NCT07194460Toborzás még nem indult
Combined Exercise and PMS: Impact on Biopsychosocial Function in Older Adults With Schizophrenia
Effects of Combined Exercise and Peripheral Magnetic Stimulation on Biopsychosocial Functional Impairments in Older Adults With Schizophrenia
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 26. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
This project consists of two randomized parallel - group experiments targeting older adults with schizophrenia, aiming to evaluate the therapeutic effect of Peripheral Magnetic Stimulation (PMS). Experiment 1 (Efficacy of PMS): During a 4 - week intervention period, participants are randomly assigned to receive active PMS or sham PMS. The primary objective is to determine whether PMS can reduce the clinical symptom burden and improve biopsychosocial functioning compared with sham stimulation through electroencephalogram (EEG) signal acquisition and evaluation. Secondary objectives include the effects on cognition, mood, sleep, and health - related quality of life, as well as safety and tolerability (adverse events monitoring). Experiment 2 (Comparison of Intervention Effects): The subjects are randomly divided into three groups: exercise combined with PMS group, PMS alone group, and exercise alone group. Each group is arranged by relevant professionals to carry out the corresponding intervention for 4 weeks. The main purpose is to examine the differences in the effects of the three intervention methods (exercise combined with PMS, PMS alone, and exercise alone) in improving patients' conditions, including the impact on exercise - related physical performance, functional mobility, etc. Secondary objectives include the impact on overall function and quality of life, along with safety monitoring. In both experiments, outcome indicators are measured from baseline to post - intervention (and, where feasible, short - term follow - up) by assessors who are blinded to group allocation using appropriate tools. It is hypothesized that in Experiment 1, PMS will be superior to sham stimulation; in Experiment 2, the effect of exercise combined with PMS in improving patients' motor and related functions will be better than that of PMS alone or exercise alone, which supports PMS as a scalable auxiliary means for the rehabilitation of this population.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tervezett)
- Első benyújtás
- 2025. szept. 5.
- Kezdés
- 2025. szept. 28.
- Elsődleges befejezés
- 2025. dec. 1.
- Fő szponzor
- Yuntong Zhang
- Betegségek
- Skizofrénia
- NCT-szám
- NCT07194460
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 40
- 2025. szept. 28. és az elsődleges befejezés (2025. dec. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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A regiszterben nem jelölt feltételek
- # Eligibility Criteria
- Inclusion Criteria:
- Participants must be aged ≥60 years.
- Diagnosis of schizophrenia based on the International Classification of Diseases - 10th Edition (ICD-10) or Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5).
- Diagnosis must be made for ≥6 months, with clinical manifestations of schizophrenia (e.g., hallucinations, delusions, thought disorder, etc.).
- No history of severe acute psychiatric episodes or hospitalizations within the last 3 months prior to enrollment.
- Symptoms must be controllable, with no reliance on acute psychiatric intervention.
- Participants must be able to understand the study's purpose and procedures and provide written informed consent. If the participant is unable to provide full informed consent (e.g., due to severe cognitive impairment), informed consent must be obtained from a legal guardian.
- Exclusion Criteria:
- Schizoaffective disorder or bipolar disorder with psychosis.
- Elderly individuals with multiple chronic diseases but who still maintain good functional status and quality of life.
- Presence of severe cardiovascular diseases, liver or kidney dysfunction, cerebrovascular diseases, or other physical conditions that may affect treatment.
- Patients with contraindications to peripheral magnetic stimulation (PMS) treatment or EEG.
Életkor a regiszterben: 60 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Kapcsolódó publikációk
- Peripheral magnetic stimulation effects on brain activity in older adults with schizophrenia - a randomized controlled pilot study.Front Psychiatry · 2026 · PMID 42630304
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.