Outcome of Exercise With a Towel in Elderly With Sarcopenia

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: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Procedure: Exercise with a towel; Procedure: Home-based 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: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Fat mass	Dual-energy X-ray absorptiometry is used for measuring fat mass.	Baseline
Fat-free mass	Dual-energy X-ray absorptiometry is used for measuring fat-free mass.	Baseline
Bone mineral density	Dual-energy X-ray absorptiometry is used for measuring bone mineral density.	Baseline
Maximal grip strength	Handgrip dynamometer is used for measuring maximal grip strength.	Baseline
Walking speed	Participants are asked to walk at a comfortable speed to perform 10 meter walk test.	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.	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.	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.	Baseline
Berg balance test	The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat mass	Dual-energy X-ray absorptiometry is used for measuring fat mass	Change between baseline and 3 month after training
Fat mass	Dual-energy X-ray absorptiometry is used for measuring fat mass	Change between baseline and 6 month after training
Fat-free mass	Dual-energy X-ray absorptiometry is used for measuring fat-free mass	Change between baseline and 3 month after training
Fat-free mass	Dual-energy X-ray absorptiometry is used for measuring fat-free mass	Change between baseline and 6 month after training
Bone mineral density	Dual-energy X-ray absorptiometry is used for measuring bone mineral density	Change between baseline and 3 month after training
Bone mineral density	Dual-energy X-ray absorptiometry is used for measuring bone mineral density	Change between baseline and 6 month after training
Maximal grip strength	Handgrip dynamometer is used for measuring maximal grip strength.	Change between baseline and 3 month after training
Maximal grip strength	Handgrip dynamometer is used for measuring maximal grip strength.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Change between baseline and 6 month after training

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: elderly; sarcopenia; strengthening exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID 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