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Clinical Trials/NCT03258827
NCT03258827
Completed
N/A

Chang Gung Medical Hospital

Chang Gung Memorial Hospital1 site in 1 country53 target enrollmentSeptember 1, 2017
ConditionsSarcopenia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Chang Gung Memorial Hospital
Enrollment
53
Locations
1
Primary Endpoint
Maximal grip strength
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
June 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

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

Outcomes

Primary Outcomes

Maximal grip strength

Time Frame: Baseline

Handgrip dynamometer is used for measuring maximal grip strength.

Timed up and go test

Time Frame: 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

Time Frame: 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.

Fat-free mass

Time Frame: Baseline

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

Bone mineral density

Time Frame: Baseline

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

6 minutes walking test

Time Frame: 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

Time Frame: Baseline

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

Fat mass

Time Frame: Baseline

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

Walking speed

Time Frame: Baseline

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

Secondary Outcomes

  • 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)
  • Walking speed(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)

Study Sites (1)

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