- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07644156
The Impact of Physical Exercise on Working Memory in Elderly People With Mild Cognitive Impairment
Age-related cognitive decline has evolved into a global public health concern, with deteriorated executive function serving as its predominant manifestation. Working memory, a vital component of executive function, refers to a capacity-limited system that temporarily stores and manipulates information during sophisticated cognitive processes such as language comprehension, learning, and reasoning. It constitutes the core of general cognitive functioning and underpins daily functional performance.
The prefrontal cortex is a pivotal brain region subserving working memory and is highly vulnerable to pathological aging. Advancing age triggers prefrontal cortical atrophy and reduced synaptic density, which in turn induces working memory impairment. Consistently, existing evidence identifies working memory as one of the cognitive domains most susceptible to aging and among the first functions compromised in neurodegenerative disorders including Alzheimer's disease.
As a non-pharmacological strategy, physical exercise intervention has been validated to exert favorable effects on cognitive improvement. Both aerobic and resistance training effectively ameliorate working memory; nevertheless, head-to-head evidence comparing their intervention efficacy among older adults with mild cognitive impairment (MCI) remains scarce, particularly regarding underlying neurophysiological mechanisms. This study aims to explore the impacts of physical training on working memory in older women living with MCI.
Accordingly, the present study aimed to investigate the effects of both a single exercise session and a 12-week intervention on upper- and lower-limb muscle strength and working memory in older women with MCI. In addition, we sought to examine the statistical associations between changes in muscle strength and working memory, with particular attention to the potential mediating role of muscle strength changes. Previous studies have suggested that interventions targeting muscle strength and physical function in middle-aged and older adults are commonly implemented over 12-52 weeks at a frequency of two to three sessions per week, whereas exercise interventions targeting cognitive function in older adults are often conducted over 12-24 weeks at a similar frequency. Based on this evidence, together with feasibility considerations in residential care settings, we adopted a 12-week intervention delivered three times per week. This study contributes to the literature by integrating both acute and chronic effects within a single randomized controlled framework and by exploring the muscle strength-cognition pathway as a potential explanatory mechanism for exercise-related cognitive benefits.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200438
- Shanghai University of Sport
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Age >= 65years;
- Free from major organic diseases or cardiovascular diseases, and showing no contraindications to exercise according to the pre-exercise screening questionnaire developed by the American Heart Association (AHA) and the American College of Sports Medicine (ACSM);
- Able to communicate effectively and, subject to their condition, cooperate in completing questionnaires and tests;
- Willing to participate in this study and sign an informed consent form.
Exclusion Criteria:
- Suffering from severe cognitive impairment, mental illness or other neurodegenerative diseases (such as Parkinson's dementia, stroke, frontotemporal degeneration, vascular dementia, Lewy body dementia, etc.), where the condition impairs communication or the ability to follow experimental instructions;
- Suffering from severe physical injuries that prevent prolonged standing, standing or participation in physical activities;
- Currently taking, or having taken in the recent past, psychotropic drugs or medications that affect physical mobility;
- Plans for surgical treatment in the near future (within the next 6 months);
- Unwillingness to participate in or withdrawal from this study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Resistance band exercise intervention
Perform resistance training using Thera-Band resistance bands.
Warm up for 5 minutes; proceed to the main workout, which consists of 10 exercises.
Perform 2 sets of each exercise, with 8 to 12 repetitions per set, resting for 1 minute between sets.
The session lasts approximately 25 to 30 minutes; finish with a cool-down and stretching.
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Perform resistance training using Thera-Band resistance bands.
Warm up for 5 minutes; proceed to the main workout, which consists of 10 exercises.
Perform 2 sets of each exercise, with 8 to 12 repetitions per set, resting for 1 minute between sets.
The session lasts approximately 25 to 30 minutes; finish with a cool-down and stretching.
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Experimental: Brisk walking intervention
Warm up for 5 minutes, then walk briskly for 25 to 30 minutes once you reach your target heart rate for moderate intensity (65%-75% of HRmax); finish with a cool-down.
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Warm up for 5 minutes, then walk briskly for 25 to 30 minutes once you reach your target heart rate for moderate intensity (65%-75% of HRmax); finish with a cool-down.
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Experimental: Eight-Section brocade exercise intervention
A 5-minute warm-up and stretching session; followed by two sets of the 'Eight Brocades' fitness qigong routine compiled by the General Administration of Sport, lasting approximately 24 minutes in total; and finally, a cool-down and relaxation session.
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A 5-minute warm-up and stretching session; followed by two sets of the 'Eight Brocades' fitness qigong routine compiled by the General Administration of Sport, lasting approximately 24 minutes in total; and finally, a cool-down and relaxation session.
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Placebo-Komparator: Control group
Maintain current routine.
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Maintain current routine.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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The N-back working memory task
Zeitfenster: This study runs from 4 March 2026 to 31 August 2026. Each participant receives assessments within one week at baseline and one week after intervention.
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Implemented using E-Prime 3.0 software, with Arabic numerals as stimuli.
Participants were required to respond according to the task instructions, recording reaction time (RT)and accuracy (ACC).
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This study runs from 4 March 2026 to 31 August 2026. Each participant receives assessments within one week at baseline and one week after intervention.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Montreal Cognitive Assessment Scale
Zeitfenster: This study runs from 4 March 2026 to 31 August 2026. Each participant receives assessments within one week at baseline and one week after intervention.
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Global cognitive function was assessed using the Montreal Cognitive Assessment (MoCA), which includes 11 items covering attention, executive function, memory, language, visuospatial ability, abstraction, calculation, and orientation.
The total score ranges from 0 to 30, with higher scores indicating better cognitive function.
One point was added for participants with fewer than 12 years of education.
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This study runs from 4 March 2026 to 31 August 2026. Each participant receives assessments within one week at baseline and one week after intervention.
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Xing Wang, Shanghai University of Sport
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 102772025RT275 (Registrierungskennung: Physical Exercise on Working Memory in Old People with MCI)
- 22BTY076 (Andere Zuschuss-/Finanzierungsnummer: National Social Science Fund of China)
- 11DZ2261100 (Andere Zuschuss-/Finanzierungsnummer: Shanghai Science and Technology Commission)
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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