Effects of a Home-based Therapeutic Exercise Program on Frailty in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Frailty: Fried's Frailty Phenotype:
研究概览
简要总结
The aim of this protocol is to evaluate the effects of a home-based therapeutic exercise program applied in patients with PD to reverse frailty. The design of this study is experimental, prospective, randomized and single blind. The study population that will be part of this study will be men and women with a diagnosis of PD belonging to the Health Area V of the Health Service of the Principality of Asturias, Spain.
详细描述
Introduction: Parkinson's disease (PD) is the association of tremor, rigidity, akinesia-bradykinesia and loss of postural reflexes. Non-motor symptoms such as cognitive impairment may also develop. Frailty is a syndrome characterized by a decrease in physiological reserve that results in an individual's increased vulnerability, which can lead to a variety of adverse factors when exposed to stressors. There are three prominent theoretical frameworks for the study of frailty, the physical model developed by Fried et al., the deficit accumulation model by Rockwood et al. and the biopsychosocial model by Gobbens et al. PD and frailty are highly prevalent in older people and are associated with increased morbidity and mortality. Frailty is a reversible condition, especially during the early stages, so early detection is important. Previous studies have been carried out with the application of exercise programs to reverse frailty in older adults, obtaining good results at a physical level.
General objective:
- Evaluate the effects of a therapeutic home exercise program applied in patients with PD to reverse frailty.
Specific objectives:
- Evaluate the effects of a home therapeutic exercise program on motor and non-motor symptoms, as well as on quality of life, balance and gait.
- Identify the characteristics of the patients who obtain the greatest improvement.
- Evaluate the effects of a home therapeutic exercise program after a period of time of three months after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, aged 60 years or older, with a diagnosis of PD
- •Having frailty or prefrailty according to the Fried scale (1 or 2 prefrailty criteria, 3 or more frailty criteria).
- •Stage 1-3 of the Hoehn and Yahr scale.
- •Patients who have been referred to the Home Rehabilitation Service of the Instituto de Rehabilitación Astur S.A.
- •Obtaining a score higher than 24 points in the Mini Mental State Examination (MMSE).
- •Signing the informed consent form.
排除标准
- •Parkinsonisms secondary, plus or atypical (progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, Lewy body disease).
- •Acute disease causing clinical instability.
- •Stage 4 and 5 of the Hoehn and Yahr scale.
- •Receiving individualized outpatient or home physiotherapy treatment for Parkinson's disease or secondary parkinsonism.
- •Patients unable to speak.
- •Patients in terminal phase.
- •Patient with dementia.
结局指标
主要结局
Frailty: Fried's Frailty Phenotype:
时间窗: Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.
Fried's Frailty Phenotype proposed in the Cardiovascular Health Study (Fried et al., 2001) consists of 5 criteria: unintentional weight loss, exhaustion, low physical activity, reduced grip strength, and reduced gait speed. It has a total score ranging from 0 to 5. A frail person is who scores 3 to 5; prefrail when scores 1 to 2, and robust when scores 0.
Frailty: Clinical Frailty Scale.
时间窗: Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.
The Clinical Frailty Scale (CFS) was proposed in the Canadian Study of Health and Aging (CSHA) (Rockwood et al., 2005). It is a hierarchical scale of 9 levels ranging from 1, the best state of health, to 9, the worst situation: fit, well, well managed, vulnerable, mildly frail, moderately frail, severely frail, very severely frail, terminally ill.
次要结局
- Barthel Index(Baseline - 8 weeks - 3 months)
- Comorbidities Charlson Index(Baseline - 8 weeks - 3 months)
- Movement Disorder Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).(Baseline - 8 weeks - 3 months)
- Short Physical Performance Battery activity level(Baseline - 8 weeks - 3 months)
- Quality of life, PDQ-39(Baseline - 8 weeks - 3 months)
- Cognitive function: Parkinson's Disease Cognitive Rating Scale (PD-CRS).(Baseline - 8 weeks - 3 months)
- Lawton Brody Index(Baseline - 8 weeks - 3 months)
- Walking evaluation FAC(Baseline - 8 weeks - 3 months)
- Timed Up and Go (TUG)(Baseline - 8 weeks - 3 months)
研究者
María Cruz Sousa Fraguas
Principal Investigator. Physiotherapist.
University of Oviedo