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Outcome of Exercise With a Towel in Elderly With Sarcopenia

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ClinicalTrials.gov Identifier: NCT03258827
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Procedure: Exercise with a towel Procedure: Home-based exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (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.
Primary Purpose: Treatment
Official Title: Chang Gung Medical Hospital
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Fat mass [ Time Frame: Baseline ]
    Dual-energy X-ray absorptiometry is used for measuring fat mass.

  2. Fat-free mass [ Time Frame: Baseline ]
    Dual-energy X-ray absorptiometry is used for measuring fat-free mass.

  3. Bone mineral density [ Time Frame: Baseline ]
    Dual-energy X-ray absorptiometry is used for measuring bone mineral density.

  4. Maximal grip strength [ Time Frame: Baseline ]
    Handgrip dynamometer is used for measuring maximal grip strength.

  5. Walking speed [ Time Frame: Baseline ]
    Participants are asked to walk at a comfortable speed to perform 10 meter walk test.

  6. 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.

  7. 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.

  8. 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.

  9. 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.


Secondary Outcome Measures :
  1. Fat mass [ Time Frame: Change between baseline and 3 month after training ]
    Dual-energy X-ray absorptiometry is used for measuring fat mass

  2. Fat mass [ Time Frame: Change between baseline and 6 month after training ]
    Dual-energy X-ray absorptiometry is used for measuring fat mass

  3. 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

  4. 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

  5. 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

  6. 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

  7. Maximal grip strength [ Time Frame: Change between baseline and 3 month after training ]
    Handgrip dynamometer is used for measuring maximal grip strength.

  8. Maximal grip strength [ Time Frame: Change between baseline and 6 month after training ]
    Handgrip dynamometer is used for measuring maximal grip strength.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258827


Locations
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Taiwan
Wujia Senior Citizens activity Center of Kaohsiung City Government
Kaohsiung, Taiwan, 830
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Shui Tseng Chang Gung Medical Foundation Institutional Review Board
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03258827    
Other Study ID Numbers: 201700238B0
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
elderly
sarcopenia
strengthening exercise
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical