Outcome of Exercise With a Towel in Elderly With Sarcopenia

July 16, 2018 updated by: Chang Gung Memorial Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 830
        • Wujia Senior Citizens activity Center of Kaohsiung City Government

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise with a towel
There are 30 old adults in this group who receives exercise program with a towel.
Procedure: Exercise with a towel
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.
Other Names:
  • Home-based exercise
Placebo Comparator: Home-based exercise
There are 30 old adults in this group who is suggested a home-based program focuses on walking activity at fast speed.
Procedure: Home-based exercise
Home-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times. The total duration is 3 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fat mass
Time Frame: Baseline
Dual-energy X-ray absorptiometry is used for measuring fat mass.
Baseline
Fat-free mass
Time Frame: Baseline
Dual-energy X-ray absorptiometry is used for measuring fat-free mass.
Baseline
Bone mineral density
Time Frame: Baseline
Dual-energy X-ray absorptiometry is used for measuring bone mineral density.
Baseline
Maximal grip strength
Time Frame: Baseline
Handgrip dynamometer is used for measuring maximal grip strength.
Baseline
Walking speed
Time Frame: Baseline
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fat mass
Time Frame: Change between baseline and 3 month after training
Dual-energy X-ray absorptiometry is used for measuring fat mass
Change between baseline and 3 month after training
Fat mass
Time Frame: Change between baseline and 6 month after training
Dual-energy X-ray absorptiometry is used for measuring fat mass
Change between baseline and 6 month after training
Fat-free mass
Time Frame: Change between baseline and 3 month after training
Dual-energy X-ray absorptiometry is used for measuring fat-free mass
Change between baseline and 3 month after training
Fat-free mass
Time Frame: Change between baseline and 6 month after training
Dual-energy X-ray absorptiometry is used for measuring fat-free mass
Change between baseline and 6 month after training
Bone mineral density
Time Frame: Change between baseline and 3 month after training
Dual-energy X-ray absorptiometry is used for measuring bone mineral density
Change between baseline and 3 month after training
Bone mineral density
Time Frame: Change between baseline and 6 month after training
Dual-energy X-ray absorptiometry is used for measuring bone mineral density
Change between baseline and 6 month after training
Maximal grip strength
Time Frame: Change between baseline and 3 month after training
Handgrip dynamometer is used for measuring maximal grip strength.
Change between baseline and 3 month after training
Maximal grip strength
Time Frame: Change between baseline and 6 month after training
Handgrip dynamometer is used for measuring maximal grip strength.
Change between baseline and 6 month after training
Walking speed
Time Frame: Change between baseline and 3 month after training
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Change between baseline and 3 month after training
Walking speed
Time Frame: Change between baseline and 6 month after training
Participants are asked to walk at a comfortable speed to perform 10 meter walk test.
Change between baseline and 6 month after training
Timed up and go test
Time Frame: Change between baseline and 3 month after training
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.
Change between baseline and 3 month after training
Timed up and go test
Time Frame: Change between baseline and 6 month after training
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.
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
The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sitdown within 30 seconds.
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
The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sitdown within 30 seconds.
Change between baseline and 6 month after training
6 minutes walking test
Time Frame: Change between baseline and 3 month after training
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.
Change between baseline and 3 month after training
6 minutes walking test
Time Frame: Change between baseline and 6 month after training
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.
Change between baseline and 6 month after training
Berg balance test
Time Frame: Change between baseline and 3 month after training
The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
Change between baseline and 3 month after training
Berg balance test
Time Frame: Change between baseline and 6 month after training
The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.
Change between baseline and 6 month after training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201700238B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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