Trajectories for Active and Healthy Aging

NCT06939621 | Completed

• 1 other identifier: CERT_1908372DCC2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Older Adults (65 Years and Older); Virtual Reality; Physical Activity

Keywords

Older adult; Virtual Reality; Physical Activity; Self-Determination Theory; Motivation

Outcome Measures

Primary Outcomes (28)

• Physical activity

  The Godin-Shephard Leisure-Time Physical Activity Questionnaire. The GSLTPAQ comprises three items, each representing a different intensity of exercise: strenuous (e.g., running), moderate (e.g., fast walking), and mild (e.g., yoga). Participants report the number of times per week they engage in 20 minutes of strenuous, moderate, and mild exercise during their free time. To calculate the Leisure Score Index (LSI), the weekly duration of each activity type is multiplied by its respective Metabolic Equivalent Task (MET) value: 3 for mild, 5 for moderate, and 9 for strenuous. Larger values indicate higher levels of engagement in physical activity.

  Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.

• Basic Psychological Needs

  The Psychological Need Satisfaction in Exercise Scale (PNSE) was used to assess SDT basic psychological needs. The PNSE consists of 18 items, rated on a 6-point Likert scale (from 1 ="false" to 6 = "true"). Larger values indicate higher satisfaction of basic psychological needs.

  Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.

• Motivation for physical activity

  The Behavioural Regulations in Exercise Questionnaire (BREQ-3) was use to assess motivation for physical activity as poised by the Self-Determination Theory. It consists of 18 items rated on a five-point Likert scale, ranging from 0 ("not true for me") to 4 ("very true for me").

  Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.

• General Physical Health

  Physical health was assessed using the 12-Item Short Form Survey (SF-12), which comprises 12 items. Raw scores are transformed into T-scores, with higher scores indicating better physical health.

  Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.

• General Mental Health

  Mental health was assessed using the 12-Item Short Form Survey (SF-12), which comprises 12 items. Raw scores are transformed into T-scores, with higher scores indicating better mental health.

  Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.

• Physiological measures of Physical Activity: Hearth rate variability

  Hearth rate variability was measure through the smartwatch EMPATICA EmbracePlus.

  Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.

• Physiological measures of Physical Activity: galvanic conductance

  Galvanic conductance was measure through the smartwatch EMPATICA EmbracePlus.

  Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.

• Physical activity

  The Godin-Shephard Leisure-Time Physical Activity Questionnaire. The GSLTPAQ comprises three items, each representing a different intensity of exercise: strenuous (e.g., running), moderate (e.g., fast walking), and mild (e.g., yoga). Participants report the number of times per week they engage in 20 minutes of strenuous, moderate, and mild exercise during their free time. To calculate the Leisure Score Index (LSI), the weekly duration of each activity type is multiplied by its respective Metabolic Equivalent Task (MET) value: 3 for mild, 5 for moderate, and 9 for strenuous. Larger values indicate higher levels of engagement in physical activity.

  Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.

• Basic Psychological Needs

  The Psychological Need Satisfaction in Exercise Scale (PNSE) was used to assess SDT basic psychological needs. The PNSE consists of 18 items, rated on a 6-point Likert scale (from 1 ="false" to 6 = "true"). Larger values indicate higher satisfaction of basic psychological needs.

  Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.

• Motivation for physical activity

  The Behavioural Regulations in Exercise Questionnaire (BREQ-3) was use to assess motivation for physical activity as poised by the Self-Determination Theory. It consists of 18 items rated on a five-point Likert scale, ranging from 0 ("not true for me") to 4 ("very true for me").

  Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.

• General Physical Health

  Physical health was assessed using the 12-Item Short Form Survey (SF-12), which comprises 12 items. Raw scores are transformed into T-scores, with higher scores indicating better physical health.

  Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.

• General Mental Health

  Mental health was assessed using the 12-Item Short Form Survey (SF-12), which comprises 12 items. Raw scores are transformed into T-scores, with higher scores indicating better mental health.

  Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.

• Physiological measures of Physical Activity: hearth rate variability

  Hearth rate variability was measure through the smartwatch EMPATICA EmbracePlus.

  Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.

• Physiological measures of Physical Activity: galvanic conductance

  Galvanic conductance was measure through the smartwatch EMPATICA EmbracePlus.

  Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.

• Physical activity

  The Godin-Shephard Leisure-Time Physical Activity Questionnaire. The GSLTPAQ comprises three items, each representing a different intensity of exercise: strenuous (e.g., running), moderate (e.g., fast walking), and mild (e.g., yoga). Participants report the number of times per week they engage in 20 minutes of strenuous, moderate, and mild exercise during their free time. To calculate the Leisure Score Index (LSI), the weekly duration of each activity type is multiplied by its respective Metabolic Equivalent Task (MET) value: 3 for mild, 5 for moderate, and 9 for strenuous. Larger values indicate higher levels of engagement in physical activity.

  Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.

• Basic Psychological Needs

  The Psychological Need Satisfaction in Exercise Scale (PNSE) was used to assess SDT basic psychological needs. The PNSE consists of 18 items, rated on a 6-point Likert scale (from 1 ="false" to 6 = "true"). Larger values indicate higher satisfaction of basic psychological needs.

  Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.

• Motivation for physical activity

  The Behavioural Regulations in Exercise Questionnaire (BREQ-3) was use to assess motivation for physical activity as poised by the Self-Determination Theory. It consists of 18 items rated on a five-point Likert scale, ranging from 0 ("not true for me") to 4 ("very true for me").

  Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.

• General Physical Health

  Physical health was assessed using the 12-Item Short Form Survey (SF-12), which comprises 12 items. Raw scores are transformed into T-scores, with higher scores indicating better physical health.

  Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.

• General Mental Health

  Mental health was assessed using the 12-Item Short Form Survey (SF-12), which comprises 12 items. Raw scores are transformed into T-scores, with higher scores indicating better mental health.

  Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.

• Physiological measures of Physical Activity: hearth rate variability

  Hearth rate variability was measure through the smartwatch EMPATICA EmbracePlus.

  Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.

• Physiological measures of Physical Activity: galvanic conductance

  Galvanic conductance was measure through the smartwatch EMPATICA EmbracePlus.

  Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.

• Physical activity

  The Godin-Shephard Leisure-Time Physical Activity Questionnaire. The GSLTPAQ comprises three items, each representing a different intensity of exercise: strenuous (e.g., running), moderate (e.g., fast walking), and mild (e.g., yoga). Participants report the number of times per week they engage in 20 minutes of strenuous, moderate, and mild exercise during their free time. To calculate the Leisure Score Index (LSI), the weekly duration of each activity type is multiplied by its respective Metabolic Equivalent Task (MET) value: 3 for mild, 5 for moderate, and 9 for strenuous. Larger values indicate higher levels of engagement in physical activity.

  Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.

• Basic Psychological Needs

  The Psychological Need Satisfaction in Exercise Scale (PNSE) was used to assess SDT basic psychological needs. The PNSE consists of 18 items, rated on a 6-point Likert scale (from 1 ="false" to 6 = "true"). Larger values indicate higher satisfaction of basic psychological needs.

  Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.

• Motivation for physical activity

  The Behavioural Regulations in Exercise Questionnaire (BREQ-3) was use to assess motivation for physical activity as poised by the Self-Determination Theory. It consists of 18 items rated on a five-point Likert scale, ranging from 0 ("not true for me") to 4 ("very true for me").

  Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.

• General Physical Health

  Physical health was assessed using the 12-Item Short Form Survey (SF-12), which comprises 12 items. Raw scores are transformed into T-scores, with higher scores indicating better physical health.

  Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.

• General Mental Health

  Mental health was assessed using the 12-Item Short Form Survey (SF-12), which comprises 12 items. Raw scores are transformed into T-scores, with higher scores indicating better mental health.

  Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.

• Physiological measures of Physical Activity: galvanic conductance

  Galvanic conductance was measure through the smartwatch EMPATICA EmbracePlus.

  Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.

• Physiological measures of Physical Activity: hearth rate variability

  Hearth rate variability was measure through the smartwatch EMPATICA EmbracePlus.

  Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.

Secondary Outcomes (16)

• Well-being

  Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.

• Self-Efficacy for exercise

  Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.

• Virtual reality experience: physical symptoms

  Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.

• Virtual reality experience: eye-related symptoms

  Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.

• Well-being

  Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.

Study Arms (4)

Experimental Group 1: VR-based intervention with motivational messages

ACTIVE COMPARATOR

Participants will receive a VR-based physical exercise intervention featuring a virtual coach (an older adult peer) who provides both instructions and motivational messages based on Self-Determination Theory (SDT) during the session.

Behavioral: VR-based physical activity with motivational stimuli

Experimental Group 2: VR-based intervention without motivational messages

ACTIVE COMPARATOR

Participants will receive a VR-based physical exercise intervention featuring a virtual coach (an older adult peer) who provides both instructions and informative messages during the session.

Behavioral: VR-based physical activity without motivational stimuli

Control Group 1: standard physical activity intervention with motivational messages

ACTIVE COMPARATOR

Participants will take part in a standard physical activity intervention led by a real coach who provides both instructions and motivational messages based on SDT.

Behavioral: Standard Physical Activity with motivational stimuli

Control Group 2: standard physical activity intervention without motivational messages

ACTIVE COMPARATOR

Participants will take part in a standard physical activity intervention led by a real coach who provides both instructions and informative messages.

Behavioral: Standard Physical Activity without motivational stimuli

Interventions

VR-based physical activity with motivational stimuli BEHAVIORAL

Participants will undergo four weekly supervised VR-based training sessions, each lasting approximately 35 minutes, over four weeks. Each session includes: 1. VR Warm-Up: Activities adapted from NVIDIA VR Fun House on SteamVR, involving repetitive movements through mini-games like throwing objects, archery, and sword handling. 2. Aerobic and Balance Exercises: Walking in place within a virtual natural environment, incorporating stretching steps and one-leg balance tasks. 3. Lower-Body Training: VR-based exercises such as Balloon Game for hip flexibility (popping balloons with foot movements), Cave Game for squatting motions, and sit-to-stand activities. 4. Upper-Body Training: VR exercises involving racket-based ball hitting and reaching activities at varied distances. Participants received motivational messages from a virtual coach designed to enhance the three psychological needs outlined in Self-Determination Theory: competence, autonomy, and relatedness.

Experimental Group 1: VR-based intervention with motivational messages

VR-based physical activity without motivational stimuli BEHAVIORAL

Participants will undergo four weekly supervised VR-based training sessions, each lasting approximately 35 minutes, over four weeks. Each session includes: 1. VR Warm-Up: Activities adapted from NVIDIA VR Fun House on SteamVR, involving repetitive movements through mini-games like throwing objects, archery, and sword handling. 2. Aerobic and Balance Exercises: Walking in place within a virtual natural environment, incorporating stretching steps and one-leg balance tasks. 3. Lower-Body Training: VR-based exercises such as Balloon Game for hip flexibility (popping balloons with foot movements), Cave Game for squatting motions, and sit-to-stand activities. 4. Upper-Body Training: VR exercises involving racket-based ball hitting and reaching activities at varied distances. In this condition, instead of motivational stimuli, participants received neutral information regarding the activity (e.g., "This exercise is good for your legs ").

Experimental Group 2: VR-based intervention without motivational messages

Standard Physical Activity with motivational stimuli BEHAVIORAL

Participants will engage in four individual training sessions, supervised by a trainer, scheduled once per week for a total duration of four weeks. Each session will last approximately 35 minutes and include: 5 minutes of warm-up and stretching, 10 minutes of aerobic and balance exercises (walking in place, heel raises, knee lifts, leg curls), 10 minutes of lower-body exercises (squats), and 10 minutes of upper-body exercises (shoulder abduction 180°, shoulder flexion 180°, shoulder external rotation 90°, bending 35°, trunk extensions 80°). Participants received motivational messages from a real coach designed to enhance the three psychological needs outlined in Self-Determination Theory: competence, autonomy, and relatedness.

Control Group 1: standard physical activity intervention with motivational messages

Standard Physical Activity without motivational stimuli BEHAVIORAL

Participants will engage in four individual training sessions, supervised by a trainer, scheduled once per week for a total duration of four weeks. Each session will last approximately 35 minutes and include: 5 minutes of warm-up and stretching, 10 minutes of aerobic and balance exercises (walking in place, heel raises, knee lifts, leg curls), 10 minutes of lower-body exercises (squats), and 10 minutes of upper-body exercises (shoulder abduction 180°, shoulder flexion 180°, shoulder external rotation 90°, bending 35°, trunk extensions 80°). In this condition, instead of motivational stimuli, participants received neutral information regarding the activity (e.g., "This exercise is good for your legs ").

Control Group 2: standard physical activity intervention without motivational messages

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• University of Rome Tor Vergata: collaborator

Study Sites (1)

Sapienza University of Rome

Rome, Italy, 00185, Italy

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Fabio Lucidi

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomized controlled trial, including 60 older adults, were divided into four groups each involved in a 4 week intervention under 4 different conditions.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 23, 2025
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)