Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03258827
Other study ID # 201700238B0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date June 30, 2018

Study information

Verified date July 2017
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date June 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Taiwan Wujia Senior Citizens activity Center of Kaohsiung City Government Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fat mass Dual-energy X-ray absorptiometry is used for measuring fat mass. Baseline
Primary Fat-free mass Dual-energy X-ray absorptiometry is used for measuring fat-free mass. Baseline
Primary Bone mineral density Dual-energy X-ray absorptiometry is used for measuring bone mineral density. Baseline
Primary Maximal grip strength Handgrip dynamometer is used for measuring maximal grip strength. Baseline
Primary Walking speed Participants are asked to walk at a comfortable speed to perform 10 meter walk test. Baseline
Primary 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
Primary 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
Primary 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
Primary Berg balance test The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults. Baseline
Secondary Fat mass Dual-energy X-ray absorptiometry is used for measuring fat mass Change between baseline and 3 month after training
Secondary Fat mass Dual-energy X-ray absorptiometry is used for measuring fat mass Change between baseline and 6 month after training
Secondary Fat-free mass Dual-energy X-ray absorptiometry is used for measuring fat-free mass Change between baseline and 3 month after training
Secondary Fat-free mass Dual-energy X-ray absorptiometry is used for measuring fat-free mass Change between baseline and 6 month after training
Secondary Bone mineral density Dual-energy X-ray absorptiometry is used for measuring bone mineral density Change between baseline and 3 month after training
Secondary Bone mineral density Dual-energy X-ray absorptiometry is used for measuring bone mineral density Change between baseline and 6 month after training
Secondary Maximal grip strength Handgrip dynamometer is used for measuring maximal grip strength. Change between baseline and 3 month after training
Secondary Maximal grip strength Handgrip dynamometer is used for measuring maximal grip strength. Change between baseline and 6 month after training
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06287502 - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis N/A
Recruiting NCT05063279 - RELIEF - Resistance Training for Life N/A
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Recruiting NCT06143592 - Inspiratory Muscle Training on Balance, Falls and Diaphragm Thickness in the Elderly N/A
Terminated NCT04350762 - Nutritional Supplementation in the Elderly With Weight Loss N/A
Enrolling by invitation NCT05953116 - Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health Study N/A
Recruiting NCT04028206 - Resistance Exercise or Vibration With HMB for Sarcopenia N/A
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A
Completed NCT03234920 - Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation After Liver Transplantation N/A
Recruiting NCT03998202 - Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Recruiting NCT04717869 - Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
Completed NCT05497687 - Strength-building Lifestyle-integrated Intervention N/A
Completed NCT03119610 - The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity Phase 1/Phase 2
Recruiting NCT05711095 - The Anabolic Properties of Fortified Plant-based Protein in Older People N/A
Recruiting NCT05008770 - Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Recruiting NCT04545268 - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance N/A
Recruiting NCT04522609 - Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant N/A
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease