SarcopeniaNCT03258827
Outcome of Exercise With a Towel in Elderly With Sarcopenia
A study testing Exercise with a towel and Home-based exercise in people with Sarcopenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Exercise with a towel and Home-based exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- cognitive impairment or can't follow order appropriately
- elderlies with medical problems that they can't perform the exercise program
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Wujia Senior Citizens activity Center of Kaohsiung City Government
Kaohsiung City, 830
About this study
Official title: Chang Gung Medical Hospital
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Exercise with a towel, Home-based exercise
- Keywords
- elderly, sarcopenia, strengthening exercise
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with a towelProcedure or surgery
Also called Home-based exercise
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.
Home-based exerciseProcedure or surgery
Home-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times. The total duration is 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Exercise with a towel | Experimental | There are 30 old adults in this group who receives exercise program with a towel. Receives: Procedure: Exercise with a towel |
| 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. Receives: Procedure: Home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
Dual-energy X-ray absorptiometry is used for measuring fat mass.
Measured: Baseline
Fat-free mass
Dual-energy X-ray absorptiometry is used for measuring fat-free mass.
Measured: Baseline
Bone mineral density
Dual-energy X-ray absorptiometry is used for measuring bone mineral density.
Measured: Baseline
Maximal grip strength
Handgrip dynamometer is used for measuring maximal grip strength.
Measured: Baseline
Walking speed
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Berg balance test
The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
Measured: Baseline
Secondary outcomes (18)
Fat mass
Dual-energy X-ray absorptiometry is used for measuring fat mass
Measured: Change between baseline and 3 month after training
Fat mass
Dual-energy X-ray absorptiometry is used for measuring fat mass
Measured: Change between baseline and 6 month after training
Fat-free mass
Dual-energy X-ray absorptiometry is used for measuring fat-free mass
Measured: Change between baseline and 3 month after training
Fat-free mass
Dual-energy X-ray absorptiometry is used for measuring fat-free mass
Measured: Change between baseline and 6 month after training
Bone mineral density
Dual-energy X-ray absorptiometry is used for measuring bone mineral density
Measured: Change between baseline and 3 month after training
Bone mineral density
Dual-energy X-ray absorptiometry is used for measuring bone mineral density
Measured: Change between baseline and 6 month after training
Maximal grip strength
Handgrip dynamometer is used for measuring maximal grip strength.
Measured: Change between baseline and 3 month after training
Maximal grip strength
Handgrip dynamometer is used for measuring maximal grip strength.
Measured: Change between baseline and 6 month after training
Walking speed
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Measured: Change between baseline and 3 month after training
Walking speed
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Measured: Change between baseline and 6 month after training
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.
Measured: Change between baseline and 3 month after training
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.
Measured: Change between baseline and 6 month after training
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.
Measured: Change between baseline and 3 month after training
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.
Measured: Change between baseline and 6 month after training
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.
Measured: Change between baseline and 3 month after training
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.
Measured: Change between baseline and 6 month after training
Berg balance test
The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
Measured: Change between baseline and 3 month after training
Berg balance test
The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
Measured: Change between baseline and 6 month after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Sep 2017
- Primary completion30 Apr 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shui Tseng, Study chair, Chang Gung Medical Foundation Institutional Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258827
- Sponsor's protocol ID
- 201700238B0
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chang Gung Medical Hospital
- ClinicalTrials.gov ID
- NCT03258827
- Acronym / sponsor ID
- 201700238B0
- Conditions
- Sarcopenia
- Keywords
- elderly, sarcopenia, strengthening exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise with a towel | Experimental | Procedure: Exercise with a towelThere are 30 old adults in this group who receives exercise program with a towel. |
| Home-based exercise | Placebo comparator | Procedure: Home-based exerciseThere are 30 old adults in this group who is suggested a home-based program focuses on walking activity at fast speed. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- cognitive impairment or can't follow order appropriately
- elderlies with medical problems that they can't perform the exercise program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise with a towelAlso: Home-based exerciseExercise 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. | Procedure or surgery | Exercise with a towel |
| Home-based exerciseHome-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times. The total duration is 3 months. | Procedure or surgery | Home-based exercise |
Primary outcome
Fat mass
Time frame: Baseline
Dual-energy X-ray absorptiometry is used for measuring fat mass.
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.
Maximal grip strength
Time frame: Baseline
Handgrip dynamometer is used for measuring maximal grip strength.
Walking speed
Time frame: Baseline
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
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.
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.
18 secondary outcomes
Fat mass
Time frame: Change between baseline and 3 month after training
Fat mass
Time frame: Change between baseline and 6 month after training
Fat-free mass
Time frame: Change between baseline and 3 month after training
Fat-free mass
Time frame: Change between baseline and 6 month after training
Bone mineral density
Time frame: Change between baseline and 3 month after training
Bone mineral density
Time frame: Change between baseline and 6 month after training
Maximal grip strength
Time frame: Change between baseline and 3 month after training
Maximal grip strength
Time frame: Change between baseline and 6 month after training
Walking speed
Time frame: Change between baseline and 3 month after training
Walking speed
Time frame: Change between baseline and 6 month after training
Timed up and go test
Time frame: Change between baseline and 3 month after training
Timed up and go test
Time frame: Change between baseline and 6 month after training
Times of stand-up and sit-down within 30 seconds
Time frame: Change between baseline and 3 month after training
Times of stand-up and sit-down within 30 seconds
Time frame: Change between baseline and 6 month after training
6 minutes walking test
Time frame: Change between baseline and 3 month after training
6 minutes walking test
Time frame: Change between baseline and 6 month after training
Berg balance test
Time frame: Change between baseline and 3 month after training
Berg balance test
Time frame: Change between baseline and 6 month after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
RecruitingObservational study
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Colorectal Cancer, Sarcopenia
Active, not recruiting
Online Prehabilitation for Patients Awaiting Liver Transplantation
Cirrhosis, Liver, Liver Transplant Surgery
RecruitingObservational study
Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls
Primary Ciliary Dyskinesia (PCD)
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shui Tseng study chair
Chang Gung Medical Foundation Institutional Review Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with a towel and Home-based exercise in people with Sarcopenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.