- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07759232
Effects of Exercise Snacks on Physical Health and Cognitive Function in Individuals With Intellectual Disabilities
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background:
Adults with intellectual disability commonly maintain sedentary daily routines, resulting in progressive decline in physical fitness and cognitive performance. Traditional long-duration exercise interventions are difficult to implement for this population due to behavioral and cognitive limitations. Exercise snacks, consisting of repeated ultra-short exercise bursts, are easy to carry out and show promising benefits for cognition.
Methods:
A randomized controlled crossover design will be adopted. Twenty-four adults aged 18-35 years with mild to moderate ID will complete three conditions in random sequence: no-exercise control, high-intensity interval training (HIIT), and exercise snacks (ES). A 1-week washout interval separates different interventions.
Intervention protocols:
- Control: maintain habitual daily activities.
- HIIT: one afternoon session, 10 sets of 6-second high-knee exercise with 9 seconds rest.
- ES: morning and afternoon sessions every day; each session contains 5 sets of 6-second high-knee exercise with 9 seconds rest.
Main measurements include prefrontal cortex activation via EEG, cognitive function, stereotyped behaviors, and heart rate variability. Repeated-measures statistical models will be used for data analysis.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Yuping Zhou, master
- Telefonnummer: +86-18811611796
- E-mail: yc57146@um.edu.mo
Studiesteder
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina
- Hangzhou First Social Welfare Institute
-
Kontakt:
- Yuping Zhou, master
- Telefonnummer: +86-18811611796
- E-mail: yc57146@um.edu.mo
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Aged 18-35 years old;
- Clinically diagnosed mild to moderate intellectual disability;
- Able to follow simple verbal instructions and complete exercise protocols;
- No contraindications for moderate physical activity confirmed by medical inquiry;
- Participants or legal guardians provide written informed consent;
- Maintain stable daily routine and do not participate in other structured exercise programs during the trial.
Exclusion Criteria:
- Severe physical disabilities, orthopedic injury or neurological disorders that restrict movement;
- History of cardiovascular disease, uncontrolled hypertension or other exercise contraindications;
- Current psychiatric medication that significantly affects motor or cognitive function;
- Inability to cooperate with EEG and physiological signal collection;
- Pregnancy;
- Participation in other interventional studies within the past 3 months.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Arm 1
Participants maintain their usual daily activities without additional prescribed exercise.
Daily physical activity will be recorded throughout the intervention period.
|
|
|
Eksperimentel: Arm 2(Exercise Snacks)
Twice-daily short-bout exercise snacks.
Each session includes 5 sets of 6-second high-knee exercise with 9 seconds rest between sets.
|
Twice-daily short-bout exercise snacks.
Each session includes 5 sets of 6-second high-knee exercise with 9 seconds rest between sets.
|
|
Eksperimentel: Arm 3(High-Intensity Interval Training )
One intervention session scheduled in the afternoon.
The protocol consists of 10 sets of 6-second high-knee exercise, separated by 9 seconds of rest between sets.
|
Acute high-intensity interval training protocol: 10 × 6 s high-knee exercise with 9 s rest between sets, completed in a single afternoon session.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in cognitive function assessed by cognitive test battery
Tidsramme: Baseline and immediately after the acute intervention
|
Changes in cognitive performance measured after each intervention condition, including attention and executive function.
|
Baseline and immediately after the acute intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Prefrontal cortex activation measured by electroencephalography (EEG)
Tidsramme: Baseline and immediately after the acute intervention
|
Changes in prefrontal cortical brain activity indexed by EEG power spectrum during cognitive tasks.
|
Baseline and immediately after the acute intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Zhaowei Kong, PhD, University of Macau
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Psykiske lidelser
- Neuroadfærdsmæssige manifestationer
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Tegn og symptomer
- Neuroudviklingsforstyrrelser
- Intellektuel handicap
- Motorisk aktivitet
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Fysisk konditionering, menneske
- Øvelse
- Intervaltræning med høj intensitet
Andre undersøgelses-id-numre
- BSE-1553-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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