Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Osteoporosis (DHEAL-COM-OP)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement in physical performance
研究概览
简要总结
The DHEAL-COM-OP study is characterized as a feasibility study. The general objective is to evaluate the improvement in the physical performance of patients with osteoporosis detected through the Performance-Oriented Mobility Assessment (POMA) scale, following a rehabilitation intervention integrated with the BTS TELEREHAB technology.
详细描述
The DHEAL COM project aims to evaluate the improvement in physical performance of patients with osteoporosis following a rehabilitation intervention integrated with technology in telerehabilitation. Specifically, the project aims to develop a telerehabilitation platform that enables people to perform physical activity at home.
The first objective of the project is to evaluate the improvement of physical performance, in terms of gait and balance capability, of patients with osteoporosis detected through the Tinetti Performance Oriented Mobility Assessment (POMA) scale following an integrated rehabilitation intervention with BTS TELEREHAB technology.
Forty elderly people with osteoporosis aged at least 65 years who wish to participate in the study and who meet the inclusion and exclusion criteria. Participants will be randomized into experimental group (GS) and control group (GC). Patients in the experimental group will receive a personalized program of home tele-rehabilitation exercises divided into 3 workouts per week, for a duration of 12 weeks. The training sessions will be organized as follows: one session will be carried out in telerehabilitation with the support of the physiotherapist in small groups of maximum 5 patients; in the remaining two the patient will perform the exercises independently at home. Before starting the rehabilitation program, the patient will receive training with the technology in the hospital, in the presence of the physiotherapist.
Patients in the control group will be offered activities to perform at home, with the same frequency, in line with the usual care activities already proposed by the Rehabilitation Unit.
Patients will be contacted periodically by the physiotherapist to evaluate the improvement of the main and secondary outcomes detailed in the following protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (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
- 否
入选标准
- •Patients with a positive MOC for osteoporosis without a history of major fractures (femur and vertebrae);
- •Functional Ambulation Category (FAC) score ≥ 3;
- •Stability of drug treatment for at least 1 month;
- •Maintaining an upright position independently > 30";
- •Mini-Mental State Examination (MMSE) ≥ 24;
- •Geriatric depression scale (GDS) < 2;
排除标准
- •Myocardial infarction or stroke within 6 months;
- •Painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility;
- •Uncontrolled hypertension
- •Metastatic cancer or immunosuppressive therapy;
- •Significant visual or hearing impairment
结局指标
主要结局
Improvement in physical performance
时间窗: At baseline and 12 weeks later
The physical performance, in terms of balance and gait ability, will be detected through the Tinetti Performance Oriented Mobility Assessment (POMA) scale. The maximum possible score is 28 points. The total POMA score provides an indication of an individual's fall risk: * 25-28 points: Indicates a low risk of falls * 19-24 points: Indicates a medium or moderate risk of falls * Less than 19 points (\< 19): Indicates a high risk of falls The improvement is assessed in an increase in the POMA score of at least 3 points.
次要结局
- Improvement in physical function(At baseline and 12 weeks later)
- Improvement in quality of life(At baseline and 12 weeks later)
- Improvement in mobility(At baseline and 12 weeks later)