Effects of Physical Exercise and Cognitive Training on Quality of Life in Older Women

Официальное название

Effects of Cognitive Training and Exercise on Cognitive Function in Older Women: the INCOGNITO Randomized Clinical Trial

Обзор

Ageing exposes people to a progressive loss of cognitive and functional abilities, especially in women. The aim of the study is to investigate the effectiveness of different types of intervention, based on physical exercise and/or cognitive stimulation or training, on quality of life, cognition and mobility, on a population of older women.

Вмешательства

• Поведенческое EXERCISE TRAINING WITH OR WITHOUT MEDICATION
  The exercise program includes 75-minute training sessions twice a week, for a total of 24 training sessions over 12 weeks. Each training session will be divided into a warm-up, training phase and cool-down, and will include aerobic exercises, resistance training, balance exercises, mobility exercises and stretching.
• Поведенческое Exercise plus cognitive training
  In addition to the exercise program, participants will be given a series of cognitive exercises aimed at improving prospective memory through the performance of certain oral tasks, administered by a member of the research team. All cognitive exercises will be adapted to the cognitive abilities of the participants.
• Поведенческое Exercise plus cognitive stimulus at home
  In addition to the exercise program, participants will receive a short video lasting less than 10 minutes on their smartphone or tablet before the exercise session (or at home). At the end of the video, they will be asked to complete a 10-question questionnaire (also delivered via smartphone or tablet) with True or False answer options.

Первичные конечные точки

• Executive function and processing speed by the Trail Making Test (TMT) [Срок оценки: Baseline; end of the program (3-month); Follow-up (6-month)]

Вторичные конечные точки (8)

• Quality of life by the Quality of Life in Alzheimer's Disease (QOL-AD) questionnaire [Срок оценки: Baseline; end of the program (3-month); Follow-up (6-month)]
• Quality of life assessed by the short-form 36 (SF-36) questionnaire [Срок оценки: Baseline; end of the program (3-month); Follow-up (6-month)]
• Cognition assessed by the Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline; end of the program (3-month); Follow-up (6-month)]
• Walking endurance assessed by the 6-Minute Walking Test (6MWT) [Срок оценки: Baseline; end of the program (3-month); Follow-up (6-month)]
• Physical performance assessed using the Short Physical Performance Battery (SPPB) [Срок оценки: Baseline; end of the program (3-month); Follow-up (6-month)]
• Manual grip strength using the Handgrip Test (HT). [Срок оценки: Baseline; end of the program (3-month); Follow-up (6-month)]
• Sleep quality and related disorders through the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline; end of the program (3-month); Follow-up (6-month)]
• Frontal and prefrontal cerebral perfusion using near-infrared spectroscopy (fNIRS). [Срок оценки: Baseline; end of the program (3-month); Follow-up (6-month)]

Критерии участия

Критерии включения

• Female
• Age ≥ 60 years
• Provision of the informed consent form

Критерии исключения

• Absolute contraindications to physical exercise (e.g. Nyha class iv heart failure, unstable angina, etc.)
• Pregnancy
• Severe cognitive impairment, defined as a MoCa score ≤ 12
• Severe visual impairment or blindness

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Esercizio Vita — Ferrara

Идентификаторы

NCT: NCT07244562 · 417/2025/Sper/UniFe

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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