Effects of an Exercise Snacking Intervention on Cognitive Function in Patients With Mild Cognitive Impairment: A Nationwide Multicenter Randomized Controlled Trial (ES-MCI)
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Xiaoli Wang, PhD
- Telefonnummer: +8619526438101
- E-Mail: wang18249277812@163.com
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Aged 51 to 80 years, inclusive.
Meet the NIA-AA core clinical criteria for probable amnestic mild cognitive impairment (aMCI), including all of the following:
- A self-reported and/or informant-reported history of progressive memory decline lasting for more than 6 months, confirmed by a study neurologist;
- Objective impairment in one or two cognitive domains on standardized neuropsychological testing, with memory impairment required;
- Montreal Cognitive Assessment (MoCA) score of 18-26;
- Cognitive impairment does not result in significant functional dependence, with instrumental activities of daily living (IADL) remaining normal or only mildly impaired;
- Does not meet diagnostic criteria for any type of dementia.
- Able to independently use a smartphone and complete online check-ins, questionnaires, and other digital assessment tasks.
- Able to walk independently without assistance.
- No absolute contraindications to exercise, as determined by the Physical Activity Readiness Questionnaire or by a study physician when exercise-related risks are considered manageable.
- Willing and able to provide written informed consent.
- A primary caregiver, if applicable, is informed of and supportive of study participation.
- Willing and able to comply with the 24-month follow-up schedule and complete all study assessments and intervention tasks.
- Participants taking cognition-enhancing or other cognition-active medications may be included, provided that the medication dose has remained stable for at least 1 month before screening.
Exclusion Criteria:
Cognitive impairment attributable to other causes, including:
- Meeting clinical diagnostic criteria for Alzheimer's disease or another type of dementia;
- Cognitive impairment primarily attributable to another clearly identified condition, including neurodegenerative diseases (e.g., Parkinson's disease, Huntington's disease, progressive supranuclear palsy, or multiple sclerosis), severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, or major depressive episode with psychotic features), or systemic diseases (e.g., uncontrolled thyroid dysfunction or vitamin B12 deficiency).
Severe or unstable medical conditions, including any of the following:
- Acute cardiovascular or cerebrovascular event within the previous 6 months, including myocardial infarction, unstable angina, stroke, or transient ischemic attack;
- New York Heart Association (NYHA) class III or IV heart failure;
- Poorly controlled hypertension, defined as resting blood pressure ≥180/110 mmHg;
- Poorly controlled diabetes mellitus, defined as HbA1c >9.0%;
- Severe musculoskeletal disease resulting in inability to walk continuously for more than 100 meters;
- Severe respiratory disease;
- Malignancy with an estimated life expectancy of less than 2 years.
- Severe visual or hearing impairment that prevents the participant from adequately seeing assessment materials or hearing instructions despite the use of conventional corrective devices, such as glasses or hearing aids.
High risk of falls, defined by any of the following:
- Two or more unprovoked falls during the previous year;
- A score of 0 on the balance component of the Short Physical Performance Battery (SPPB), indicating inability to stand with the feet together;
- Requirement for routine use of a walking aid or wheelchair.
- Current participation in another clinical trial that may affect cognitive function or physical activity.
- Planning to relocate outside the study area for more than 3 months during the next 24 months.
- Any other condition that, in the investigator's judgment, may compromise participant safety, data integrity, or adherence to the study protocol.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: Baduanjin Exercise Snacking Group
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education.
The intervention consists of brief, repeated bouts of Baduanjin exercise performed multiple times throughout the day.
Standardized instructional videos and digital support will be provided to facilitate intervention delivery and adherence.
|
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education.
The intervention consists of brief bouts of Baduanjin exercise distributed throughout the day and is adapted to the cognitive and physical characteristics of older adults with mild cognitive impairment.
Standardized instructional videos and digital support will be used to guide exercise performance and record intervention adherence.
Exercise intensity and safety will be monitored throughout the intervention period.
|
|
Aktiver Komparator: Control Group
Participants will receive routine health education during the 24-week intervention period and will not receive the prescribed Baduanjin-based exercise snacking intervention.
|
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education.
The intervention consists of brief bouts of Baduanjin exercise distributed throughout the day and is adapted to the cognitive and physical characteristics of older adults with mild cognitive impairment.
Standardized instructional videos and digital support will be used to guide exercise performance and record intervention adherence.
Exercise intensity and safety will be monitored throughout the intervention period.
|
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 24
Zeitfenster: Baseline and Week 24
|
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point cognitive screening instrument covering multiple cognitive domains.
Scores range from 0 to 30, with higher scores indicating better cognitive function.
The primary outcome is the change in MoCA score from baseline to Week 24.
|
Baseline and Week 24
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 12
Zeitfenster: Baseline and Week 12
|
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point cognitive screening instrument covering multiple cognitive domains.
Scores range from 0 to 30, with higher scores indicating better cognitive function.
The outcome is the change in MoCA score from baseline to Week 12.
|
Baseline and Week 12
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Xiaoli Wang, PhD, Peking University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- IRB00001052-26132
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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