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Clinical and Functional Effectiveness Assessment of Personalized Management Programs for Patients With Frailty

All participants underwent comprehensive geriatric assessment (CGA) and cardiopulmonary exercise testing (CPET). A personalized management program was developed for each patient, including recommendations on physical exercise, nutrition, correction of geriatric syndromes, optimization of somatic status, and medication therapy adjustment. The program was delivered in a hospital setting over 3-5 days, with recommendations provided for continuation at the outpatient stage for 6 months. Upon completion of the 6-month program, CGA and CPET were repeated to evaluate the effectiveness of the programs.

研究概览

详细说明

All participants underwent comprehensive geriatric assessment (CGA) and cardiopulmonary exercise testing (CPET). After this the participants will undergo geriatric rehabilitation programs. The participation duration will not exceed 6.5 months including the screening period.

The study comprises three periods:

  • screening (1-14 days)
  • a treatment course of 3-5 days
  • a follow-up period of 6 months On screening visit Study procedures will include
  • Informed consent signing
  • The Comprehensive Geriatric Assessment (CGA)
  • Cardiopulmonary exersize test (CPET)
  • The recommendations on a program of geriatric rehabilitation based on CGA and CPET

The inpatient phase will last 3-5 days and will include:

  • Implementation of the comprehensive personalized management program
  • Issuance of recommendations for continuing the program at the outpatient stage Patients will be randomized into active follow-up and passive follow-up groups based on the number of scheduled telephone contacts using a specially designed structured questionnaire. Active follow-up group: short version of the telephone contact every 1 month during the first three months, with the full version at 3 months. Passive follow-up group: full version of the telephone contact at 3 months. The total duration of the outpatient follow-up phase will be 6 months.

Final visit will be performed at the end of rehabilitation program. It will include:

  • The CGA and CPET
  • The evaluation of the results of 6 months geriatric rehabilitation program
  • The recommendations on a long-term geriatric rehabilitation

研究类型

介入性

注册 (估计的)

115

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Moscow、俄罗斯、129226
        • Russian Research and Clinical Center for Gerontology

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

1. Men and women aged 60 and older who wanted to participate in the study and signed a consent form.

Exclusion Criteria:

  1. Presence of acute diseases or exacerbation of chronic diseases within 2 weeks prior to study inclusion.
  2. Presence of active malignant oncological diseases.
  3. Presence of severe cognitive impairment (dementia) and sensory deficits that may affect the ability to perform or evaluate study procedures.
  4. Presence of anemia (hemoglobin level <110 g/L).
  5. Presence of musculoskeletal disorders or peripheral artery disease that may affect mobility and the ability to undergo study procedures.
  6. Presence of one or more contraindications to exercise testing.
  7. Any other condition that, in the investigator's opinion, may preclude the patient's participation in the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Frailty
Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET
Geriatric rehabilitation program based on CGA and CPET will be performed under physicians' tight control over 3-5 days, followed by outpatient continuation for 6 months. After 6 months, CGA and CPET will be repeated to evaluate program effectiveness.
实验性的:Prefrailty
Pre-Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET
Geriatric rehabilitation program based on CGA and CPET will be performed under physicians' tight control over 3-5 days, followed by outpatient continuation for 6 months. After 6 months, CGA and CPET will be repeated to evaluate program effectiveness.
实验性的:Robust
Non-frail Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET
Geriatric rehabilitation program based on CGA and CPET will be performed under physicians' tight control over 3-5 days, followed by outpatient continuation for 6 months. After 6 months, CGA and CPET will be repeated to evaluate program effectiveness.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
functional status dynamics
大体时间:6 months
Instrumental and Basic Activity Daily Life scale score
6 months
Change in aerobic exercise capacity
大体时间:6 months
eak oxygen uptake (VO₂ peak) measured during cardiopulmonary exercise testing (CPET)
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Olga N Tkacheva, Dr.、Pirogov Russian National Research Medical University, the Russian Research and Clinical Center for Gerontology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月14日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年4月1日

研究注册日期

首次提交

2026年5月28日

首先提交符合 QC 标准的

2026年5月28日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月28日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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