Feasibility of High-intensity Functional Exercise with Simultaneous Cognitive Challenge for Older People with Falls Risk

Официальное название

The Feasibility of a High-intensity Functional Exercise Program with Simultaneous Cognitive Challenge to Improve Physical and Cognitive Function in Older People with Intermediate Risk for Falls: a Randomized Controlled Pilot Trial

Обзор

This study aims to evaluate the feasibility of a high-intensity functional exercise program with simultaneous cognitive challenge (HIFE+cog) among older people at risk of falls. The evaluation design and intervention development will be assessed with the following specific aims: 1. To investigate the acceptability and safety of the HIFE+cog program in older people at risk of falls, and the methods used in the study by evaluating recruitment, compliance with the intervention, severity of adverse events reported, and participant experiences. 2. To measure key outcome variables, including completion rates, missing data, estimates, variances, and 95% confidence intervals for between-group differences. The study is designed as a randomized controlled pilot trial. Eligible participants will be randomized to either the intervention group (HIFE+cog) or the active control group (HIFE) to partake in individually tailored exercise, supervised and progressed by a physiotherapist, two times per week for 3 months.

Вмешательства

• Другое HIFE+cog
  Each session will consist of individually tailored exercises performed at weight- bearing positions and covering lower leg strengthening exercises, as well as static- and dynamic balance exercises. Simultaneous cognitive exercises are added to static and dynamic balance exercises. Relative exercise intensity is encouraged to be moderate to high, and progressively adjusted by for example altering load or difficulty of the exercise. Session duration is 1 hour, including warm-up.
• Другое HIFE
  Each session will consist of individually tailored exercises performed at weight- bearing positions and covering lower leg strengthening exercises, as well as static- and dynamic balance exercises. Relative exercises intensity is encouraged to be moderate to high, and progressively adjusted by for example altering load or difficulty of the exercise. Session duration is 1 hour, including warm-up.

Первичные конечные точки

• Recruitment [Срок оценки: Before intervention start]
• Adherence [Срок оценки: Through the 3-month intervention]
• Exercise intervention content and delivery [Срок оценки: Through the 3-month intervention]
• Retention [Срок оценки: Through the 3-month intervention]
• Safety [Срок оценки: Through the 3-month intervention period]
• Balance and gait capacity [Срок оценки: Baseline, 3 months]
• Balance and gait capacity [Срок оценки: Baseline, 3 months]
• Balance and gait capacity [Срок оценки: Baseline, 3 months]
• Balance and gait capacity [Срок оценки: Baseline, 3 months]
• Balance and gait capacity [Срок оценки: Baseline, 3 months]

Вторичные конечные точки (7)

• Fear of falling [Срок оценки: Baseline, 3 months]
• Psychological wellbeing [Срок оценки: Baseline, 3 months]
• Physical activity [Срок оценки: Baseline, 3 months]
• Depressive disorders [Срок оценки: Baseline, 3 months]
• Health related quality of life [Срок оценки: Baseline, 3 months]
• Activities of daily life (ADL) [Срок оценки: Baseline, 3 months]
• Descriptive information [Срок оценки: Baseline]

Критерии участия

Критерии включения

• aged 75 years or older
• moderate risk of falling (feeling unsteady or afraid of falling, or having fallen in the past year, with a self-selected gait speed ≤0,8 m/s or TUG >15 s without walking aid)
• can walk independently indoors, without a walking aid
• can walk 500m independently outdoors, with or without a walking aid

Критерии исключения

• a high fall risk (≥2 falls in the past year, serious injury e.g. hip fracture from a fall in the past year requiring medical care, or inability to get up from the floor after a fall)
• Mini-Mental State Examination (MMSE) score <24 or dementia diagnosis
• a medical condition that may affect participation in high-intensity gait, balance, and leg strength exercise, or other movement-related conditions affecting exercise or tests (e.g., pain, dizziness, visual or hearing impairment)

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

Профилактика

Центры проведения

Швеция · 1 центр

• Umeå University — Umeå

Идентификаторы

NCT: NCT06774508 · Dnr 2024-07683-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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