Trajectories for Active and Healthy Aging

Trajectories for Active and Healthy Aging (Behavioural and Psychological Determinants)

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Physical Activity; Virtual Reality; Older Adults (65 Years and Older)
• Intervention / Treatment: Behavioral: VR-based physical activity with motivational stimuli; Behavioral: VR-based physical activity without motivational stimuli; Behavioral: Standard Physical Activity with motivational stimuli; Behavioral: Standard Physical Activity without motivational stimuli

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00185
    • Sapienza University of Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental Group 1: VR-based intervention with motivational messages; 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; Participants will undergo four weekly supervised VR-based training sessions, each lasting approximately 35 minutes, over four weeks. Each session includes: 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.; Aerobic and Balance Exercises: Walking in place within a virtual natural environment, incorporating stretching steps and one-leg balance tasks.; 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.; 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.
Active Comparator: Experimental Group 2: VR-based intervention without motivational messages; 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; Participants will undergo four weekly supervised VR-based training sessions, each lasting approximately 35 minutes, over four weeks. Each session includes: 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.; Aerobic and Balance Exercises: Walking in place within a virtual natural environment, incorporating stretching steps and one-leg balance tasks.; 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.; 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 ").
Active Comparator: Control Group 1: standard physical activity intervention with motivational messages; 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; 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.
Active Comparator: Control Group 2: standard physical activity intervention without motivational messages; 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; 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 ").

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-being	The Subjective Vitality/Depletion Scale was use to assess well-being. This self-report questionnaire is composed of six items rated on a 7-point Likert scale (from 1 = "Not at all true" to 7 = "Very true"). Higher scores are indicative of higher well-being.	Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
Self-Efficacy for exercise	The Self-Efficacy for Exercise Scale (SEE) is a self-report questionnaire composed of nine items for the assessment of self-efficacy for exercise, specifically designed for older adults. Each item is rated on an 11-point scale (from 0 = "Not confident" to 10 = "Very confident"). Scores ranges from a minimum of 0 to a maximum of 90. Larger values reflects higher degree of confidence that an elder has in engaging in exercise in the presence of specific barriers.	Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
Virtual reality experience: physical symptoms	Virtual Reality Symptoms Questionnaire. This self-report questionnaire comprises 13 items divided into two dimensions: physical symptoms (8 items) and eye-related symptoms (5 items). Each item is rated on a 7-point Likert scale (ranging from 0 = "none" to 6 = "severe"). Scores for physical symptoms range from 0 to 48. Higher scores indicate greater discomfort.	Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
Virtual reality experience: eye-related symptoms	Virtual Reality Symptoms Questionnaire. This self-report questionnaire comprises 13 items divided into two dimensions: physical symptoms (8 items) and eye-related symptoms (5 items). Each item is rated on a 7-point Likert scale (ranging from 0 = "none" to 6 = "severe"). Scores for eye-related symptoms range from 0 to 40. Higher scores indicate greater discomfort.	Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
Well-being	The Subjective Vitality/Depletion Scale was use to assess well-being. This self-report questionnaire is composed of six items rated on a 7-point Likert scale (from 1 = "Not at all true" to 7 = "Very true"). Higher scores are indicative of higher well-being.	Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
Self-Efficacy for exercise	The Self-Efficacy for Exercise Scale (SEE) is a self-report questionnaire composed of nine items for the assessment of self-efficacy for exercise, specifically designed for older adults. Each item is rated on an 11-point scale (from 0 = "Not confident" to 10 = "Very confident"). Scores ranges from a minimum of 0 to a maximum of 90. Larger values reflects higher degree of confidence that an elder has in engaging in exercise in the presence of specific barriers.	Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
Virtual reality experience: physical symptoms	Virtual Reality Symptoms Questionnaire. This self-report questionnaire comprises 13 items divided into two dimensions: physical symptoms (8 items) and eye-related symptoms (5 items). Each item is rated on a 7-point Likert scale (ranging from 0 = "none" to 6 = "severe"). Scores for physical symptoms range from 0 to 48. Higher scores indicate greater discomfort.	Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
Virtual reality experience: eye-related symptoms	Virtual Reality Symptoms Questionnaire. This self-report questionnaire comprises 13 items divided into two dimensions: physical symptoms (8 items) and eye-related symptoms (5 items). Each item is rated on a 7-point Likert scale (ranging from 0 = "none" to 6 = "severe"). Scores for eye-related symptoms range from 0 to 40. Higher scores indicate greater discomfort.	Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
Well-being	The Subjective Vitality/Depletion Scale was use to assess well-being. This self-report questionnaire is composed of six items rated on a 7-point Likert scale (from 1 = "Not at all true" to 7 = "Very true"). Higher scores are indicative of higher well-being.	Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
Self-Efficacy for exercise	The Self-Efficacy for Exercise Scale (SEE) is a self-report questionnaire composed of nine items for the assessment of self-efficacy for exercise, specifically designed for older adults. Each item is rated on an 11-point scale (from 0 = "Not confident" to 10 = "Very confident"). Scores ranges from a minimum of 0 to a maximum of 90. Larger values reflects higher degree of confidence that an elder has in engaging in exercise in the presence of specific barriers.	Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
Virtual reality experience: physical symptoms	Virtual Reality Symptoms Questionnaire. This self-report questionnaire comprises 13 items divided into two dimensions: physical symptoms (8 items) and eye-related symptoms (5 items). Each item is rated on a 7-point Likert scale (ranging from 0 = "none" to 6 = "severe"). Scores for physical symptoms range from 0 to 48. Higher scores indicate greater discomfort.	Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
Virtual reality experience: eye-related symptoms	Virtual Reality Symptoms Questionnaire. This self-report questionnaire comprises 13 items divided into two dimensions: physical symptoms (8 items) and eye-related symptoms (5 items). Each item is rated on a 7-point Likert scale (ranging from 0 = "none" to 6 = "severe"). Scores for eye-related symptoms range from 0 to 40. Higher scores indicate greater discomfort.	Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
Well-being	The Subjective Vitality/Depletion Scale was use to assess well-being. This self-report questionnaire is composed of six items rated on a 7-point Likert scale (from 1 = "Not at all true" to 7 = "Very true"). Higher scores are indicative of higher well-being.	Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Self-Efficacy for exercise	The Self-Efficacy for Exercise Scale (SEE) is a self-report questionnaire composed of nine items for the assessment of self-efficacy for exercise, specifically designed for older adults. Each item is rated on an 11-point scale (from 0 = "Not confident" to 10 = "Very confident"). Scores ranges from a minimum of 0 to a maximum of 90. Larger values reflects higher degree of confidence that an elder has in engaging in exercise in the presence of specific barriers.	Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Virtual reality experience: physical symptoms	Virtual Reality Symptoms Questionnaire. This self-report questionnaire comprises 13 items divided into two dimensions: physical symptoms (8 items) and eye-related symptoms (5 items). Each item is rated on a 7-point Likert scale (ranging from 0 = "none" to 6 = "severe"). Scores for physical symptoms range from 0 to 48. Higher scores indicate greater discomfort.	Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Virtual reality experience: eye-related symptoms	Virtual Reality Symptoms Questionnaire. This self-report questionnaire comprises 13 items divided into two dimensions: physical symptoms (8 items) and eye-related symptoms (5 items). Each item is rated on a 7-point Likert scale (ranging from 0 = "none" to 6 = "severe"). Scores for eye-related symptoms range from 0 to 40. Higher scores indicate greater discomfort.	Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Collaborators: University of Rome Tor Vergata
• Investigators: Principal Investigator: Fabio Lucidi, University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Motivation; Virtual Reality; Older adult; Self-Determination Theory
• Other Study ID Numbers: CERT_1908372DCC2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No