Active Aging Individuals Aged 60 and OverNCT07701317
Effects of Exergame and Gross Motor-Cognitive Training in Older Adults: An RCT
A study testing allenamento tramite Exergame and Gross motor-cognitive training in people with Active Aging Individuals Aged 60 and Over, run by University of Palermo at 1 site in Italy.
Trial summary
Background: Aging leads to a progressive decline in gross-motor skills and executive functions, significantly increasing fall risks. While exergaming and motor-cognitive training are effective countermeasures, literature lacks direct comparisons and data on long-term retention. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Active Aging Individuals Aged 60 and Over
- What is being tested?
- allenamento tramite Exergame and Gross motor-cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jan 2025to 31 May 2026
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older Adults;
- Age ≥ 60 years;
- Independent in carrying out activities of daily living.
Who cannot join
- Unstable cardiovascular, respiratory, or neurological conditions that contraindicate exercise;
- Recent fractures, major orthopedic surgery, or acute musculoskeletal pain limiting safe exercise participation.
- An attendance rate below 80%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exergame and Gross Motor-cognitive Training on Executive Functions and Gross Motor Skills in Self-sufficient Older Adults: a Randomized Controlled Trial With 20-week Follow-up.
Background: Aging leads to a progressive decline in gross-motor skills and executive functions, significantly increasing fall risks. While exergaming and motor-cognitive training are effective countermeasures, literature lacks direct comparisons and data on long-term retention.
Purpose:This study compares the effects of an exergaming intervention against a structured gross motor-cognitive training program in older adults, with both protocols lasting 6 weeks. It evaluates the short- and medium-term (20-week follow-up) maintenance of physical and cognitive benefits, while introducing a novel composite gross-motor index.
Methods \& Question: The study addresses which intervention is more effective at improving gross-motor coordination and executive functions, and whether these adaptations persist over time.
Read the detailed description
This randomized controlled trial with an active control group compares the effects of an interactive exergaming intervention against a structured gross motor-cognitive training program in older adults, while evaluating the short- and medium-term maintenance of physical and cognitive benefits through a 20-week follow-up and introducing a novel composite gross-motor index. This study was conducted from March 2025 to February 2026, with recruitment initiating in January 2025, as part of the Physical Activity Promotion \& Domestic Accidents Prevention project, a collaboration between the University of Palermo and the Azienda Sanitaria Provinciale of Palermo, Italy. A total of 108 community-dwelling older adults, comprising 84 women and 24 men aged over 60, who were independent in activities of daily living and scored $\ge 24$ on the Mini-Mental State Examination, voluntarily participated and were randomly allocated to either the Experimental Group ($n = 65$, mean age: $72.05 \pm 5.8$ years) receiving exergame-based training, or the Active Control Group ($n = 43$, mean age: $71.58 \pm 4.2$ years) receiving gross motor-cognitive training. All sessions and assessments took place in a controlled environment at the University Sports Center and the Pietro Pisani gymnasium, and a total of 79 participants successfully completed the 6-week intervention, representing a physiological drop-out rate of 26.85%. The study was approved by the Ethical Board of the University of Palermo (N. 111/2022) and conformed to the Declaration of Helsinki. Outcome assessments were performed at baseline, immediately post-intervention at 6 weeks, and at a 20-week follow-up, with a researcher evaluating gross motor skills using the Ruler Drop Test, Plate Tapping Test, Foot Tapping Test, Timed Up and Go Test, Aiming Task Test, and the Clap-and-Catch Task, while a psychologist assessed cognitive functions via the Phonemic Verbal Fluency Test, a modified version of the Grooved Pegboard Test, the Symbol Digit Modalities Test, the Digit Span Forward and Backward, and the short version of the Stroop Color-Word Test. Physical activity levels at baseline were also assessed using the International Physical Activity Questionnaire for Adults (IPAQ-EIT). Both protocols lasted 6 weeks with a frequency of 2 sessions per week, where each 90-minute session consisted of a 15-minute warm-up, a 60-minute core phase, and a 15-minute cool-down focused on stretching and respiratory exercises. For the Gross Motor-Cognitive Training group, the core phase included five group-based exercises targeting gross motor coordination, such as locomotion drills, obstacle clearing, rhythmic movements, static or dynamic balance, and object manipulation, with each task strictly paired with concurrent or sequential cognitive or motor dual-tasks like backward counting or color-number associations under progressive overload. In contrast, the Exergame-Based Training group engaged in interactive, playful-competitive exercises developed via graphic design software and custom virtual motor courses designed within Minecraft creative mode, which were projected onto a wall for simultaneous group interaction to create complex dual-task environments where motor actions like balance, target throwing, and walking drills were directly subordinate to processing visual and auditory cues, with the difficulty progressing bi-weekly following gamification principles including increased stimulus speed, time-based challenges, and score tracking.
Statistical analyses were conducted using Linear Mixed Models (LMM), a mixed statistical model ideal for longitudinal studies involving repeated measurements of the same subjects over multiple time points (pre-test, post-test, and follow-up) and highly effective for handling missing data.
- Being tested
- allenamento tramite Exergame, Gross motor-cognitive training
- Keywords
- Healty volunteers, Executive Function, Motor skills, exergame, fall risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allenamento tramite ExergameBehavioural
The protocol begins with a 10-minute warm-up focused on mobility.The central phase features 5 exergaming exercises for coordination and dual-tasking. Ex 1: participants step on floor colors matching wall projections to music (repeated twice, 2-min rest). Ex 2: pairs mimic an immersive Minecraft video pathway, ending with a color-sequencing race (6 times, 2-min rest). Ex 3: pairs sum projected dice, navigate an obstacle/ladder course with a ball, shoot into a parity-coded basket, and complete a multi-task return loop (4 rounds, 2 sets, 2-min rest). Ex 4: pairs hold projected poses for 10s, then race to grab vowel/consonant-coded markers (3 sets, 2-min rest). Ex 5: participants tap a 4-quadrant numerical screen in chronological order, combined with timed ball-transfers (3 progressive speed sets). A 10-min cool-down follows with torso stretches, lunges, and deep breathing
Gross motor-cognitive trainingBehavioural
The protocol begins with a 10-minute warm-up focused on mobility. The central phase consists of 5 multi-stage exercises targeting gross-motor coordination and dual-tasking. In Exercise 1, pairs perform rhythmic movements to music (high knees, stepping) for 5 repetitions before passing a ball, repeated twice per song with a 2-3 min rest. Exercise 2 involves walking along a wall and tapping colored targets on cue (3 sets of 10 reps, performed twice, 40s rest). In Exercise 3, participants navigate a course with obstacles, an agility ladder, and a backward-counting slalom, ending with a target throw (4 rounds, 2 sets). Exercise 4 targets partner single-leg balance, holding a stance or tapping feet for 10s/10 reps (3 sets, performed twice, 30s rest). Exercise 5 enhances reaction time via partner ball-passing and grabbing floor markers based on semantic/arithmetic cues (10 reps, 2 blocks per set, 30s rest). Finally, a 10-minute cool-down promotes recovery through stretching and deep breathin
| Study group | Role | What they receive |
|---|---|---|
| Exergame group | Experimental | Participants randomly assigned to this arm undergo a screen-projected, interactive video game training program (exergaming). The intervention targets gross-motor control, multi-sensory integration, and executive functions through simulated gaming pathways, virtual tasks, and automated visual/auditory cues. Receives: Behavioral: allenamento tramite Exergame |
| Gross motor-cognitive Group | Experimental | Participants randomly assigned to this arm undergo a structured gross motor-cognitive training program under a dual-task paradigm. The intervention targets motor coordination, balance, and cognitive execution using traditional equipment (balls, grids, agility ladders, targets) combined with verbal and rhythmic tasks. Receives: Behavioral: Gross motor-cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time (Ruler drop test)
The test measures the time it takes for a person to react to a falling ruler by measuring how far the object falls before it is caught. The distance will be recorded in cm by measuring from the zero point to the highest part of the participant's hand. If the ruler is dropped to the ground, a score of 51 cm is assigned by adding 1 cm. Only one practice trial will be performed to familiarize the participant with the test, which will then be executed 3 times, using the average distance in cm for data analysis. The reaction time will be calculated using the formula t = √2d/g, where d is the distance traveled by the ruler in meters, g is the acceleration of gravity (9,81 m/s2), and t is the ruler's fall time in seconds.
Measured: Baseline and after 6 weeks of intervention
Plate Tapping Test: Assessment of Upper Limb Motor Speed
The test assesses the time taken by the upper limbs to perform lateral movements in a sequential, orderly, and rhythmic back-and-forth manner as quickly as possible. A square wooden board measuring 20 cm by 10 cm and 1 cm thick is used, which is fixed to the table surface with double-sided tape. Two circles with a diameter of 20 cm are placed on the sides at a distance of 80 cm from each other, while the board is located 40 cm away from each lateral circle. The subject sits facing the table with the apparatus and places one hand in the center of the square board. Upon the researcher's "go" signal, the participant performs 25 complete cycles of back-and-forth tapping movements between the left and right circles as quickly as possible. The hand placed in the center must not be touched. The test is performed with both the right and left hands. To count the taps, the researcher relies on the sound produced by the fingers hitting the surface. The test is executed twice, and use the average
Measured: Baseline and after 6 weeks of intervention
10-Second Foot Tapping Test
The test assesses the speed of foot movements by executing as many taps as possible in 10 seconds. Participants sit on a chair with their hips and knees at an angle of approximately 90 degrees, and the foot positioned on one side of a board. Upon the researcher's "go" signal, the participant must perform as many taps as possible within 10 seconds on both sides of the board, ensuring that the forefoot makes contact with the floor. The test is performed while wearing shoes. The procedure is executed twice, and the average number of taps is used for data analysis. The test is performed with both the right and left foot.
Measured: Baseline and after 6 weeks of intervention
Throwing and Aiming Ability:Aiming Task Test
The test measures object control capacity through throwing and aiming. A target with a diameter of 25 cm is fixed to the wall at an height corresponding to the average height of the tested participants, and a tennis ball is used. The participant must throw the tennis ball from a distance of 8 feet (2.44 m) from the wall, where a line is drawn. The participant can choose to perform either an underhand or an overhand throw. One practice trial is performed to choose the throwing method. The number of successful throws out of 10 attempts is recorded for both the right and left hands.
Measured: Baseline and after 6 week of intervention
Complex Motor Coordination: The Clap-and-Catch Task Test
The test measures the ability to coordinate two sequential motor actions through a multi-stage task consisting of throwing, clapping, and catching. It assesses the nervous system's capacity to transition rapidly from one motor action to another in a fluid and orderly manner. Participants are instructed to throw the ball upward and catch it with the same hand. They must insert a hand clap between the throw and the catch, with the number of claps increasing during the attempts up to a maximum of four. Three attempts are given for each level, and the maximum number of claps successfully achieved is recorded. Each hand is tested separately.
Measured: Baseline and after 6 weeks of intervention
The phonemic fluency test:language production
The test is used to assess language production, executive function, and cognitive flexibility. Participants are instructed to generate as many words as possible within 1 min that begin with a specific letter, while excluding proper nouns and words that differ only by their suffixes. The letters used in the task are 'F', 'A', and 'S'. A score is given for each word produced that correctly adheres to the provided rules, with a total duration of 3 min (1 min per letter). A score below 17.35 is considered indicative of a pathological condition.
Measured: Baseline and after 6 week of intervention
Grooved Pegboard Test (GPT)
This test assesses manual dexterity, fine motor control, visuomotor coordination, motor planning, speed, precision, and coordination. Participants insert as many keyhole-shaped pegs as possible into slotted holes within 1 minute. The slots are oriented in various directions, which increases complexity compared to standard pegboards and requires enhanced visuomotor integration and executive control. This task demands precise motor execution, real-time visuospatial processing, and executive planning, offering insights into sensorimotor pathways, cortical-subcortical networks, and frontal-executive systems. The test is administered in three consecutive one-minute trials, each performed with the participant's preferred hand. The total score, up to a maximum of 75, is calculated as the cumulative number of pegs successfully inserted across all three trials.
Measured: Baseline and after 6 week of intervention
The Symbol Digit Modalities Test
The test is used to assess processing speed, attention, and working memory The test presents a key in which nine unique symbols are each paired with a digit from 1 to 9. Participants are required to rapidly write the digit corresponding to each symbol by referring to the key. The task is time-limited to 90 s, during which participants must complete as many correct symbol-digit pairings as possible. The total score is determined by the number of correct associations made within the time limit. A score below 34.20 is considered indicative of impaired performance.
Measured: Baseline and after 6 week of intervention
The Digit Span forward and backward test
The test is used to assess short-term verbal memory span and verbal working memory span. Participants are required to repeat sequences of digits that progressively increase in length, both in the same order (forward) and in reverse order (backward). The span score for each condition is defined as the longest sequence of digits correctly recalled following a single presentation. The normative cut-off scores are 4.26 for the forward span and 2.65 for the backward span.
Measured: Baseline and after 6 week of intervention
The short version of the Stroop Color-Word Test
The test is used to assess interference inhibition, a component of executive functioning. The test evaluates both the number of ink colors correctly identified out of 30 color words and the time required to complete the task. Performance is considered within the normal range if the number of errors does not exceed 4.24 and the completion time is below 36.92 s.
Measured: Baseline and after 6 week of intervention
Time up and go Test (TUG)
The TUG test was performed using a standard armchair secured against a wall and a 3-meter distance marked on the floor. From a seated starting position, upon the "go" command, participants stood up, walked at a comfortable pace to the 3-meter mark, turned around, returned, and sat back down. Timing started with the verbal cue and stopped when the participant's buttocks touched the seat, with the recorded time used for data analysis.
Measured: Baseline and after 6 weeks of intervention
Secondary outcomes (1)
International Physical Activity Questionnaire for Adults (IPAQ-EIT)
The International Physical Activity Questionnaire for Adults (IPAQ-EIT), aims to identify the types of physical activities that individuals perform in their daily lives, specifically measuring the amount of walking, moderate, and vigorous activity they undertake. By calculating the Metabolic Equivalent of Task (MET) values, the tool enabled the assessment of the participants' baseline physical activity levels.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start22 Jan 2025
- Primary completion26 Jan 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Active Aging Individuals Aged 60 and OverStudies 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
- Parallel groups
- Model description
- This study utilized a randomized controlled trial design with an active control group to investigate and compare the efficacy of two distinct 6-week training modalities in older adults. Participants were randomly allocated into two separate arms, with the Experimental Group undergoing an interactive, digital exergame-based training program and the Active Control Group participating in a structured gross motor-cognitive training program.To evaluate the immediate impact and sustainability of the interventions, physical and cognitive outcomes were assessed across three time points: a baseline pre-test, a post-test immediately following the 6-week training period, and a follow-up 20 weeks later to measure medium-term benefit retention.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianna Bellafiore, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701317
- Sponsor's protocol ID
- 111/2022-A
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) from this study will not be shared because the informed consent obtained from participants did not include permission for public data sharing.
Publications
Voelcker-Rehage C, Godde B, Staudinger UM. Cardiovascular and coordination training differentially improve cognitive performance and neural processing in older adults. Front Hum Neurosci. 2011 Mar 17;5:26. doi: 10.3389/fnhum.2011.00026. eCollection 2011.
PubMed 21441997Berryman N, Bherer L, Nadeau S, Lauziere S, Lehr L, Bobeuf F, Lussier M, Kergoat MJ, Vu TT, Bosquet L. Multiple roads lead to Rome: combined high-intensity aerobic and strength training vs. gross motor activities leads to equivalent improvement in executive functions in a cohort of healthy older adults. Age (Dordr). 2014;36(5):9710. doi: 10.1007/s11357-014-9710-8. Epub 2014 Sep 7.
PubMed 25194940Gregoire CA, Berryman N, St-Onge F, Vu TTM, Bosquet L, Arbour N, Bherer L. Gross Motor Skills Training Leads to Increased Brain-Derived Neurotrophic Factor Levels in Healthy Older Adults: A Pilot Study. Front Physiol. 2019 Apr 12;10:410. doi: 10.3389/fphys.2019.00410. eCollection 2019.
PubMed 31031639Gallou-Guyot M, Mandigout S, Bherer L, Perrochon A. Effects of exergames and cognitive-motor dual-task training on cognitive, physical and dual-task functions in cognitively healthy older adults: An overview. Ageing Res Rev. 2020 Nov;63:101135. doi: 10.1016/j.arr.2020.101135. Epub 2020 Aug 5.
PubMed 32768594Yang DJ, Lee HS. Exergame-based cognitive-motor integrated training: A novel approach to improving physical functions in older adults. Hong Kong Physiother J. 2026 Jun;46(1):1-13. doi: 10.1142/S1013702526500010. Epub 2026 Jan 20.
PubMed 42016049
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exergame and Gross Motor-cognitive Training on Executive Functions and Gross Motor Skills in Self-sufficient Older Adults: a Randomized Controlled Trial With 20-week Follow-up.
- ClinicalTrials.gov ID
- NCT07701317
- Acronym / sponsor ID
- 111/2022-A
- Keywords
- Healty volunteers, Executive Function, Motor skills, exergame, fall risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 14 Jul 2026 (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.
Background: Aging leads to a progressive decline in gross-motor skills and executive functions, significantly increasing fall risks. While exergaming and motor-cognitive training are effective countermeasures, literature lacks direct comparisons and data on long-term retention.
Purpose:This study compares the effects of an exergaming intervention against a structured gross motor-cognitive training program in older adults, with both protocols lasting 6 weeks. It evaluates the short- and medium-term (20-week follow-up) maintenance of physical and cognitive benefits, while introducing a novel composite gross-motor index.
Methods \& Question: The study addresses which intervention is more effective at improving gross-motor coordination and executive functions, and whether these adaptations persist over time.
Detailed description
This randomized controlled trial with an active control group compares the effects of an interactive exergaming intervention against a structured gross motor-cognitive training program in older adults, while evaluating the short- and medium-term maintenance of physical and cognitive benefits through a 20-week follow-up and introducing a novel composite gross-motor index. This study was conducted from March 2025 to February 2026, with recruitment initiating in January 2025, as part of the Physical Activity Promotion \& Domestic Accidents Prevention project, a collaboration between the University of Palermo and the Azienda Sanitaria Provinciale of Palermo, Italy. A total of 108 community-dwelling older adults, comprising 84 women and 24 men aged over 60, who were independent in activities of daily living and scored $\ge 24$ on the Mini-Mental State Examination, voluntarily participated and were randomly allocated to either the Experimental Group ($n = 65$, mean age: $72.05 \pm 5.8$ years) receiving exergame-based training, or the Active Control Group ($n = 43$, mean age: $71.58 \pm 4.2$ years) receiving gross motor-cognitive training. All sessions and assessments took place in a controlled environment at the University Sports Center and the Pietro Pisani gymnasium, and a total of 79 participants successfully completed the 6-week intervention, representing a physiological drop-out rate of 26.85%. The study was approved by the Ethical Board of the University of Palermo (N. 111/2022) and conformed to the Declaration of Helsinki. Outcome assessments were performed at baseline, immediately post-intervention at 6 weeks, and at a 20-week follow-up, with a researcher evaluating gross motor skills using the Ruler Drop Test, Plate Tapping Test, Foot Tapping Test, Timed Up and Go Test, Aiming Task Test, and the Clap-and-Catch Task, while a psychologist assessed cognitive functions via the Phonemic Verbal Fluency Test, a modified version of the Grooved Pegboard Test, the Symbol Digit Modalities Test, the Digit Span Forward and Backward, and the short version of the Stroop Color-Word Test. Physical activity levels at baseline were also assessed using the International Physical Activity Questionnaire for Adults (IPAQ-EIT). Both protocols lasted 6 weeks with a frequency of 2 sessions per week, where each 90-minute session consisted of a 15-minute warm-up, a 60-minute core phase, and a 15-minute cool-down focused on stretching and respiratory exercises. For the Gross Motor-Cognitive Training group, the core phase included five group-based exercises targeting gross motor coordination, such as locomotion drills, obstacle clearing, rhythmic movements, static or dynamic balance, and object manipulation, with each task strictly paired with concurrent or sequential cognitive or motor dual-tasks like backward counting or color-number associations under progressive overload. In contrast, the Exergame-Based Training group engaged in interactive, playful-competitive exercises developed via graphic design software and custom virtual motor courses designed within Minecraft creative mode, which were projected onto a wall for simultaneous group interaction to create complex dual-task environments where motor actions like balance, target throwing, and walking drills were directly subordinate to processing visual and auditory cues, with the difficulty progressing bi-weekly following gamification principles including increased stimulus speed, time-based challenges, and score tracking.
Statistical analyses were conducted using Linear Mixed Models (LMM), a mixed statistical model ideal for longitudinal studies involving repeated measurements of the same subjects over multiple time points (pre-test, post-test, and follow-up) and highly effective for handling missing data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study utilized a randomized controlled trial design with an active control group to investigate and compare the efficacy of two distinct 6-week training modalities in older adults. Participants were randomly allocated into two separate arms, with the Experimental Group undergoing an interactive, digital exergame-based training program and the Active Control Group participating in a structured gross motor-cognitive training program.To evaluate the immediate impact and sustainability of the interventions, physical and cognitive outcomes were assessed across three time points: a baseline pre-test, a post-test immediately following the 6-week training period, and a follow-up 20 weeks later to measure medium-term benefit retention.
| Arm | Type | Receives |
|---|---|---|
| Exergame group | Experimental | Behavioral: allenamento tramite ExergameParticipants randomly assigned to this arm undergo a screen-projected, interactive video game training program (exergaming). The intervention targets gross-motor control, multi-sensory integration, and executive functions through simulated gaming pathways, virtual tasks, and automated visual/auditory cues. |
| Gross motor-cognitive Group | Experimental | Behavioral: Gross motor-cognitive trainingParticipants randomly assigned to this arm undergo a structured gross motor-cognitive training program under a dual-task paradigm. The intervention targets motor coordination, balance, and cognitive execution using traditional equipment (balls, grids, agility ladders, targets) combined with verbal and rhythmic tasks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older Adults;
- Age ≥ 60 years;
- Independent in carrying out activities of daily living.
Key exclusion criteria (3 listed)
- Unstable cardiovascular, respiratory, or neurological conditions that contraindicate exercise;
- Recent fractures, major orthopedic surgery, or acute musculoskeletal pain limiting safe exercise participation.
- An attendance rate below 80%
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 |
|---|---|---|
| allenamento tramite ExergameThe protocol begins with a 10-minute warm-up focused on mobility.The central phase features 5 exergaming exercises for coordination and dual-tasking. Ex 1: participants step on floor colors matching wall projections to music (repeated twice, 2-min rest). Ex 2: pairs mimic an immersive Minecraft video pathway, ending with a color-sequencing race (6 times, 2-min rest). Ex 3: pairs sum projected dice, navigate an obstacle/ladder course with a ball, shoot into a parity-coded basket, and complete a multi-task return loop (4 rounds, 2 sets, 2-min rest). Ex 4: pairs hold projected poses for 10s, then race to grab vowel/consonant-coded markers (3 sets, 2-min rest). Ex 5: participants tap a 4-quadrant numerical screen in chronological order, combined with timed ball-transfers (3 progressive speed sets). A 10-min cool-down follows with torso stretches, lunges, and deep breathing | Behavioural | Exergame group |
| Gross motor-cognitive trainingThe protocol begins with a 10-minute warm-up focused on mobility. The central phase consists of 5 multi-stage exercises targeting gross-motor coordination and dual-tasking. In Exercise 1, pairs perform rhythmic movements to music (high knees, stepping) for 5 repetitions before passing a ball, repeated twice per song with a 2-3 min rest. Exercise 2 involves walking along a wall and tapping colored targets on cue (3 sets of 10 reps, performed twice, 40s rest). In Exercise 3, participants navigate a course with obstacles, an agility ladder, and a backward-counting slalom, ending with a target throw (4 rounds, 2 sets). Exercise 4 targets partner single-leg balance, holding a stance or tapping feet for 10s/10 reps (3 sets, performed twice, 30s rest). Exercise 5 enhances reaction time via partner ball-passing and grabbing floor markers based on semantic/arithmetic cues (10 reps, 2 blocks per set, 30s rest). Finally, a 10-minute cool-down promotes recovery through stretching and deep breathin | Behavioural | Gross motor-cognitive Group |
Primary outcome
Reaction time (Ruler drop test)
Time frame: Baseline and after 6 weeks of intervention
The test measures the time it takes for a person to react to a falling ruler by measuring how far the object falls before it is caught. The distance will be recorded in cm by measuring from the zero point to the highest part of the participant's hand. If the ruler is dropped to the ground, a score of 51 cm is assigned by adding 1 cm. Only one practice trial will be performed to familiarize the participant with the test, which will then be executed 3 times, using the average distance in cm for data analysis. The reaction time will be calculated using the formula t = √2d/g, where d is the distance traveled by the ruler in meters, g is the acceleration of gravity (9,81 m/s2), and t is the ruler's fall time in seconds.
Plate Tapping Test: Assessment of Upper Limb Motor Speed
Time frame: Baseline and after 6 weeks of intervention
The test assesses the time taken by the upper limbs to perform lateral movements in a sequential, orderly, and rhythmic back-and-forth manner as quickly as possible. A square wooden board measuring 20 cm by 10 cm and 1 cm thick is used, which is fixed to the table surface with double-sided tape. Two circles with a diameter of 20 cm are placed on the sides at a distance of 80 cm from each other, while the board is located 40 cm away from each lateral circle. The subject sits facing the table with the apparatus and places one hand in the center of the square board. Upon the researcher's "go" signal, the participant performs 25 complete cycles of back-and-forth tapping movements between the left and right circles as quickly as possible. The hand placed in the center must not be touched. The test is performed with both the right and left hands. To count the taps, the researcher relies on the sound produced by the fingers hitting the surface. The test is executed twice, and use the average
10-Second Foot Tapping Test
Time frame: Baseline and after 6 weeks of intervention
The test assesses the speed of foot movements by executing as many taps as possible in 10 seconds. Participants sit on a chair with their hips and knees at an angle of approximately 90 degrees, and the foot positioned on one side of a board. Upon the researcher's "go" signal, the participant must perform as many taps as possible within 10 seconds on both sides of the board, ensuring that the forefoot makes contact with the floor. The test is performed while wearing shoes. The procedure is executed twice, and the average number of taps is used for data analysis. The test is performed with both the right and left foot.
Throwing and Aiming Ability:Aiming Task Test
Time frame: Baseline and after 6 week of intervention
The test measures object control capacity through throwing and aiming. A target with a diameter of 25 cm is fixed to the wall at an height corresponding to the average height of the tested participants, and a tennis ball is used. The participant must throw the tennis ball from a distance of 8 feet (2.44 m) from the wall, where a line is drawn. The participant can choose to perform either an underhand or an overhand throw. One practice trial is performed to choose the throwing method. The number of successful throws out of 10 attempts is recorded for both the right and left hands.
Complex Motor Coordination: The Clap-and-Catch Task Test
Time frame: Baseline and after 6 weeks of intervention
The test measures the ability to coordinate two sequential motor actions through a multi-stage task consisting of throwing, clapping, and catching. It assesses the nervous system's capacity to transition rapidly from one motor action to another in a fluid and orderly manner. Participants are instructed to throw the ball upward and catch it with the same hand. They must insert a hand clap between the throw and the catch, with the number of claps increasing during the attempts up to a maximum of four. Three attempts are given for each level, and the maximum number of claps successfully achieved is recorded. Each hand is tested separately.
The phonemic fluency test:language production
Time frame: Baseline and after 6 week of intervention
The test is used to assess language production, executive function, and cognitive flexibility. Participants are instructed to generate as many words as possible within 1 min that begin with a specific letter, while excluding proper nouns and words that differ only by their suffixes. The letters used in the task are 'F', 'A', and 'S'. A score is given for each word produced that correctly adheres to the provided rules, with a total duration of 3 min (1 min per letter). A score below 17.35 is considered indicative of a pathological condition.
Grooved Pegboard Test (GPT)
Time frame: Baseline and after 6 week of intervention
This test assesses manual dexterity, fine motor control, visuomotor coordination, motor planning, speed, precision, and coordination. Participants insert as many keyhole-shaped pegs as possible into slotted holes within 1 minute. The slots are oriented in various directions, which increases complexity compared to standard pegboards and requires enhanced visuomotor integration and executive control. This task demands precise motor execution, real-time visuospatial processing, and executive planning, offering insights into sensorimotor pathways, cortical-subcortical networks, and frontal-executive systems. The test is administered in three consecutive one-minute trials, each performed with the participant's preferred hand. The total score, up to a maximum of 75, is calculated as the cumulative number of pegs successfully inserted across all three trials.
The Symbol Digit Modalities Test
Time frame: Baseline and after 6 week of intervention
The test is used to assess processing speed, attention, and working memory The test presents a key in which nine unique symbols are each paired with a digit from 1 to 9. Participants are required to rapidly write the digit corresponding to each symbol by referring to the key. The task is time-limited to 90 s, during which participants must complete as many correct symbol-digit pairings as possible. The total score is determined by the number of correct associations made within the time limit. A score below 34.20 is considered indicative of impaired performance.
The Digit Span forward and backward test
Time frame: Baseline and after 6 week of intervention
The test is used to assess short-term verbal memory span and verbal working memory span. Participants are required to repeat sequences of digits that progressively increase in length, both in the same order (forward) and in reverse order (backward). The span score for each condition is defined as the longest sequence of digits correctly recalled following a single presentation. The normative cut-off scores are 4.26 for the forward span and 2.65 for the backward span.
The short version of the Stroop Color-Word Test
Time frame: Baseline and after 6 week of intervention
The test is used to assess interference inhibition, a component of executive functioning. The test evaluates both the number of ink colors correctly identified out of 30 color words and the time required to complete the task. Performance is considered within the normal range if the number of errors does not exceed 4.24 and the completion time is below 36.92 s.
Time up and go Test (TUG)
Time frame: Baseline and after 6 weeks of intervention
The TUG test was performed using a standard armchair secured against a wall and a 3-meter distance marked on the floor. From a seated starting position, upon the "go" command, participants stood up, walked at a comfortable pace to the 3-meter mark, turned around, returned, and sat back down. Timing started with the verbal cue and stopped when the participant's buttocks touched the seat, with the recorded time used for data analysis.
1 secondary outcome
International Physical Activity Questionnaire for Adults (IPAQ-EIT)
Time frame: Baseline
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 14 Jul 2026.
- Background: PubMed 21441997Voelcker-Rehage C, Godde B, Staudinger UM. Cardiovascular and coordination training differentially improve cognitive performance and neural processing in older adults. Front Hum Neurosci. 2011 Mar 17;5:26. doi: 10.3389/fnhum.2011.00026. eCollection 2011.
- Background: PubMed 25194940Berryman N, Bherer L, Nadeau S, Lauziere S, Lehr L, Bobeuf F, Lussier M, Kergoat MJ, Vu TT, Bosquet L. Multiple roads lead to Rome: combined high-intensity aerobic and strength training vs. gross motor activities leads to equivalent improvement in executive functions in a cohort of healthy older adults. Age (Dordr). 2014;36(5):9710. doi: 10.1007/s11357-014-9710-8. Epub 2014 Sep 7.
- Background: PubMed 31031639Gregoire CA, Berryman N, St-Onge F, Vu TTM, Bosquet L, Arbour N, Bherer L. Gross Motor Skills Training Leads to Increased Brain-Derived Neurotrophic Factor Levels in Healthy Older Adults: A Pilot Study. Front Physiol. 2019 Apr 12;10:410. doi: 10.3389/fphys.2019.00410. eCollection 2019.
- Background: PubMed 32768594Gallou-Guyot M, Mandigout S, Bherer L, Perrochon A. Effects of exergames and cognitive-motor dual-task training on cognitive, physical and dual-task functions in cognitively healthy older adults: An overview. Ageing Res Rev. 2020 Nov;63:101135. doi: 10.1016/j.arr.2020.101135. Epub 2020 Aug 5.
- Background: PubMed 42016049Yang DJ, Lee HS. Exergame-based cognitive-motor integrated training: A novel approach to improving physical functions in older adults. Hong Kong Physiother J. 2026 Jun;46(1):1-13. doi: 10.1142/S1013702526500010. Epub 2026 Jan 20.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) from this study will not be shared because the informed consent obtained from participants did not include permission for public data sharing.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing allenamento tramite Exergame and Gross motor-cognitive training in people with Active Aging Individuals Aged 60 and Over, run by University of Palermo 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 3 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 14 Jul 2026. 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?
Reaction time (Ruler drop test) (time frame: Baseline and after 6 weeks of intervention). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07701317, which also lists 5 linked publications.
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 14 Jul 2026.