explain symptoms other than PD.

  2. A diagnosis of a significant neurological disease other than PD that would interfere with ability to perform study procedures or assessments.

  3. Significant cognitive impairment defined as Montreal Cognitive Assessment (MoCA)<23 or any impairment that would, in the opinion of the investigator, interfere with ability to follow exercise directions.

  4. Beck Depression Inventory II (BDI) score > 16, indicating depression that precludes ability to exercise.

  5. Use of neuroleptics/dopamine receptor blockers for more than 30 days in the year prior to baseline visit, or any use within 30 days of baseline visit.

  6. Recent use of psychotropic medications (e.g., recent use of psychotropic medications (i.e., anxiolytics, hypnotics, benzodiazepines, antidepressants) where dosage has not been stable for more than 30 days prior to screening.

  7. 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.

  8. Presence of any of the following laboratory abnormalities on screening labs:

    1. Abnormal liver function (AST or ALT more than 2 times the upper limit of normal)
    2. Abnormal renal function (creatinine clearance calculated by the Cockcroft-Gault equation <50mL/min or estimated glomerular filtration rate using the MDRD4 equation or the CKD-EPI equation <45mL/min/1.73m2)
    3. Complete Blood Count out of range on screening labs and physician's judgment that abnormal value is clinically significant.
  9. Uncontrolled hypertension (resting blood pressure >150/90 mmHg).

  10. Orthostatic hypotension and standing systolic BP below 100. Orthostatic hypotension is a reduction of systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of standing.

  11. Already participating in 120 minutes or more of moderate intensity exercise per week.

  12. Serious illness (requiring systemic treatment and/or hospitalization) within the last 4 weeks.

  13. History of any other medical problem or injury that may interfere with ability to exercise.

  14. Condition that precludes the safe performance of routine lumbar puncture, including:

    1. INR > 1.4 or other coagulopathy
    2. Platelet cell count of < 50,000/μL
    3. Infection at the desired lumbar puncture site
    4. Taking anti-coagulant medication within 90 days of baseline (Note: low dose aspirin is permitted)
    5. Suspected non-communicating hydrocephalus or intracranial mass
    6. Prohibitive lumbar spinal disease
  15. Enrollment in another investigational study that includes an intervention; participation in non-interventional studies may be permitted

  16. Receipt of any non-PD investigational product or device or participation in a non-PD drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) before baseline.

  17. History of frequent falls (i.e. falling multiple times per week) or considered high fall risk based on investigator assessment

  18. Lack of access to computer/tablet and WiFi or any other technical challenges that in the opinion of the investigator would prevent participation in the virtually supervised exercise training program.

University of California, San Francisco logoUniversiteit van Californië, San Francisco704 actieve klinische studies om te verkennen
National Institute of Neurological Disorders and Stroke (NINDS) logoNationaal Instituut voor Neurologische Aandoeningen en Beroerte, VS327 actieve klinische studies om te verkennen
Centraal Contactpersoon
Contact: Nijee Luthra, MD, PhD, (415) 502-2960, [email protected]
1 Studielocaties in 1 landen

California

University of California San Francisco, San Francisco, California, 94518, United States
Nijee Luthra, MD, PhD, Contact
Contact, (415) 502-2960, [email protected]
Nijee Luthra, MD, PhD, Hoofdonderzoeker
Recruterend