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Completed

NCT Number: NCT07701317

Effects of Exergame and Gross Motor-Cognitive Training in Older Adults: An RCT

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Palermo

Palermo, Pa, 90144, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Older Adults;
  • Age ≥ 60 years;
  • Independent in carrying out activities of daily living.

Exclusion criteria

  • 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%

Treatment and study plan

allenamento tramite Exergame

Behavioral

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 training

Behavioral

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Secondary outcomes

  1. International Physical Activity Questionnaire for Adults (IPAQ-EIT)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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