Ultrasound Assessment of Muscle Architecture Before and After the Implementation of a Physical Exercise Regime in the Water in a Frail Elderly Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Muscle Architecture Improvement
研究概览
简要总结
It is an experimental, longitudinal prospective, controlled trial. The project will be developed in the General University Hospital of Valencia (CHGUV), and the University of Valencia.
Patients will be recruited from a previous cohort. The patients of this cohort will be contacted and proposed to participate. Those patients who accept, will be divided into the following experimental groups:
- Group 1: Patients in this group will perform the water exercise protocol, 3 times a week, for 12 weeks.
- Group 2: Patients in this group will not perform any type of exercise during the 12 weeks of the treatment.
Variables related to muscular quality by ultrasound, frailty, physical function, independence in the activities of daily life, balance, cognitive function, quality of life and sleep, the social sphere will be evaluated, and the intensity of pain and fatigue, before and after12 weeks of intervention.
详细描述
OBJECTIVE To evaluate changes in muscle architecture by ultrasound, before and after an intervention with physical exercise directed in water in frail individuals; and determine the correlation of the image findings with the changes detected in their morbidity, functionality and quality of life.
SAMPLE
The sample will be composed of at least 40 frail men and women, according to Frail Phenotype criteria. Patients will be recruited from a previous cohort. For the assessment of frail, Linda Fried's criteria will be used: unintentional weight loss, feeling of general exhaustion, slow gait, low level of physical activity or muscular weakness. A point will be assigned to each positive criterion. A final score formed by the sum of the five criteria. According to this score, subjects will be classified as follows:
- Non-frail: 0 points
- Pre-frail: 1 or 2 points
- Frail: 3 or more points
STUDY DESIGN It is an experimental, prospective, controlled study. Patients will be recruited from a previous cohort performed at the General University Hospital of Valencia (CHGUV). This study was entitled "Muscular architecture study by ultrasound for the diagnosis of frail with correlation of clinical, physical and biochemical markers". The patients of this cohort will be contacted by telephone, where they will be proposed to participate in the present study. Patients that accept will be ask to undergo a muscle ultrasound. At that time those who meet the inclusion criteria and none of the exclusion criteria, will be presented with the option of participating in the targeted exercise intervention. The subjects will be divided into Group 1 (Exercise) or Group 2 (Control). Those who agree to participate will be given the informed consent, offering them the appropriate time to read it and resolve doubts about it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 65 and 95 years, be physically inactive (<150 min physical activity a week), meet 1 or more criteria of frailty according to Linda Fried criteria, signature of informed consent.
排除标准
- •Institutionalized patients, life expectancy of less than 6 months for any reason, hospital admission in the last 3 months for any reason; major surgery in the last 6 months before the start of the study, oncological patient with active treatment with chemotherapy or radiotherapy; neurological or musculoskeletal pathology that contraindicates physical activity in water; severe disability (score below 15 points on the Barthel scale); severe cardiovascular disease, psychotic disorder or severe cognitive impairment.
结局指标
主要结局
Muscle Architecture Improvement
时间窗: 14 weeks
Muscle measurement with ultrasound before and after the intervention
次要结局
未报告次要终点