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Идёт набор NCT05978336

SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults

Без фазы С лечением Limitation, Mobility Older Adults

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: Health Coaching Program, Health Education Program.
Кому может быть актуально
Состояния в реестре: Limitation, Mobility, Older Adults. Базовые параметры: 70 лет — 89 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this randomized controlled trial is to investigate the effectiveness of a health-coaching intervention to improve physical activity in older adults with limited mobility when compared to a control, health education group.

Подробное описание

A total of 290 older adults with limited mobility will be randomized to either a 26-week health coaching program or health education program. Outcomes will be assessed at baseline, 13-weeks, 26-weeks (end of intervention), and 52 week (6-month follow-up period).

Вмешательства

  • Поведенческое Health Coaching Program
    The HC program will be delivered over 26-weeks. Participants will have an initial hour-long HC session where the BAP coach will conduct a brief physical assessment and work with the participant to establish their physical activity goals and develop a plan. After the initial consult, coaches will conduct 8 x 20-minute phone calls with participants over the 26-week trial decreasing from bi-weekly phone calls in weeks 1-12 to monthly phone calls in weeks 13-26. Participants in the HC group will ha
  • Поведенческое Health Education Program
    Participants will begin with a one-hour, group-based, interactive education session on falls prevention delivered either in-person or by Zoom. Following the initial education session, ED participants will receive additional group education sessions (in-person or by Zoom) with the same duration and schedule as the HC program covering a variety of healthy aging topics.

Первичные конечные точки

  • Mobility [Срок оценки: Baseline, 13-weeks, 26-weeks, 52-weeks]
Вторичные конечные точки (12)
  • Physical activity [Срок оценки: Baseline, 13-weeks, 26-weeks, 52-weeks]
  • Self reported physical activity [Срок оценки: Baseline, 13-weeks, 26-weeks, 52-weeks]
  • Gait speed [Срок оценки: Baseline, 13- weeks, 26-weeks, 52-weeks]
  • Capacity to complete the 400-m walk in ≤ 15 minutes [Срок оценки: Baseline, 13- weeks, 26-weeks, 52-weeks]
  • Cognitive function [Срок оценки: Baseline, 26-weeks, 52-weeks]
  • Community mobility [Срок оценки: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]
  • Functional mobility [Срок оценки: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]
  • Fatigue [Срок оценки: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]
  • Lower extremity strength [Срок оценки: Baseline, 13- weeks, 26-weeks, 52-weeks]
  • Grip strength [Срок оценки: Baseline, 13-weeks, 26-weeks, 52-weeks]
  • Mood [Срок оценки: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]
  • Health-related quality of life [Срок оценки: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]

Критерии участия

Критерии включения

  • scored ≤ 9/12 on the SPPB
  • are able to complete the 400-m walk in ≤ 15 minutes without sitting or physical assistance from another person or walker (use of cane is acceptable)
  • scored 22/30 or higher on the Mini-Mental State Examination (MMSE)
  • have no significant functional impairment as indicated by a score of 6/8 or higher on the Lawton and Brody Instrumental Activities of Daily Living Scale
  • are able to safely engage in MVPA as indicated by the PAR-Q+ and by the family or study physician as necessary
  • are community-dwelling
  • are able to provide written informed consent.

Критерии исключения

  • are diagnosed with dementia or stroke
  • self-report engaging in MVPA ≥ 10 minutes per week in the prior 3 months
  • are unable to understand, speak, and read English proficiently

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Vancouver Coastal Health Research Institute Research Pavilion — Vancouver

Публикации

  • Rice J, Li LC, Davis JC, Pahor M, Madden K, Wei N, Wong H, Skelton DA, McCormick S, Falck RS, Barha CK, Rhodes RE, Loomba S, Sadatsafavi M, Liu-Ambrose T. Supporting physical activity for mobility in older adults with mobility limitations (SuPA Mobility): study protocol for a randomized controlled trial. Trials. 2023 Nov 28;24(1):769. doi: 10.1186/s13063-023-07798-9. PMID 38017467

Идентификаторы

NCT: NCT05978336 · H21-00858

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗