NCT07701317

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

Healty volunteersExecutive FunctionMotor skillsexergamefall risk

Outcome Measures

Primary Outcomes (11)

  • 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.

    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

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline and after 6 weeks of intervention

Secondary Outcomes (1)

  • International Physical Activity Questionnaire for Adults (IPAQ-EIT)

    Baseline

Study Arms (2)

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.

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.

Behavioral: Gross motor-cognitive training

Interventions

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

Exergame group

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

Gross motor-cognitive Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Palermo

Palermo, Pa, 90144, Italy

Location

Related Publications (5)

  • 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.

    PMID: 21441997BACKGROUND
  • Berryman 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.

    PMID: 25194940BACKGROUND
  • Gregoire 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.

    PMID: 31031639BACKGROUND
  • Gallou-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.

    PMID: 32768594BACKGROUND
  • Yang 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.

    PMID: 42016049BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 14, 2026

Study Start

January 22, 2025

Primary Completion

January 26, 2026

Study Completion

May 31, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Locations