- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07759232
Effects of Exercise Snacks on Physical Health and Cognitive Function in Individuals With Intellectual Disabilities
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Yuping Zhou, master
- Telefonnummer: +86-18811611796
- E-post: yc57146@um.edu.mo
Studieorter
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina
- Hangzhou First Social Welfare Institute
-
Kontakt:
- Yuping Zhou, master
- Telefonnummer: +86-18811611796
- E-post: yc57146@um.edu.mo
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Arm 1
Participants maintain their usual daily activities without additional prescribed exercise.
Daily physical activity will be recorded throughout the intervention period.
|
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in cognitive function assessed by cognitive test battery
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Prefrontal cortex activation measured by electroencephalography (EEG)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Zhaowei Kong, PhD, University of Macau
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Sjukdomar i nervsystemet
- Mentala störningar
- Neurobehavioral manifestationer
- Patologiska tillstånd, tecken och symtom
- Beteende
- Tecken och symtom
- Neuropsykiatriska funktionsnedsättningar
- Intellektuell funktionsnedsättning
- Motorisk aktivitet
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Fysisk konditionering, mänsklig
- Utöva
- Högintensiv intervallträning
Andra studie-ID-nummer
- BSE-1553-2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
Läkemedels- och apparatinformation, studiedokument
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