跳至主要内容
临床试验/NCT07270094
NCT07270094已完成不适用

Effect of Dual Task in Aquatic Physical Therapy in Older Adults: A Randomized Controlled Trial

Instituto Politécnico de Leiria2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年4月21日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Mini-Mental State Examination

研究概览

简要总结

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.

详细描述

Population ageing introduces challenges associated with progressive motor and cognitive decline, increasing dependence, fall risk, and vulnerability to neurocognitive disorders. Dual-task training-combining simultaneous motor and cognitive tasks-has shown promising benefits in older adults, outperforming isolated motor exercise in several domains. The aquatic environment presents additional therapeutic advantages such as reduced joint load, enhanced balance safety, and increased adherence. Despite these strengths, few studies have rigorously compared aquatic dual-task training with conventional aquatic exercise.

This randomized, controlled, double-blind trial investigates the effects of a 12-week aquatic dual-task intervention versus conventional aquatic exercise in cognitively preserved older adults accustomed to aquatic environments. Eighty-four participants aged ≥65 years were recruited from the community and screened based on predefined eligibility criteria.

Dual-Task Aquatic Group (GDTA; n = 42): Participants performed motor exercises combined with progressively complex cognitive tasks (e.g., verbal fluency, attention, memory tasks), structured into three progressive phases across 12 weeks.

Conventional Aquatic Exercise Group (GEAC; n = 42): Participants completed a matched program of aquatic motor exercises without cognitive demands.

Both groups received two supervised 45-minute sessions per week in a therapeutic pool. Cognitive and motor functions were assessed immediately before and after the intervention using the Montreal Cognitive Assessment, Mini-Mental State Examination, Timed Up and Go Test, and Berg Balance Scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 ≥
  • 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.

排除标准

  • 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.

结局指标

主要结局

Mini-Mental State Examination

时间窗: Baseline (pre-intervention) and 12 weeks (post-intervention).

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

Timed Up and Go Test

时间窗: Baseline (pre-intervention) and 12 weeks (post-intervention).

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.

Montreal Cognitive Assessment

时间窗: Baseline (pre-intervention) and 12 weeks (post-intervention).

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.

Berg Balance Scale

时间窗: Baseline (pre-intervention) and 12 weeks (post-intervention).

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.

次要结局

  • Adherence to Intervention(Throughout the 12-week intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验