Immersive Nature-Based Wellbeing Program in Older Adults With Cognitive Impairment (COGNITIO)
Cognitio Avançada: Immersive Nature-Based Wellbeing Program for Older Adults With Cognitive Impairment: A Quasi-Experimental Pre-Post Study
This study aims to evaluate an immersive virtual reality program designed to support cognitive and emotional well-being in older adults with mild to moderate cognitive impairment. The program uses nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques. The goal is to determine whether immersive virtual reality can be a safe and effective tool to improve well-being and support active and healthy aging.
The study will be conducted in two phases. In the first phase, virtual environments will be tested in healthy participants using behavioral and physiological measures. In the second phase, 200 older adults with cognitive impairment from day care centers and residential facilities will participate in a group-based immersive virtual reality intervention consisting of 10 sessions.
Researchers will assess changes in cognitive function, emotional wellbeing, daily functioning, and quality of life before and after the intervention.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
This study evaluates the effectiveness of an immersive virtual reality program based on nature environments to improve cognitive function, emotional well-being, functional ability, and quality of life in older adults with mild to moderate cognitive impairment.
Cognitive impairment is common in older adults and can negatively affect independence, emotional well-being, and quality of life. Non-pharmacological interventions using emerging technologies, such as immersive virtual reality, offer new opportunities to support cognitive and emotional health. Nature-based virtual environments may help reduce stress, improve mood, and increase engagement, even in individuals with limited mobility or access to natural settings.
The study takes place across services affiliated with Suara Cooperativa. In Phase 1, researchers test and validate immersive virtual environments in healthy participants. Participants attend individual sessions where they view nature-based virtual scenarios. Researchers collect behavioral, subjective, and physiological data, including electroencephalography, heart rate, electrodermal activity, and respiration, to assess safety, usability, and emotional responses to the virtual environments.
In Phase 2, researchers conduct a quasi-experimental pre-post study without a control group. The study includes 200 participants (100 with mild cognitive impairment and 100 with moderate cognitive impairment) recruited from day care centers and residential facilities managed by Suara Cooperativa.
Participants take part in a structured group-based intervention consisting of 10 immersive virtual reality sessions. The program combines exposure to nature-based virtual environments with mindfulness practices, cognitive stimulation activities, and breathing techniques to promote emotional regulation and cognitive engagement. The intervention is accessible, engaging, and adapted to the needs of older adults with cognitive impairment.
Primary outcome measures include cognitive function, emotional well-being, functional capacity in activities of daily living, and quality of life. Researchers also assess participant engagement and acceptability of the intervention as secondary measures.
Researchers analyze data using descriptive and inferential statistical methods to assess changes between pre- and post-intervention measures. They also evaluate adherence to the intervention and participant satisfaction.
This study aims to generate evidence on the potential of immersive virtual reality as an innovative, safe, and accessible non-pharmacological intervention to support cognitive health, emotional well-being, and autonomy in older adults, contributing to active and healthy aging.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Maite Garolera, PhD
- Puhelinnumero: 1558 +34937310007
- Sähköposti: mgarolera@cst.cat
Opiskelupaikat
-
-
Barcelona
-
Terrassa, Barcelona, Espanja, 08227
- Rekrytointi
- Consorci Sanitari de Terrassa
-
Ottaa yhteyttä:
- Maite Garolera, PhD
- Puhelinnumero: 1758 +34937310007
- Sähköposti: mgarolera@cst.cat
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Age ≥ 65 years
- Diagnosis of mild or moderate cognitive impairment
- Ability to understand study procedures and follow instructions
- Ability to provide informed consent (or consent provided by a legal representative)
- Attendance at participating day care centers or residential facilities (Phase 2)
- For Phase 1: healthy adults without cognitive impairment
Exclusion Criteria:
- Severe cognitive impairment or diagnosis of advanced dementia
- Severe visual, auditory, or motor impairments that prevent use of virtual reality
- Neurological or psychiatric conditions that may interfere with participation
- History of epilepsy or conditions contraindicating virtual reality exposure
- Severe behavioral disturbances or agitation
- Participation in other clinical studies that may interfere with results
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Immersive virtual reality intervention
Participants receive a group-based immersive virtual reality intervention consisting of 10 sessions using nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques.
|
Participants receive an immersive virtual reality intervention using nature-based environments.
The program consists of 10 group sessions that combine mindfulness, cognitive stimulation, and breathing techniques to promote cognitive and emotional well-being.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in cognitive function (verbal fluency and Digit Span tests)
Aikaikkuna: Baseline (pre-intervention) and immediately post-intervention (1 week)
|
Cognitive function is assessed using verbal fluency tasks and Digit Span tests (forward and backward).
Verbal fluency evaluates language and executive function by measuring the number of words generated under specific conditions.
Digit Span forward assesses attention, while Digit Span backward assesses working memory.
Higher scores indicate better cognitive performance.
|
Baseline (pre-intervention) and immediately post-intervention (1 week)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in anxiety symptoms (Generalized Anxiety Disorder 7-item scale [GAD-7])
Aikaikkuna: Baseline (pre-intervention) and immediately post-intervention (1 week)
|
Anxiety symptoms are assessed using the GAD-7 questionnaire, a validated self-report scale measuring severity of generalized anxiety symptoms.
Higher scores indicate greater anxiety.
|
Baseline (pre-intervention) and immediately post-intervention (1 week)
|
|
Short-form Yesavage Geriatric Depression Scale (GDS-SF)
Aikaikkuna: Baseline (pre-intervention) and immediately post-intervention (1 week)
|
Depressive symptoms are assessed using the GDS-SF, a validated screening tool for depression in older adults.
Higher scores indicate greater depressive symptomatology.
|
Baseline (pre-intervention) and immediately post-intervention (1 week)
|
|
Change in positive and negative affect (Positive and Negative Affect Schedule-10 [PANAS-10])
Aikaikkuna: Baseline (pre-intervention) and immediately post-intervention (1 week)
|
Affective state is assessed using the PANAS-10, which measures positive and negative affect.
Higher scores reflect higher levels of the corresponding affect.
|
Baseline (pre-intervention) and immediately post-intervention (1 week)
|
|
Change in loneliness (UCLA Loneliness Scale, UCLA-10)
Aikaikkuna: Baseline (pre-intervention) and immediately post-intervention (1 week)
|
Loneliness is assessed using the UCLA-10 scale, a validated self-report measure of perceived social isolation.
Higher scores indicate greater loneliness.
|
Baseline (pre-intervention) and immediately post-intervention (1 week)
|
|
Change in quality of life (EuroQol 5-Dimension 5-Level questionnaire [EQ-5D-5L])
Aikaikkuna: Baseline (pre-intervention) and immediately post-intervention (1 week)
|
Quality of life is assessed using the EuroQol-5D-5L questionnaire, which evaluates health status across five dimensions.
Higher index values indicate better perceived health-related quality of life.
|
Baseline (pre-intervention) and immediately post-intervention (1 week)
|
|
Change in functional ability (Bayer Activities of Daily Living Scale [BAYER-ADL])
Aikaikkuna: Baseline (pre-intervention) and immediately post-intervention (1 week)
|
Functional ability is assessed using the Bayer Activities of Daily Living Scale, which measures impairments in instrumental activities of daily living.
Higher scores indicate greater functional impairment.
|
Baseline (pre-intervention) and immediately post-intervention (1 week)
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Perceived immersion during virtual reality sessions (Self-Assessment Manikin, SAM)
Aikaikkuna: At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.
|
Immersion is assessed using the Self-Assessment Manikin (SAM), a non-verbal pictorial tool that captures participants' subjective experience during exposure to immersive virtual environments.
|
At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.
|
|
Participant satisfaction with immersive virtual reality sessions
Aikaikkuna: At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.
|
Satisfaction is assessed using an ad hoc questionnaire evaluating participants' experience, acceptability, and perceived usefulness of the intervention.
|
At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.
|
|
Intervention adherence based on session attendance and completion rates
Aikaikkuna: At the end of each intervention day: Day 1 (after session 4), Day 2 (after session 7), and Day 3 (after session 10).
|
Adherence is measured by attendance rate and completion of the scheduled sessions.
|
At the end of each intervention day: Day 1 (after session 4), Day 2 (after session 7), and Day 3 (after session 10).
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- DDS027/24/000611
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .