Clinical trial NCT03258827: Outcome of Exercise With a Towel in Elderly With Sarcopenia
Official title: Chang Gung Medical Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: elderly
sarcopenia
strengthening exercise
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 53
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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. Experimental group receive this exercise program training, 60 minutes/time, 3 times/week, total duration: 3 months. Home-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times, would be assigned for Control group. Total duration is 3 months.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Fat mass
timeFrame: Baseline
measure: Fat-free mass
timeFrame: Baseline
measure: Bone mineral density
timeFrame: Baseline
measure: Maximal grip strength
timeFrame: Baseline
measure: Walking speed
timeFrame: Baseline
measure: Timed up and go test
timeFrame: Baseline
measure: Times of stand-up and sit-down within 30 seconds
timeFrame: Baseline
measure: 6 minutes walking test
timeFrame: Baseline
measure: Berg balance test
timeFrame: Baseline
Secondary outcomes:
measure: Fat mass
timeFrame: Change between baseline and 3 month after training
measure: Fat mass
timeFrame: Change between baseline and 6 month after training
measure: Fat-free mass
timeFrame: Change between baseline and 3 month after training
measure: Fat-free mass
timeFrame: Change between baseline and 6 month after training
measure: Bone mineral density
timeFrame: Change between baseline and 3 month after training
measure: Bone mineral density
timeFrame: Change between baseline and 6 month after training
measure: Maximal grip strength
timeFrame: Change between baseline and 3 month after training
measure: Maximal grip strength
timeFrame: Change between baseline and 6 month after training
measure: Walking speed
timeFrame: Change between baseline and 3 month after training
measure: Walking speed
timeFrame: Change between baseline and 6 month after training
measure: Timed up and go test
timeFrame: Change between baseline and 3 month after training
measure: Timed up and go test
timeFrame: Change between baseline and 6 month after training
measure: Times of stand-up and sit-down within 30 seconds
timeFrame: Change between baseline and 3 month after training
measure: Times of stand-up and sit-down within 30 seconds
timeFrame: Change between baseline and 6 month after training
measure: 6 minutes walking test
timeFrame: Change between baseline and 3 month after training
measure: 6 minutes walking test
timeFrame: Change between baseline and 6 month after training
measure: Berg balance test
timeFrame: Change between baseline and 3 month after training
measure: Berg balance test
timeFrame: Change between baseline and 6 month after training
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Wujia Senior Citizens activity Center of Kaohsiung City Government
Study officials:
affiliation: Chang Gung Medical Foundation Institutional Review Board
name: Shui Tseng
role: STUDY_CHAIR
References: