Outcome of Exercise With a Towel in Elderly With Sarcopenia
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise with a towel
Home-based exercise
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia focused on measuring elderly, sarcopenia, strengthening exercise
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
Sites / Locations
- Wujia Senior Citizens activity Center of Kaohsiung City Government
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exercise with a towel
Home-based exercise
Arm Description
There are 30 old adults in this group who receives exercise program with a towel.
There are 30 old adults in this group who is suggested a home-based program focuses on walking activity at fast speed.
Outcomes
Primary Outcome Measures
Fat mass
Dual-energy X-ray absorptiometry is used for measuring fat mass.
Fat-free mass
Dual-energy X-ray absorptiometry is used for measuring fat-free mass.
Bone mineral density
Dual-energy X-ray absorptiometry is used for measuring bone mineral density.
Maximal grip strength
Handgrip dynamometer is used for measuring maximal grip strength.
Walking speed
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Timed up and go test
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
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
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
The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
Secondary Outcome Measures
Fat mass
Dual-energy X-ray absorptiometry is used for measuring fat mass
Fat mass
Dual-energy X-ray absorptiometry is used for measuring fat mass
Fat-free mass
Dual-energy X-ray absorptiometry is used for measuring fat-free mass
Fat-free mass
Dual-energy X-ray absorptiometry is used for measuring fat-free mass
Bone mineral density
Dual-energy X-ray absorptiometry is used for measuring bone mineral density
Bone mineral density
Dual-energy X-ray absorptiometry is used for measuring bone mineral density
Maximal grip strength
Handgrip dynamometer is used for measuring maximal grip strength.
Maximal grip strength
Handgrip dynamometer is used for measuring maximal grip strength.
Walking speed
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Walking speed
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Timed up and go test
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.
Timed up and go test
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
The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sitdown within 30 seconds.
Times of stand-up and sit-down within 30 seconds
The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sitdown within 30 seconds.
6 minutes walking test
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.
6 minutes walking test
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
The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
Berg balance test
The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
Full Information
NCT ID
NCT03258827
First Posted
July 18, 2017
Last Updated
July 16, 2018
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03258827
Brief Title
Outcome of Exercise With a Towel in Elderly With Sarcopenia
Official Title
Chang Gung Medical Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
elderly, sarcopenia, strengthening exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise with a towel
Arm Type
Experimental
Arm Description
There are 30 old adults in this group who receives exercise program with a towel.
Arm Title
Home-based exercise
Arm Type
Placebo Comparator
Arm Description
There are 30 old adults in this group who is suggested a home-based program focuses on walking activity at fast speed.
Intervention Type
Procedure
Intervention Name(s)
Exercise with a towel
Other Intervention Name(s)
Home-based exercise
Intervention Description
Exercise program composes with warm-up, strengthening exercise, cold-down, 60 minutes/time, 3 times/week. A towel is an important tool for exercise. Total duration of the program is 3 months.
Intervention Type
Procedure
Intervention Name(s)
Home-based exercise
Intervention Description
Home-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times. The total duration is 3 months.
Primary Outcome Measure Information:
Title
Fat mass
Description
Dual-energy X-ray absorptiometry is used for measuring fat mass.
Time Frame
Baseline
Title
Fat-free mass
Description
Dual-energy X-ray absorptiometry is used for measuring fat-free mass.
Time Frame
Baseline
Title
Bone mineral density
Description
Dual-energy X-ray absorptiometry is used for measuring bone mineral density.
Time Frame
Baseline
Title
Maximal grip strength
Description
Handgrip dynamometer is used for measuring maximal grip strength.
Time Frame
Baseline
Title
Walking speed
Description
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Time Frame
Baseline
Title
Timed up and go test
Description
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.
Time Frame
Baseline
Title
Times of stand-up and sit-down within 30 seconds
Description
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.
Time Frame
Baseline
Title
6 minutes walking test
Description
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.
Time Frame
Baseline
Title
Berg balance test
Description
The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Fat mass
Description
Dual-energy X-ray absorptiometry is used for measuring fat mass
Time Frame
Change between baseline and 3 month after training
Title
Fat mass
Description
Dual-energy X-ray absorptiometry is used for measuring fat mass
Time Frame
Change between baseline and 6 month after training
Title
Fat-free mass
Description
Dual-energy X-ray absorptiometry is used for measuring fat-free mass
Time Frame
Change between baseline and 3 month after training
Title
Fat-free mass
Description
Dual-energy X-ray absorptiometry is used for measuring fat-free mass
Time Frame
Change between baseline and 6 month after training
Title
Bone mineral density
Description
Dual-energy X-ray absorptiometry is used for measuring bone mineral density
Time Frame
Change between baseline and 3 month after training
Title
Bone mineral density
Description
Dual-energy X-ray absorptiometry is used for measuring bone mineral density
Time Frame
Change between baseline and 6 month after training
Title
Maximal grip strength
Description
Handgrip dynamometer is used for measuring maximal grip strength.
Time Frame
Change between baseline and 3 month after training
Title
Maximal grip strength
Description
Handgrip dynamometer is used for measuring maximal grip strength.
Time Frame
Change between baseline and 6 month after training
Title
Walking speed
Description
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Time Frame
Change between baseline and 3 month after training
Title
Walking speed
Description
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Time Frame
Change between baseline and 6 month after training
Title
Timed up and go test
Description
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.
Time Frame
Change between baseline and 3 month after training
Title
Timed up and go test
Description
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.
Time Frame
Change between baseline and 6 month after training
Title
Times of stand-up and sit-down within 30 seconds
Description
The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sitdown within 30 seconds.
Time Frame
Change between baseline and 3 month after training
Title
Times of stand-up and sit-down within 30 seconds
Description
The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sitdown within 30 seconds.
Time Frame
Change between baseline and 6 month after training
Title
6 minutes walking test
Description
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.
Time Frame
Change between baseline and 3 month after training
Title
6 minutes walking test
Description
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.
Time Frame
Change between baseline and 6 month after training
Title
Berg balance test
Description
The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
Time Frame
Change between baseline and 3 month after training
Title
Berg balance test
Description
The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
Time Frame
Change between baseline and 6 month after training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shui Tseng
Organizational Affiliation
Chang Gung Medical Foundation Institutional Review Board
Official's Role
Study Chair
Facility Information:
Facility Name
Wujia Senior Citizens activity Center of Kaohsiung City Government
City
Kaohsiung
ZIP/Postal Code
830
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Outcome of Exercise With a Towel in Elderly With Sarcopenia
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