Effects of Specifically Developed Exercise on Falls, Physical Functioning, Physical Activity, and General Physical and Psychological Well-being Among Older Adults Dwelling in Nursing Homes Following Recommendations of International Association of Gerontology and Geriatrics-Global Aging Research Network (IAGG-GARN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of all falls (non-injurious and injurious)
研究概览
简要总结
The aim of the study is to examine the effect of multicomponent exercises recommendations on falls, physical functioning, physical activity, and general physical and psychological well-being among Hungarian older adults dwelling in nursing homes.
详细描述
Methods: Randomized controlled trial of an individually exercise guideline recommended by IAGG-GARN for older males and females living in a nursing home. A stratified randomization will be performed after the baseline assessment. The assessment of primary and secondary outcomes takes place in all subjects upon entry to the study (pre-test) by blinded assessors and at 12 weeks (post-test). After baseline assessments is completed, participants will be randomly allocated to one of the two groups using stratified randomization based on equal distribution of age and gender ratio.
Expected results:
- Reduce the incidence of falls among the nursing homes residents of the intervention group (IG)
- Increase of lower extremity physical functional ability (balance, gait speed, and strength) of the IG
- Improvement of level of physical activity independency of the IG
- Improvement of functional independency of the IG
- Improvement of physical and psychological well-being among IG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness to participate
- •Males and females aged ≥65 years living in nursing homes
- •Physically mobile (capable of ambulating/rising from chair with or without assistance)
- •Not under simultaneous physical activity/exercise investigation in other experimental studies or under other exercise rehabilitation programme
- •To be able to read and understand the self-reported assessments as well as follow the verbal instructions.
排除标准
- •Physically unable or medically unfit to participate in physical exercise after consultation of the responsible medical team
- •Score of < 18 on mini-mental state examination (MMSE).
研究组 & 干预措施
Exercise group
Physical exercise interventions for 45 min, twice a week plus usual care provided at the nursing home.
干预措施: Physical exercise interventions (Other)
Usual care
Usual care provided at the nursing home with no specific physical exercise intervention.
结局指标
主要结局
Number of all falls (non-injurious and injurious)
时间窗: During the 12-week of the intervention.
Whenever a fall occurred for any of the participants during intervention time, it will be recorded by the staff and reported on a fall incidence report. All fall will be reported; non-injurious (i.e., does not result in a physical harm), moderate injurious falls (i.e., result in bruising, sprains, cuts, abrasions, or reduction in physical function for at least three days, or if the participant sought medical help), and serious injurious falls (i.e., result in a fracture or admission to hospital with an injury or required stitches).
次要结局
- World Health Organization Quality of Life questionnaire (WHOQOL-BREF)(Baseline and 12th week.)
- Six-minute Walking Test (6MWT)(Baseline and 12th week.)
- Single Leg Stance Test (SLST)(Baseline and 12th week.)
- Mini-mental State Examination (MMSE)(Baseline and 12th week.)
- Barthel Index(Baseline and 12th week.)
- Timed Up and Go Test (TUGT)(Baseline and 12th week.)
- Functional Reach Test (FRT)(Baseline and 12th week.)
- Beck Depression Inventory (BDI-13)(Baseline and 12th week.)
- Global Physical Activity Questionnaire (GPAQ)(Baseline and 12th week.)
- Short Physical Performance Battery (SPPB)(Baseline and 12th week.)
- World Health Organization Well-Being Index (WHO-5)(Baseline and 12th week.)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline and 12th week.)
- Sedentary Behaviour Questionnaire (SBQ)(Baseline and 12th week.)
- Geriatrics Depression Scale (GDS)(Baseline and 12th week.)
研究者
Munseef Sadaqa
Principal Investigator (PhD candidate)
University of Pecs