NCT03808675Befejeződött
Aerobic Exercise in Parkinson's Disease
Long Term Aerobic Exercise to Slow Progression in Parkinson's Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 12.
Rövid összefoglaló (regiszter, angolul)
Parkinson's disease (PD) is an incurable brain illness that afflicts more than one million Americans, including many aging Veterans. PD places an unbearable burden on the individual due to progressive impairment of movement and mental function. As a result, patients lose critical abilities such as driving and can become isolated. Although drugs and surgery help movement problems, their benefits are temporary and may cause side effects. Drugs provide limited and temporary benefit for cognition and do not prevent dementia. Animal and preliminary human studies on aerobic exercise show promising results in helping a broad spectrum of symptoms. However, due to limited and inconsistent research results, the long term effects of aerobic exercise on brain health and clinical features in PD is unknown. The investigators will conduct a clinical trial to test the long term effects of aerobic exercise on the brain tissue, movement, mental functions, and driving in PD. If effective, aerobic exercise can be implemented immediately as a low cost, easily accessible treatment in PD.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 57 (tényleges)
- Első benyújtás
- 2019. jan. 7.
- Kezdés
- 2019. júl. 1.
- Elsődleges befejezés
- 2024. szept. 30.
- Fő szponzor
- VA Office of Research and Development
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT03808675
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 57
- 2019. júl. 1. és az elsődleges befejezés (2024. szept. 30.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálatot írja le, nem a te helyzetedet.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Secondary parkinsonism (e.g., drug induced)
- History of exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to the baseline visit
- Use of investigational drugs within 30 days before screening
- Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to the baseline visit
Más betegség
- Parkinson-plus syndromes
- History of brain surgery for PD such as deep brain stimulation
- Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study
- Presence of dementia per Movement Disorder Society Level I criteria
Életkor
- No confounding acute or unstable medical, psychiatric, orthopedic condition. Subjects who have hypertension, diabetes mellitus, depression, or other common age related illness will be included if their disease under control with stable treatment regimen for at least 30 days.
Egyéb
- Subjects unwilling or unable to give informed consent
- Corrected visual acuity less than 20/50 (due to effect on driving)
- Contraindications to exercise per ACSM criteria for Exercise Testing and Training (Reference: American College of Sports Medicine. Cardiorespiratory Exercise Prescription. In: Ehrman JK, ed. ACSM's Guidelines for Exercise Testing and Prescription.6th ed. Baltimore: Lippincott Williams \& Wilkins, 2010:448-462).
- Clinically significant TBI or PTSD
- Subjects with clinically significant depression as determined by a Beck Depression Inventory (BDI) score greater than 15 at the screening visit
- Contraindication to having a brain MRI
Kiket keres a vizsgálat
- Men or women aged 40 and older with the diagnosis of idiopathic PD per UK Brain Bank criteria
- Hoehn-Yahr Stage I-III, on stable dopaminergic treatment regimen for equal or greater than 4 weeks prior to baseline.
- Aerobic Fitness: VO2max below "very good" fitness levels for their age and gender at baseline cyle ergometry.
- To include subjects who have room to improve their aerobic fitness, the investigators will enroll only those subjects whose VO2max is below "very good" fitness level (about 90% of the population) using age and gender based VO2max norms based review of 62 studies where VO2max was measured directly in healthy adult subjects in the USA, Canada and 7 European countries (Reference: Shvartz, E and Reibold, RC. Aerobic fitness norms for males and females aged 6 to 75 years: a review.
- Aviat Space Environ Med. 1990; 61:3-11).
- Cognitive function: No dementia per Movement Disorder Society Level I criteria (Reference: Dubois, B, Burn, D, Goetz, C, et al. Diagnostic procedures for Parkinson's disease dementia: recommendations from the movement disorder society task force. Mov Disord. 2007; 22:2314-2324).
- Current active drivers with a valid driver's license
- Veteran or non-veteran
Életkor a regiszterben: 40 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Iowa City VA Health Care System, Iowa City, IA Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Iowa City | Egyesült Államok | Ismeretlen állapot |
| University of Iowa Hospitals & Clinics Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Iowa City | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.