跳至主要内容
临床试验/NCT03258827
NCT03258827已完成不适用

Chang Gung Medical Hospital

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
Fat-free mass

研究概览

简要总结

As the proportion of older adults increases, elderly-related issues attract more attention. Sarcopenia is one of the popular elderly-related issues. Sarcopenia may induce decreased muscle strength, poor physical activity, even disability and increase rate of hospitalization and mortality. Therefore, we want to figure out the management for decreasing prevalence of sarcopenia in older adults. This trial is planned to perform during 2017/08/01~2017/12/31. We plan to enroll 60 elderlies who are sarcopenia. These patient will be divided into 2 group randomize. Experimental group will be received a set of exercise, composed by warm-up, strengthening training with a towel, cold-down, 60 minutes per time, 3 times per week. Control group will be suggested home-based walking activity. We will evaluate the patient's functional performance three times, before training, after training, post-training for three months, respectively. These results will be analyzed by repeated measure ANOVA.

详细描述

As the proportion of older adults increases, elderly-related issues attract more attention. Sarcopenia is one of the popular elderly-related issues. Skeletal muscle is an important component for sustaining physical activity and storing protein. Protein of skeletal muscle is used as energy substrates in cases of starvation or under stress. As being aging, physical condition degenerates gradually. Older adults usually have multiple chronic diseases. Lesser physical function results in less physical activity. As a result, more muscle mass would be lost. In previous study, after the age of 50 year-old, muscle mass decreases 1-2% per year. The velocity of muscle mass decline increases after the age of 60 year-old. Sarcopenia may induce decreased muscle strength, poor physical activity, even disability and increase rate of hospitalization and mortality. Therefore, we want to figure out the management for decreasing prevalence of sarcopenia in older adults.

Exercise is an important method for preventing sarcopenia. In this study, we intend to design a set of exercise which is easily performed for older adults and also has preventing muscle mass loss effect. Towel is an important tool for exercise.

Duration to execute is during 2017/08/01~2017/12/31. We randomize these 60 older adults into 2 groups (experimental group and control group) and there are 30 older adults in each group. Those older adults are age above 65 year-old, have lower grip strength and slower walking speed. One assistant who doesn't know which group these older adults belonged to would record their basic information and is responsible for the evaluation. We will evaluate the older adults' functional performance three times, before training, after training, post-training for three months, respectively.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The assistant who doesn't know the group which patients belong to will evaluate the functional performance of the patients three times, such as before training, after training, post-training 3 months.

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age above 65 y/o
  • •low muscle mass (male<7.0 kg/m2, female<5.4kg/m2, tested by Dual energy X-ray Absorptiometry)
  • •with or without low grip strength (male< 26 kg, female <18 kg)
  • •with or without low walk speed (≤ 0.8 m/s).

排除标准

  • •cognitive impairment or can't follow order appropriately
  • •elderlies with medical problems that they can't perform the exercise program

研究组 & 干预措施

Exercise with a towel

Experimental

There are 30 old adults in this group who receives exercise program with a towel.

干预措施: Exercise with a towel (Procedure)

Home-based exercise

Placebo Comparator

There are 30 old adults in this group who is suggested a home-based program focuses on walking activity at fast speed.

干预措施: Home-based exercise (Procedure)

结局指标

主要结局

Fat-free mass

时间窗: Baseline

Dual-energy X-ray absorptiometry is used for measuring fat-free mass.

Bone mineral density

时间窗: Baseline

Dual-energy X-ray absorptiometry is used for measuring bone mineral density.

Maximal grip strength

时间窗: Baseline

Handgrip dynamometer is used for measuring maximal grip strength.

Timed up and go test

时间窗: Baseline

At first, the participant sits down. Then the participant would be asked to stand up, walk straight for 3 meters, turn around, go back to the chair and sit down. The duration of whole test would be measured.

Times of stand-up and sit-down within 30 seconds

时间窗: Baseline

The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sit-down within 30 seconds.

6 minutes walking test

时间窗: Baseline

At first, the participant sits down for a rest for 10 minutes. The participant would be asked to walk as longer distance as the participant can within 6 minutes.

Berg balance test

时间窗: Baseline

The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.

Fat mass

时间窗: Baseline

Dual-energy X-ray absorptiometry is used for measuring fat mass.

Walking speed

时间窗: Baseline

Participants are asked to walk at a comfortable speed to perform 10 meter walk test.

次要结局

  • Walking speed(Change between baseline and 6 month after training)
  • Fat mass(Change between baseline and 6 month after training)
  • Fat-free mass(Change between baseline and 6 month after training)
  • Times of stand-up and sit-down within 30 seconds(Change between baseline and 6 month after training)
  • Maximal grip strength(Change between baseline and 6 month after training)
  • 6 minutes walking test(Change between baseline and 6 month after training)
  • Bone mineral density(Change between baseline and 6 month after training)
  • Timed up and go test(Change between baseline and 6 month after training)
  • Berg balance test(Change between baseline and 6 month after training)
  • Fat mass(Change between baseline and 3 month after training)
  • Fat-free mass(Change between baseline and 3 month after training)
  • Bone mineral density(Change between baseline and 3 month after training)
  • Maximal grip strength(Change between baseline and 3 month after training)
  • Walking speed(Change between baseline and 3 month after training)
  • Timed up and go test(Change between baseline and 3 month after training)
  • Times of stand-up and sit-down within 30 seconds(Change between baseline and 3 month after training)
  • 6 minutes walking test(Change between baseline and 3 month after training)
  • Berg balance test(Change between baseline and 3 month after training)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验