- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02114580
Brain Plasticity Following Aerobic Exercise in Patient With Mild Cognitive Impairment: Neuroimaging Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Talma Hendler, MD
- Telefonnummer: 97236973953
- E-mail: hendlert@gmail.com
Undersøgelse Kontakt Backup
- Navn: Nir Giladi, MD
- Telefonnummer: 97236974790
- E-mail: nirg@tlvmc.gov.il
Studiesteder
-
-
-
Tel-Aviv, Israel, 64288
- Tel-Aviv Sourasky Medical Center
-
Ledende efterforsker:
- Yulia Lerner, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Only patients at the age of 60-90 who have met criteria for a diagnosis of MCI will be included.
- Participants will be both men and women, and this factor is not specifically addressed.
Exclusion Criteria:
- Patients with any significant medical (i.e. cardiac), neurological (other than MCI) illness will be excluded from the study.
- Medical and neurological illnesses will be ruled out by physical and neurological examinations, reports of the patients' treating physicians and medical records.
- The experiments will be undertaken in compliance with the safety guidelines for MRI research. Based on initial fMRI screening questionnaires, subjects will be excluded if they indicate any risk factor on these questionnaires.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Aerob træning
|
Participants in both the aerobic and stretching groups will carry out their activity routines 3 d/wk for 45 to 60 minutes per session for 4 months. Training will be on "one on one" basis, where each participant will be supervised by an experienced trainer at the participant's home.Aerobic intervention protocol: subjects will practice with stationary bicycle. Exercise intensity will be monitored through wireless HR monitor. Participants will be also monitored for the intensity of their workouts by the Borg's Rating of Perceived Exertion and the "talk" test (a subjective method for estimating of appropriate cardiorespiratory exercise intensity). Stretching exercise protocol: Participants in the stretching control group will carry out a prescribed routine of stretching and balance exercises. |
Aktiv komparator: stretching exercise
|
Participants in both the aerobic and stretching groups will carry out their activity routines 3 d/wk for 45 to 60 minutes per session for 4 months. Training will be on "one on one" basis, where each participant will be supervised by an experienced trainer at the participant's home.Aerobic intervention protocol: subjects will practice with stationary bicycle. Exercise intensity will be monitored through wireless HR monitor. Participants will be also monitored for the intensity of their workouts by the Borg's Rating of Perceived Exertion and the "talk" test (a subjective method for estimating of appropriate cardiorespiratory exercise intensity). Stretching exercise protocol: Participants in the stretching control group will carry out a prescribed routine of stretching and balance exercises. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
functional Magnetic Resonance Imaging
Tidsramme: two weeks prior to intervention
|
two weeks prior to intervention
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Neuropsychological assessment
Tidsramme: two weeks prior to intervention
|
two weeks prior to intervention
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Cardiorespiratory fitness assessment, Serum concentration of BDNF
Tidsramme: two weeks prior to intervention
|
two weeks prior to intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Yulia Lerner, PhD, Functional Brain Center, Wohl Institute for Advanced Imaging, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0051-14-TLV
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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