Clinical trial NCT06939621: Trajectories for Active and Healthy Aging
Official title: Trajectories for Active and Healthy Aging (Behavioural and Psychological Determinants)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Older Adults (65 Years and Older)
Virtual Reality
Physical Activity
Keywords: Older adult
Virtual Reality
Physical Activity
Self-Determination Theory
Motivation
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: University of Rome Tor Vergata
First posted: 2025-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A randomized controlled trial, including 60 older adults, were divided into four groups each involved in a 4 week intervention under 4 different conditions.
Primary purpose: PREVENTION

Brief summary: The objective of the present study is to identify which psychological and motivational factors can help foster Virtual Reality (VR)-based interventions. Specifically, the main question is:

- Does the combination of VR-based interventions and motivational messages grounded in Self-Determination Theory (SDT) impact older adults' motivation for physical activity and their physiological indicators related to exercise? Older adults will participate to a 4 week intervention where they have ti engage in a physical activity program under different conditions: with and without VR, with and with out motivational messages.


Eligibility criteria: Inclusion Criteria:

* over 65 years old
* to be fluent in Italian
* to have an informant familiar with their daily functioning
* needed to be available for the full duration of the study
* to be free from a history of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder), nervous system infections or disorders (e.g., epilepsy, brain tumor, large-vessel stroke, major head trauma), or current metabolic or systemic conditions (e.g., B12 deficiency, renal failure, cancer)

Exclusion Criteria:

* severe sensory or motor impairments that would hinder task performance (e.g., blindness, total hearing loss, severe upper extremity deformities or paralysis)
* susceptibility to motion sickness (as confirmed by the Motion Sickness Susceptibility Questionnaire)
* intellectual disability (as assessed by the MMSE).

Primary outcomes:
measure: Physical activity
timeFrame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
measure: Basic Psychological Needs
timeFrame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
measure: Motivation for physical activity
timeFrame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
measure: General Physical Health
timeFrame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
measure: General Mental Health
timeFrame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
measure: Physiological measures of Physical Activity: Hearth rate variability
timeFrame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
measure: Physiological measures of Physical Activity: galvanic conductance
timeFrame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
measure: Physical activity
timeFrame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
measure: Basic Psychological Needs
timeFrame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
measure: Motivation for physical activity
timeFrame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
measure: General Physical Health
timeFrame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
measure: General Mental Health
timeFrame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
measure: Physiological measures of Physical Activity: hearth rate variability
timeFrame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
measure: Physiological measures of Physical Activity: galvanic conductance
timeFrame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
measure: Physical activity
timeFrame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
measure: Basic Psychological Needs
timeFrame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
measure: Motivation for physical activity
timeFrame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
measure: General Physical Health
timeFrame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
measure: General Mental Health
timeFrame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
measure: Physiological measures of Physical Activity: hearth rate variability
timeFrame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
measure: Physiological measures of Physical Activity: galvanic conductance
timeFrame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
measure: Physical activity
timeFrame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
measure: Basic Psychological Needs
timeFrame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
measure: Motivation for physical activity
timeFrame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
measure: General Physical Health
timeFrame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
measure: General Mental Health
timeFrame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
measure: Physiological measures of Physical Activity: galvanic conductance
timeFrame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
measure: Physiological measures of Physical Activity: hearth rate variability
timeFrame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Secondary outcomes:
measure: Well-being
timeFrame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
measure: Self-Efficacy for exercise
timeFrame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
measure: Virtual reality experience: physical symptoms
timeFrame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
measure: Virtual reality experience: eye-related symptoms
timeFrame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
measure: Well-being
timeFrame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
measure: Self-Efficacy for exercise
timeFrame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
measure: Virtual reality experience: physical symptoms
timeFrame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
measure: Virtual reality experience: eye-related symptoms
timeFrame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
measure: Well-being
timeFrame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
measure: Self-Efficacy for exercise
timeFrame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
measure: Virtual reality experience: physical symptoms
timeFrame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
measure: Virtual reality experience: eye-related symptoms
timeFrame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
measure: Well-being
timeFrame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
measure: Self-Efficacy for exercise
timeFrame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
measure: Virtual reality experience: physical symptoms
timeFrame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
measure: Virtual reality experience: eye-related symptoms
timeFrame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome
Study officials:
affiliation: University of Roma La Sapienza
name: Fabio Lucidi
role: PRINCIPAL_INVESTIGATOR
References: