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Набор скоро начнётся NCT06814678

Interactive Exergaming With Otago Exercise Program on Mobility in Community-Dwelling Older Adults

Без фазы С лечением Physical Functional Performance Psychological Health Physical Fitness Mobility Limitation

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: Interactive Exergaming with Otago Exercise Program, Control Group with Usual Care.
Кому может быть актуально
Состояния в реестре: Physical Functional Performance, Psychological Health, Physical Fitness, Mobility Limitation. Базовые параметры: 65 лет — 99 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effectiveness of Interactive Exergaming Combined With the Otago Exercise Program on Mobility in Older Individuals Living in Communities: A Cluster-Randomized Controlled Study

Обзор

This clinical trial aims to evaluate the effectiveness of interactive exergaming combined with Otago Exercise Program on mobility among community-dwelling older adults aged 65 and above. The main research questions are: Does this combined exercise intervention improve elderly mobility? Does this program enhance muscle strength and psychological well-being? Researchers will compare two groups: one group will do the combined exercise program for 12 weeks, while the other group will continue their usual activities. Participants will: * Have their health checked three times: at the start, after 12 weeks, and 3 months later * If in the exercise group, attend exercise sessions twice a week for 12 weeks * Complete tests about their physical abilities and how they feel emotionally Who can take part: * Adults age 65 or older * People who need more than 12 seconds to stand up and sit down 5 times * People who can stand for at least 30 seconds with support People cannot take part if they have serious vision problems, recent leg injuries, major illnesses, significant memory problems, or mental health conditions.

Подробное описание

This cluster-randomized controlled trial investigates the integration of interactive exergaming with the evidence-based Otago Exercise Program (OEP) to enhance mobility among community-dwelling older adults. The study employs comprehensive methodology and rigorous assessment protocols to evaluate intervention effectiveness.

Methodology and Technical Implementation:

Assessment Tools and Measurements:

Primary Outcome Measures:

ICOPE (Integrated Care for Older People) screening tool evaluating six domains: cognition, mobility, nutrition, vision, hearing, and depression

Short Physical Performance Battery (SPPB, ICC=0.81-0.91) measuring:

Balance (side-by-side, semi-tandem, tandem stance) Gait speed (3-meter walk test) Lower extremity strength (5-time sit-to-stand)

Lower extremity muscle strength assessment using MicroFET2 digital dynamometer (accuracy ±1%):

Quadriceps strength Ankle dorsiflexion Hip abduction

Secondary Outcome Measures:

Three-Item Loneliness Scale (T-ILS, Cronbach's α=0.87) Geriatric Depression Scale-5 (GDS-5) Well-being Scale for Older Adults (9 items, Cronbach's α=0.91)

Intervention Protocol Design:

Exercise Program Structure:

12-week intervention period Two 60-minute sessions per week (120 minutes total) Group format (10-25 participants) Led by certified OEP trainers Integration of Nex Playground exergaming system

Session Components:

1. Warm-up (10 minutes):

Head and neck rotations Back stretches Upper body rotation Lower limb stretches 2. Otago Exercise Program (30 minutes):

Knee lifts Ankle movements Knee extensions Standing exercises with support Heel-toe exercises Sit-to-stand practice 3. Interactive Exergaming (20 minutes):

Virtual soccer targeting lower limb strength Fruit Ninja for upper body engagement Alternating activities to prevent fatigue 4. Cool-down (10 minutes):

Stretching exercises Relaxation techniques

Technical Implementation:

Equipment and Setting:

Spacious, well-ventilated rooms Sturdy chairs with armrests Nex Playground gaming system Large display screen/projector Non-slip exercise mats Safety rails/supports

Safety Protocols:

Environmental risk assessment Fall prevention measures Emergency response procedures Continuous monitoring by trained staff Regular equipment maintenance

Quality Control Measures:

Standardization:

Assessor training (ICC \> 0.80 required) Intervention delivery protocols Documentation procedures Data collection methods

Blinding:

Outcome assessors blinded to group allocation Separate staff for intervention and assessment Data coding for anonymity

Monitoring:

Attendance tracking Adverse event documentation Intervention fidelity checks Regular team meetings

Statistical Analysis Framework:

Primary Analysis:

Intention-to-treat principle Generalized Estimating Equations (GEE) Repeated measures analysis Cluster-level adjustments

Data Management:

Coded data entry Regular quality checks Missing data protocols Interim analyses

Methodological Considerations:

Cluster Randomization:

Unit of randomization: community centers Stratification by center size Baseline characteristic balance Intraclass correlation adjustment

Вмешательства

  • Поведенческое Interactive Exergaming with Otago Exercise Program
    Participants will receive a 12-week structured program combining interactive exergaming and Otago Exercise Program. Sessions include balance training, strength exercises, and functional mobility activities delivered through interactive gaming platforms, supervised by trained instructors.
  • Другое Control Group with Usual Care
    Participants will maintain their regular activities at community centers or facilities, including cognitive therapy, oral exercises, and upper limb training programs, during the 12-week study period

Первичные конечные точки

  • Mobility Performance [Срок оценки: Baseline, 12 weeks, 3 months]
  • Lower Extremity Strength [Срок оценки: Baseline, 12 weeks, 3 months]
Вторичные конечные точки (4)
  • Intrinsic Capacity Score [Срок оценки: baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)]
  • Loneliness Level [Срок оценки: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)]
  • Depression Symptoms [Срок оценки: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)]
  • Well-being Status [Срок оценки: Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2)]

Критерии участия

Критерии включения

  • Age ≥ 65 years
  • Abnormal mobility based on ICOPE screening (Five-time chair stand test > 12 seconds)
  • Able to stand holding handrail for > 30 seconds

Критерии исключения

  • Severe visual impairment
  • Lower limb fracture
  • Acute serious illness
  • Moderate to severe cognitive impairment (SPMSQ > 5 errors)
  • Diagnosed psychiatric disorders

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

Тайвань · 1 центр
  • No. 105, Yusheng Street, Shilin District, Taipei City 111, Taiwan — Taipei

Идентификаторы

NCT: NCT06814678 · 202412HM008 · Taiwan Nurses Association

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗