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Идёт набор NCT07156708

Aquatic Exercises Combined With Cognitive Tasks for Older Adults

Без фазы С лечением Aging

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Aquatic aerobic exercise program, Cognitive tasks.
Кому может быть актуально
Состояния в реестре: Aging. Базовые параметры: 60 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Aquatic Aerobic Exercises Combined With Cognitive Tasks on Cognitive Function and Other Health-related Outcomes in Older Adults

Обзор

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.

Вмешательства

  • Другое Aquatic aerobic exercise program
    The aquatic exercise sessions include the following exercises: butt kick, frontal kick, cross-country skiing, and stationary running. These exercises are commonly used in water aerobics classes and provide controlled osteoarticular impact, being safe for older women (Alberton et al., 2019). Training intensity is prescribed using Borg's 6-20 rating of perceived exertion (RPE) scale. The adopted strategy is based on interval training, which alternates between high-intensity effort and low-intensit
  • Другое Cognitive tasks
    This group performs the same aerobic training protocol used by the conventional aquatic program group. Additionally, cognitive tasks are performed during the active recovery phases. Cognitive training encompasses different domains of cognition in all sessions, including semantic fluency, processing speed, cognitive flexibility, inhibitory control, memory, attention, and reasoning. The exercises vary in each class, with progression in complexity in each mesocycle.

Первичные конечные точки

  • Objective cognitive function - Digit Span Test [Срок оценки: Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25)]
  • Objective cognitive function - Controlled Oral Word Association Test [Срок оценки: Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25)]
Вторичные конечные точки (12)
  • Objective cognitive function - Trail Making Test (TMT) [Срок оценки: Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25)]
  • Self-perception of cognitive function [Срок оценки: Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25)]
  • Aerobic fitness [Срок оценки: Baseline (week 0) to post-training (week 13)]
  • Lower limb strength [Срок оценки: Baseline (week 0) to post-training (week 13)]
  • Upper limb strength [Срок оценки: Baseline (week 0) to post-training (week 13)]
  • Lower limb flexibility [Срок оценки: Baseline (week 0) to post-training (week 13)]
  • Agility and dynamic balance [Срок оценки: Baseline (week 0) to post-training (week 13)]
  • Dual-task performance [Срок оценки: Baseline (week 0) to post-training (week 13)]
  • Blood pressure [Срок оценки: Baseline (week 0) to post-training (week 13)]
  • Blood pressure reactivity [Срок оценки: Baseline (week 0) to post-training (week 13)]
  • Heart rate variability [Срок оценки: Baseline (week 0) to post-training (week 13)]
  • Depressive and anxiety symptoms [Срок оценки: Baseline (week 0) to post-training (week 13)]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Бразилия · 1 центр
  • Escola Superior de Educação Física e Fisioterapia — Pelotas

Публикации

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  • Sao-Joao TM, Rodrigues RC, Gallani MC, Miura CT, Domingues Gde B, Godin G. [Cultural adaptation of the Brazilian version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire]. Rev Saude Publica. 2013 Jun;47(3):479-87. doi: 10.1590/s0034-8910.2013047003947. Portuguese. PMID 24346560
  • Brucki SM, Nitrini R, Caramelli P, Bertolucci PH, Okamoto IH. [Suggestions for utilization of the mini-mental state examination in Brazil]. Arq Neuropsiquiatr. 2003 Sep;61(3B):777-81. doi: 10.1590/s0004-282x2003000500014. Epub 2003 Oct 28. Portuguese. PMID 14595482
  • Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese. PMID 10881154
  • Bertolazi AN, Fagondes SC, Hoff LS, Dartora EG, Miozzo IC, de Barba ME, Barreto SS. Validation of the Brazilian Portuguese version of the Pittsburgh Sleep Quality Index. Sleep Med. 2011 Jan;12(1):70-5. doi: 10.1016/j.sleep.2010.04.020. Epub 2010 Dec 9. PMID 21145786
  • Botega NJ, Bio MR, Zomignani MA, Garcia C Jr, Pereira WA. [Mood disorders among inpatients in ambulatory and validation of the anxiety and depression scale HAD]. Rev Saude Publica. 1995 Oct;29(5):355-63. doi: 10.1590/s0034-89101995000500004. Portuguese. PMID 8731275
  • Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available. PMID 8737210
  • STROOP, J. R. Studies of interference in serial verbal reactions. Journal of Experimental Psychology, v. 18, n. 6, p. 643-662, 1935.

Идентификаторы

NCT: NCT07156708 · 90526525.0.0000.5313

Первоисточники (государственные реестры)

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