NCT07270094

Brief Summary

Population ageing is associated with declines in motor and cognitive functions, which compromise autonomy and increase the risk of falls and cognitive impairment. Dual-task training programs have demonstrated additional benefits for physical and cognitive health compared with motor exercise alone. Aquatic environments provide unique advantages for older adults, facilitating movement execution and increasing adherence. However, evidence comparing aquatic dual-task training with conventional aquatic exercise remains scarce. This randomized, controlled, double-blind trial aims to compare the effects of an aquatic dual-task training program with those of a conventional aquatic exercise program on cognitive and motor functions in cognitively preserved older adults. Eighty-four participants aged 65 years or older were recruited, screened for eligibility, and randomly assigned to one of two groups: the Dual-Task Aquatic Group (n = 42) or the Conventional Aquatic Exercise Group (n = 42). The 12-week intervention consisted of two weekly sessions of 45 minutes. Cognitive (Montreal Cognitive Assessment; Mini-Mental State Examination) and motor outcomes (Timed Up and Go Test; Berg Balance Scale) were assessed pre- and post-intervention. Statistical analyses included intra- and inter-group comparisons using non-parametric tests, with a significance level of 5%. The dual-task group demonstrated significant improvements in balance, functional mobility, and cognitive performance, while the control group showed improvements only in motor outcomes. Between-group comparisons revealed superior cognitive gains in the dual-task group, with no differences in motor outcomes. Adherence exceeded 95% in both groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

November 18, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

Aquatic physiotherapyDual taskOlder adultsCognitive functionFunctional mobilityBalance

Outcome Measures

Primary Outcomes (4)

  • Mini-Mental State Examination

    The Mini-Mental State Examination (MMSE) assesses global cognitive status, including orientation, attention and calculation, memory, language, and visuospatial abilities. The total score ranges from 0 to 30. Education-adjusted cut-offs commonly used to indicate preserved cognition are: * Illiterate: ≥16 * 1-11 years of education: ≥23 * More than 11 years of education: ≥28

    Baseline (pre-intervention) and 12 weeks (post-intervention).

  • Timed Up and Go Test

    The Timed Up and Go Test evaluates functional mobility, including strength, balance, and gait. The participant stands up from a chair, walks 3 meters, turns, returns to the chair, and sits down. Performance is measured in seconds. Times under 10 seconds generally reflect good mobility, while times above 13.5 seconds indicate increased fall risk.

    Baseline (pre-intervention) and 12 weeks (post-intervention).

  • Montreal Cognitive Assessment

    The Montreal Cognitive Assessment (MoCA) evaluates executive functions, memory, attention, language, visuospatial abilities, abstraction, and orientation. The total score ranges from 0 to 30, with scores below 26 suggesting possible cognitive impairment. One additional point is added for individuals with fewer than 12 years of education.

    Baseline (pre-intervention) and 12 weeks (post-intervention).

  • Berg Balance Scale

    The Berg Balance Scale assesses static and dynamic balance through 14 functional tasks such as standing, reaching, turning, and transferring. Each item is scored from 0 to 4, with a maximum total score of 56. Scores of 40 or below indicate an increased risk of falls.

    Baseline (pre-intervention) and 12 weeks (post-intervention).

Secondary Outcomes (1)

  • Adherence to Intervention

    Throughout the 12-week intervention.

Study Arms (2)

Aquatic Dual-Task Training (GDTA)

EXPERIMENTAL

A 12-week aquatic dual-task training program, consisting of two 45-minute sessions per week, combining motor exercises with concurrent cognitive tasks.

Behavioral: Aquatic Dual-Task Training

Conventional Aquatic Exercise (GEAC)

ACTIVE COMPARATOR

A 12-week aquatic exercise program, consisting of two 45-minute sessions per week, including standard therapeutic aquatic exercises without cognitive dual-task components.

Behavioral: Conventional Aquatic Exercise

Interventions

Participants perform the same structured aquatic exercise program as the experimental group, including mobility, balance, and functional strengthening tasks, but without the addition of cognitive challenges. Exercises are performed in a single-task motor condition, representing standard aquatic physiotherapy practice.

Conventional Aquatic Exercise (GEAC)

Participants perform a structured aquatic exercise program including mobility, balance, and functional strengthening tasks. In the experimental arm, each motor task is performed simultaneously with a cognitive task (dual-task condition), including attention, memory, and executive-function challenges (e.g., verbal fluency, counting backwards, category switching).

Aquatic Dual-Task Training (GDTA)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Adults aged 65 years or older.
  • Cognitively preserved, defined as a Mini-Mental State Examination (MMSE) score equal to or above reference values adjusted for education: illiterate ≥16; 1-11 years of schooling ≥23; more than 11 years ≥28.
  • Prior experience of 3-6 months with regular aquatic physical therapy (2 sessions per week) to ensure familiarity and adaptation to the aquatic environment.
  • Medically cleared to perform moderate-intensity aquatic exercise, confirmed by:
  • Orthopedic Assessment: No severe musculoskeletal conditions preventing safe participation.
  • Clinical Risk Classification: Low to moderate risk according to the American College of Sports Medicine (ACSM) Risk Stratification.
  • Functional Capacity: Duke Activity Status Index score ≥7.

You may not qualify if:

  • Requirement for walking aids, as this interferes with safety and exercise execution.
  • Previous diagnosis of progressive and severe neurological diseases, such as Parkinson's disease, Amyotrophic Lateral Sclerosis, or dementias, that could compromise response to intervention.
  • Clinical conditions preventing safe aquatic exercise, including unstable cardiovascular disease, urinary or fecal incontinence, transmissible infectious or dermatological diseases, severe psychiatric disorders, severe respiratory conditions, or acute musculoskeletal limitations.
  • Participation in other physical or cognitive training programs during the intervention period.
  • Inability to understand or sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica de Fisioterapia e Desporto de Pombal

Pombal, 3100-462, Portugal

Location

Study Officials

  • Helena S Morgado, BSc

    Instituto Politécnico de Leiria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 8, 2025

Study Start

April 21, 2025

Primary Completion

August 29, 2025

Study Completion

October 26, 2025

Last Updated

December 8, 2025

Record last verified: 2025-12

Locations