Frailty Level Monitoring and Analysis After a Pilot Six-week Randomized Controlled Clinical Trial Using FRED Exergame Including Biofeeback Supervision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- The Short Physical Performance Battery (SPPB)
研究概览
简要总结
A pilot six-week randomised controlled trial was carried out introducing biofeedback with physiological constants as follows: systolic blood pressure, diastolic blood pressure, heart rate and blood oxygen saturation in the intervention group.
详细描述
Objectives:
The main objectives are as follows:
- Verify that the risk of frailty has decreased upon completion of the ExerGame protocol.
- Assess the safety and cardiac healthiness of the exercises done using FRED.
Subject Recruitment Methods:
Contact was established with two residential homes for elderly people, and the necessary permits were requested and obtained from the management at the residential homes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •persons over 65 years of age with a Barthel score equal to or above 90 points who carry out no scheduled physical activity.
排除标准
- •persons over 65 years of age with a Barthel score less than 90 points or with a Barthel score equal to or above 90 points who carry out scheduled physical activity.
研究组 & 干预措施
study group / control group
The subjects belonging to the study group carried out three sessions per week over a 6-week period. Each session involved 20 minutes of activity divided into three parts.
The subjects belonging to the control group continued to lead their daily lives in the course of which they had no physical activity scheduled.
干预措施: FRED EXERGAME (Other)
结局指标
主要结局
The Short Physical Performance Battery (SPPB)
时间窗: 10min
This Battery includes 3 tests: balance test, gait speed and standing up from/sitting down on a chair 5 times. These tests follow a hierarchical sequence. A total score is obtained for the whole battery, which is the sum of that obtained from the 3 tests and ranges between 0 and 12, with scores below 10 evidencing frailty.
Barthel Index
时间窗: 10min
A scale with which a quantitative estimate is obtained of the degree of independence a subject has to pursue activities of daily living. The score ranges 0-100.
EuroQol 5D-5L
时间窗: 10 min
A standardised measure for state of health developed by the EuroQol Group in order to provide a single, general measurement applicable to a wide range of health conditions and treatments, which in turn provides a single descriptive profile and a unique state of health rate that may be used in clinical assessment . The individual themselves assesses their state of health - first in terms of seriousness via dimensions (descriptive system) and then via a visual analogue scale (VAS) for more general assessment purposes.
Systolic blood pressure
时间窗: 5 min
Systolic blood pressure was recorded. Reference value: \<150mmHg.
The System Usability Scale (SUS)
时间窗: 10 min
A questionnaire based on the Likert scale to rate the capacity for using systems. The score may be between 0 and 100, in which 100 represents the best usability and a score of ≥68 is considered positive.
Diastolic blood pressure
时间窗: 5 min
Diastolic blood pressure was recorded. Reference value: \<90mmHg.
Heart Rate
时间窗: 2 min
Heart rate was recorded. Reference value: \<76% Maximum heart rate.
Blood Oxygen Saturation
时间窗: 2 min
Blood oxygen saturation was recorded. Reference value: Variations \<5%SpO2.
次要结局
未报告次要终点
研究者
Begoña Garcia Zapirain
PI of eVIDA Research Group
University of Deusto