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Completed

NCT Number: NCT07050654

Motivation While Doing Physical Exercise in a Social Dual-task Virtual Environment

The goal of this interventional study is to assess the difference in participants' motivation while performing a virtual reality-based dual-task exercise in a single-player vs. multi-player modality. The populations involved are the following: healthy young adults (14-18 ys.); children and adolescents (12-17 ys.) with motor disorders; older adults with neurological or respiratory conditions. The main questions it aims to answer are:

Is a "social" virtual environment better in promoting motivation to perform physical exercise? Is a "social" virtual environment better in promoting involvement, perceived social inclusion, and exercise performance?

Forty participants will test the single-player and the multi-player scenarios in a single-session and will rate their experiences with subjective questionnaires. A subgroup of participants (12) will use the multi-player system for 3 weeks/3 times a week.

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Key information

Conditions

Healthy Volunteer Brain Damage, Chronic Brain Diseases COPD Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Cerebrovascular Disorders Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Stroke Vascular Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS E. Medea, Bosisio Parini, LC, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For IRCCS E. Medea: patients 12 years and older with neuromotor pathologies;
  • For Villa Beretta: adults with neurological pathologies;
  • For INRCA Casatenovo: patients with chronic respiratory diseases, clinical stability for at least 4 weeks;
  • Healthy volunteers: healthy students aged 14-18 years.

Exclusion criteria

  • Absence of appropriate cognitive abilities to interact with virtual reality software;
  • Presence of severe sensory deficits (visual acuity, auditory perception) such as to interfere with the administration of the proposed activities;
  • Poor trunk control or physical limitations (excessive spasticity or joint limitations) that impair the safe performance of the pedaling activity. Presence of epilepsy or treatment with antiepileptic drugs, where the physician highlights contraindications;
  • Participation in other standardized rehabilitation protocols involving lower limbs and walking.

Specifically, for INRCA Casatenovo:

  • clinical instability (pH <7.35, hemodynamic instability, resting tachypnea);
  • acute exacerbations in the month prior to enrollment;
  • cognitive impairment such that participation in rehabilitation activities is impaired (Mini Mental State Examination < 24);
  • cardiovascular decompensation NYHA (New York Heart Association) class III and IV;
  • major cardiac arrhythmias;
  • active solid or hematologic neoplasms;
  • recent myocardial infarction (< 6 months);
  • orthopedic clinical conditions that interfere with exercise.

Treatment and study plan

Dual-task cycling

Device

Pairs of participants are formed, who will be the SocialBike players; these pairs consist of users from the same center. The two players are in the same room where two replicas of the SocialBike system are installed.

The participants can each view, on their own screen, the virtual scenario, either a park or a city environment. Movement within these VR environments is synchronized with the patient's actual pedaling speed, measured in revolutions per minute (RPM) from the cycle ergometer. Movement occurs along a predefined path. The participant's heart rate will always be monitored.

The therapist chooses the optimal ergometer workload, the type of exercise, and social/single-player mode. Each session (either single- or multi-player mode) lasts 10 minutes. The available exercise are: "Find the intruder" (go/no-go task); "Prepare your Meal" (spatial attention); "Watch the road" (working memory).

Primary outcomes

  1. Motivation

    Time frame: Day 1 - at the end of the test with Condition 1 (single- or multi-player); Day 1 - at the end of the test with Condition 2 (multi- or single-player). At the end of the 4th and the 8th sessions for the participants performing 3 weeks of training.

    Situational Motivation Scale (SIMS; Guay et al. 2000). This questionnaire is composed of 16 items to be rated with a Likert scale going from 1 (corresponds not all) to 7 (corresponds exactly). Items are grouped in four different subscale (Intrinsic Motivation, Identified Regulation, External Regulation, Amotivation). Each subscale score can vary between 1 (minimum) and 7 (maximum).

Secondary outcomes

  1. Usability

    Time frame: Day 1

    System Usability Scale (Brooke, 1996) - The scale ranges from 0 to 100. Higher scores indicate better usability.

    Ratings can be described as follows: "Excellent" (85-100); "Good" (70-84); "Average" (50-69); "Poor" (<50).

  2. Involvement

    Time frame: Day 1 - at the end of the test with Condition 1 (single- or multi-player); Day 1 - at the end of the test with Condition 2 (multi- or single-player). At the end of the 4th and the 8th sessions for the participants performing 3 weeks of training.

    Game Experience Questionnaire (GEQ) (IJsselsteijn, et al., 2013)- GEQ is composed of several subscales: Competence, Sensory and Imaginative Immersion, Flow, Tension/Annoyance, Challenge, Negative Affect, Positive Affect.

    Each subscale ranges from 0, which means "Not at all", and 4, which means "Extremely". Higher score corresponds stronger experience in that dimension.

  3. Perceived social inclusion

    Time frame: Day 1 - at the end of the test with Condition 1 (single- or multi-player); Day 1 - at the end of the test with Condition 2 (multi- or single-player). At the end of the 4th and the 8th sessions for the participants performing 3 weeks of training.

    ad-hoc question; the question will address how much participants feel included while performing the physical activity. The answer ranges from 0 "not at all" to 4 "completely included".

  4. Game and physical performance

    Time frame: Data are stored automatically by the system each time the application is launched. Outcomes data are collected during each session of SocialBike use, i.e., during the single-sessions and each session of the 3 weeks of training.

    The system automatically stores a file containing each player game and physical data for the session. In particular, the file will contain the exercise information: scenario, duration, task performed, level of difficulty, game mode (collaborative/competitive). In terms of performance, the following outcomes will be collected: average speed [revolutions per minute], average heart rate [beats per minute], personal score in the cognitive task [# points collected], final score in [# points collected by the two players if collaborative, equal to personal if competitive].

  5. Endurance

    Time frame: At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).

    Assisted 6-minute cycling test (A6MCT)

  6. Physical activity inclination

    Time frame: At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).

    Ad-hoc question; the question will address how much participants are motivated in performing physical activity. The answer ranges from 0 "not at all" to 4 "extremely motivated".

  7. Attitude toward technology

    Time frame: At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).

    Ad-hoc question; the question will address how much participants feel at ease while interacting with technology. The answer ranges from 0 "not at all" to 4 "extremely at ease".

Sponsors and collaborators

Lead sponsor

Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato

Other

Collaborators

  • IRCCS Eugenio Medea
  • Istituto Nazionale di Ricovero e Cura per Anziani
  • Villa Beretta Rehabilitation Center

Registry information

Official study title

Studio Della Motivazione All'Esercizio Fisico in modalità Social Dual-task in Ambiente di realtà Virtuale Non Immersiva" Nell'Ambito Del Progetto ActivE3 - Everyone, Everywhere, Everyday "Rif. 2021-0612 - CUP C13C21000200005

Acronym: ActivE3

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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