HealthyNCT06939621
Trajectories for Active and Healthy Aging
A study testing VR-based physical activity with motivational stimuli, VR-based physical activity without motivational stimuli and Standard Physical Activity with motivational stimuli in people with Healthy and Older Adults (65 Years and Older), run by University of Roma La Sapienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Older Adults (65 Years and Older), Virtual Reality
- What is being tested?
- VR-based physical activity with motivational stimuli, VR-based physical activity without motivational stimuli and Standard Physical Activity with motivational stimuli
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- VR-based physical activity with motivational stimuli, VR-based physical activity without motivational stimuli, Standard Physical Activity with motivational stimuli, Standard Physical Activity without motivational stimuli
- Keywords
- Older adult, Virtual Reality, Physical Activity, Self-Determination Theory, Motivation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based physical activity with motivational stimuliBehavioural
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.
VR-based physical activity without motivational stimuliBehavioural
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 ").
Standard Physical Activity with motivational stimuliBehavioural
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.
Standard Physical Activity without motivational stimuliBehavioural
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 ").
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Standard Physical Activity without motivational stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Jun 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Responsible party
- Principal investigator, Andrea Chirico, University of Roma La Sapienza
- Investigators
- Fabio Lucidi, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939621
- Sponsor's protocol ID
- CERT_1908372DCC2
- Status last verified
- Apr 2025
- First submitted
- 18 Mar 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectories for Active and Healthy Aging (Behavioural and Psychological Determinants)
- ClinicalTrials.gov ID
- NCT06939621
- Acronym / sponsor ID
- CERT_1908372DCC2
- Keywords
- Older adult, Virtual Reality, Physical Activity, Self-Determination Theory, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1: VR-based intervention with motivational messages | Active comparator | Behavioral: VR-based physical activity with motivational stimuliParticipants 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. |
| Experimental Group 2: VR-based intervention without motivational messages | Active comparator | Behavioral: VR-based physical activity without motivational stimuliParticipants 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. |
| Control Group 1: standard physical activity intervention with motivational messages | Active comparator | Behavioral: Standard Physical Activity with motivational stimuliParticipants will take part in a standard physical activity intervention led by a real coach who provides both instructions and motivational messages based on SDT. |
| Control Group 2: standard physical activity intervention without motivational messages | Active comparator | Behavioral: Standard Physical Activity without motivational stimuliParticipants will take part in a standard physical activity intervention led by a real coach who provides both instructions and informative messages. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-based physical activity with motivational stimuliParticipants 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. | Behavioural | Experimental Group 1: VR-based intervention with motivational messages |
| VR-based physical activity without motivational stimuliParticipants 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 "). | Behavioural | Experimental Group 2: VR-based intervention without motivational messages |
| Standard Physical Activity with motivational stimuliParticipants 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. | Behavioural | Control Group 1: standard physical activity intervention with motivational messages |
| Standard Physical Activity without motivational stimuliParticipants 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 "). | Behavioural | Control Group 2: standard physical activity intervention without motivational messages |
Primary outcome
Physical activity
Time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
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.
Basic Psychological Needs
Time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
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.
Motivation for physical activity
Time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
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").
General Physical Health
Time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
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.
General Mental Health
Time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
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.
Physiological measures of Physical Activity: Hearth rate variability
Time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
Hearth rate variability was measure through the smartwatch EMPATICA EmbracePlus.
Physiological measures of Physical Activity: galvanic conductance
Time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
Galvanic conductance was measure through the smartwatch EMPATICA EmbracePlus.
Physical activity
Time frame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
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.
Basic Psychological Needs
Time frame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
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.
Motivation for physical activity
Time frame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
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").
General Physical Health
Time frame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
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.
General Mental Health
Time frame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
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.
Physiological measures of Physical Activity: hearth rate variability
Time frame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
Hearth rate variability was measure through the smartwatch EMPATICA EmbracePlus.
Physiological measures of Physical Activity: galvanic conductance
Time frame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
Galvanic conductance was measure through the smartwatch EMPATICA EmbracePlus.
Physical activity
Time frame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
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.
Basic Psychological Needs
Time frame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
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.
Motivation for physical activity
Time frame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
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").
General Physical Health
Time frame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
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.
General Mental Health
Time frame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
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.
Physiological measures of Physical Activity: hearth rate variability
Time frame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
Hearth rate variability was measure through the smartwatch EMPATICA EmbracePlus.
Physiological measures of Physical Activity: galvanic conductance
Time frame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
Galvanic conductance was measure through the smartwatch EMPATICA EmbracePlus.
Physical activity
Time frame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
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.
Basic Psychological Needs
Time frame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
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.
Motivation for physical activity
Time frame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
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").
General Physical Health
Time frame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
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.
General Mental Health
Time frame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
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.
Physiological measures of Physical Activity: galvanic conductance
Time frame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Galvanic conductance was measure through the smartwatch EMPATICA EmbracePlus.
Physiological measures of Physical Activity: hearth rate variability
Time frame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Hearth rate variability was measure through the smartwatch EMPATICA EmbracePlus.
16 secondary outcomes
Well-being
Time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
Self-Efficacy for exercise
Time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
Virtual reality experience: physical symptoms
Time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
Virtual reality experience: eye-related symptoms
Time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.
Well-being
Time frame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
Self-Efficacy for exercise
Time frame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
Virtual reality experience: physical symptoms
Time frame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
Virtual reality experience: eye-related symptoms
Time frame: Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.
Well-being
Time frame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
Self-Efficacy for exercise
Time frame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
Virtual reality experience: physical symptoms
Time frame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
Virtual reality experience: eye-related symptoms
Time frame: Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.
Well-being
Time frame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Self-Efficacy for exercise
Time frame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Virtual reality experience: physical symptoms
Time frame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Virtual reality experience: eye-related symptoms
Time frame: Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Lucidi principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based physical activity with motivational stimuli, VR-based physical activity without motivational stimuli and Standard Physical Activity with motivational stimuli in people with Healthy and Older Adults (65 Years and Older), run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Week 1, day 1 (Exercise session 1). The measurement will take place after and before the exercise session.). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.