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临床试验/NCT06939621
NCT06939621已完成不适用

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

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Physiological measures of Physical Activity: Hearth rate variability

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •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).

研究组 & 干预措施

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.

干预措施: VR-based physical activity with motivational stimuli (Behavioral)

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.

干预措施: VR-based physical activity without motivational stimuli (Behavioral)

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.

干预措施: Standard Physical Activity with motivational stimuli (Behavioral)

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.

干预措施: Standard Physical Activity without motivational stimuli (Behavioral)

结局指标

主要结局

Physiological measures of Physical Activity: Hearth rate variability

时间窗: 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

时间窗: 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

时间窗: 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.

Physical activity

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Physical activity

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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: galvanic conductance

时间窗: 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

时间窗: 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.

Physiological measures of Physical Activity: galvanic conductance

时间窗: 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.

Basic Psychological Needs

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Physical activity

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Well-being(Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.)
  • Self-Efficacy for exercise(Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.)
  • Virtual reality experience: physical symptoms(Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.)
  • Virtual reality experience: eye-related symptoms(Week 4, day 4 (Exercise session 4). The measurement will take place after and before the exercise session.)
  • 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.)
  • Self-Efficacy for exercise(Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.)
  • Virtual reality experience: physical symptoms(Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.)
  • Virtual reality experience: eye-related symptoms(Week 2, day 2 (Exercise session 2). The measurement will take place after and before the exercise session.)
  • Well-being(Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.)
  • Self-Efficacy for exercise(Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.)
  • Virtual reality experience: physical symptoms(Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.)
  • Virtual reality experience: eye-related symptoms(Week 3, day 3 (Exercise session 3). The measurement will take place after and before the exercise session.)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Chirico

Associate Professor

University of Roma La Sapienza

研究点 (1)

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