Effects of Aquatic Aerobic Exercises Combined With Cognitive Tasks on Cognitive Function and Other Health-related Outcomes in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Objective cognitive function - Digit Span Test
研究概览
简要总结
The aquatic environment has characteristics that favor the adherence of older adults to exercise programs, and studies have shown that programs in this setting are effective in enhancing various aspects of physical fitness as well as cognitive function in this population. Research has explored whether incorporating cognitive tasks into an aquatic exercise program could offer additional benefits, but it remains uncertain whether this approach leads to greater improvements in cognitive function compared to aquatic exercises alone. The present protocol reports the WaterCog Study, which aims to evaluate the effects of an aquatic aerobic exercise program combined with cognitive tasks, compared to a conventional aquatic aerobic exercise program and a control group, on cognitive function and other health-related outcomes in older adults. This trial is a randomized, single-blinded, three-arm, parallel, superiority trial. A total of 98 older adults are randomized into one of three groups: 1) an aquatic aerobic exercise program combined with cognitive tasks, 2) a conventional aquatic aerobic exercise program, and 3) a control group. Participants in both exercise groups complete a 12-week exercise program with two weekly sessions on non-consecutive days. The primary outcome is cognitive function, while secondary outcomes include physical function, cardiovascular, and psychosocial parameters. Outcomes are measured at baseline, post-intervention, and at the 12-week follow-up after the end of the intervention period. The analysis plan will employ an intention-to-treat approach and per-protocol criteria. The conceptual hypothesis of the study is that both training programs will significantly improve the investigated outcomes compared to the control group. Additionally, it is expected that aquatic exercises with cognitive tasks will promote additional benefits in cognitive function, with similar gains in physical function, cardiovascular, and psychosocial parameters compared to conventional aquatic aerobic exercises in post-intervention and follow-up measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding is applied to outcome assessors and data analysts responsible for evaluating both primary and secondary outcomes. However, due to the nature of the interventions, blinding is not feasible for the staff conducting the exercise sessions or the participants. To maintain assessor blinding, participants are instructed not to disclose their group allocation or discuss intervention details during outcome assessments.
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Older women aged 60 and 75 years;
- •Being physically inactive, meaning not participating in physical exercise for at least six months (regular exercise is defined as engaging in any physical training for a minimum of 20 minutes on two or more days a week).
排除标准
- •History of cardiovascular disease (except controlled hypertension);
- •Osteoarticular limitations for the practice of exercises;
- •Being illiterate due to the self-completion questionnaires and the characteristics of the intervention;
- •Diagnosis of dementia, schizophrenia, or major depressive disorder.
结局指标
主要结局
Objective cognitive function - Digit Span Test
时间窗: Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25)
The Digit Span Test is used to assess working memory and attention span (Schroeder et al., 2012). The Digit Span Test requires participants to verbally recall a sequence of numbers dictated by the examiner. The test begins with three numbers ranging from 0 to 9, read at 1-second intervals, which participants must remember in the correct order. The sequence increases by one digit if pronounced correctly. If participants fail to recall the correct sequence twice in a row, the test ends. The number of digits correctly recalled is recorded as the test result, with a higher score indicating better performance.
Objective cognitive function - Controlled Oral Word Association Test
时间窗: Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25)
The Controlled Oral Word Association Test (COWAT) is used to assess verbal fluency, working memory, and inhibitory control (Ross et al., 2007). In this test, participants must say as many words as possible that start with the letters "F," "A," and "S" within 1 minute for each letter. Proper names, repeated words, and variations in gender, number, and conjugation are not considered. A higher number of words in each test indicates better verbal fluency.
次要结局
- Aerobic fitness(Baseline (week 0) to post-training (week 13))
- Objective cognitive function - Trail Making Test (TMT)(Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25))
- Self-perception of cognitive function(Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25))
- Lower limb strength(Baseline (week 0) to post-training (week 13))
- Upper limb strength(Baseline (week 0) to post-training (week 13))
- Lower limb flexibility(Baseline (week 0) to post-training (week 13))
- Agility and dynamic balance(Baseline (week 0) to post-training (week 13))
- Dual-task performance(Baseline (week 0) to post-training (week 13))
- Blood pressure(Baseline (week 0) to post-training (week 13))
- Blood pressure reactivity(Baseline (week 0) to post-training (week 13))
- Heart rate variability(Baseline (week 0) to post-training (week 13))
- Depressive and anxiety symptoms(Baseline (week 0) to post-training (week 13))
- Sleep quality(Baseline (week 0) to post-training (week 13))
- Self-reported quality of life(Baseline (week 0) to post-training (week 13))
研究者
Cristine Lima Alberton
Principal Investigator
Federal University of Pelotas