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临床试验/NCT04598464
NCT04598464
已完成
不适用

Effect of Home-Based Exercise Program on Physical Function and Balance in Older Adults With Sarcopenia: A Multicenter Randomized Controlled Study

Istanbul University5 个研究点 分布在 1 个国家目标入组 100 人2018年3月1日
适应症Sarcopenia

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Sarcopenia
发起方
Istanbul University
入组人数
100
试验地点
5
主要终点
Change from baseline timed up and go test at 3-months
状态
已完成
最后更新
5年前

概览

简要总结

In the prospective, randomized, controlled multi-centre study, 100 patients who were clinically diagnosed with sarcopenia were assigned to either a home-based exercise group or the control group. The home-based exercise program was performed three days per week for 12 weeks. Before and three months after the exercise program, all the patients were evaluated.

详细描述

Sarcopenia is a complex and multifactorial syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength.The randomized, multicenter study was conducted at the physical medicine and rehabilitation departments of five different centers. One hundred patients met the inclusion and exclusion criteria and were randomly allocated to either a home-based exercise group (n=50) or a control group (n=50). The patients were evaluated before and 3 months after inclusion using the timed up and go test, the Berg balance scale, the 6-minute walk test , a numeric rating scale to determine QoL, and the number of falls.

注册库
clinicaltrials.gov
开始日期
2018年3月1日
结束日期
2019年1月1日
最后更新
5年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Ekin Ilke Sen

Assistant Professor

Istanbul University

入排标准

入选标准

  • community-dwelling older adult diagnosis of sarcopenia according to the clinical examination; and able to walk independently. The physical performance of patients with a SARC-F score ≥4 were tested using a gait speed test and a short physical performance battery (SPPB). The diagnosis of sarcopenia was confirmed in cases where the patient's gait speed was ≤0.8 m/s and the SPPB score was ≤8

排除标准

  • having cardiovascular, pulmonary, and/or chronic diseases that may affect participation in the exercise program; impaired cognition; previous diagnosis of a neurological condition that severely affected mobility and balance; malignancy; metastatic cancer; serious vision loss or vestibular impairment

结局指标

主要结局

Change from baseline timed up and go test at 3-months

时间窗: Baseline, 3-month

The timed up and go test test measures the amount of time needed for a patient to stand up from a chair, walk three meters as quickly and safely as possible toward a cone, walk around it, and sit down on the chair again.

次要结局

  • Change from baseline 6-minute walk test (6MWT) at 3-months(Baseline, 3-month)
  • Change from baseline Berg balance scale score at 3-months(Baseline, 3-month)
  • Change from baseline self-reported QoL at 3-months(Baseline, 3-month)
  • Change from baseline number of falls at 3-months(Baseline, 3-month)

研究点 (5)

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