The Whole Body Vibration for Sarcopenic Hospitalized Patients Aged 80+ Years
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the whole body vibration
resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)
- Agree to participant this study and sign the informed consent
- Aged 80 years or over
Exclusion Criteria:
- Patients who could not follow the training plan due to cognitive impairment, emotional problems or any other reasons;
- Severe heart and lung diseases;
- Renal insufficiency;
- Any type of tumor;
- Bedridden patients
Sites / Locations
- West China Hospital,Sichuan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
controlled group
experimental group
Arm Description
Outcomes
Primary Outcome Measures
The change of activities of daily living
Basic activities of daily living (BADL) assessed by Barthel Index
Secondary Outcome Measures
The change of usual gait speed
The change of handgrip strength
The change of the score of Short Physical Performance Battery
The change of the score of Timed Up and Go test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04637789
Brief Title
The Whole Body Vibration for Sarcopenic Hospitalized Patients Aged 80+ Years
Official Title
Effectiveness of The Whole Body Vibration for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuxiang Liang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Resistance training have been recommended for sarcopenic patients. However, the whole body vibration training would further benefit for sarcopenic patients on the basis of resistance training remains unclear. The purpose of this study is to explore the effect of the whole body vibration training on improving the mobility of elderly patients with sarcopenia. The whole body vibration involves different frequencies that can improve muscle strength and keep aged upright, including the legs and core. These kinds of exercises can improve stability and help prevent falls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
controlled group
Arm Type
Other
Arm Title
experimental group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
the whole body vibration
Intervention Description
most people stand on the platform with knees bent at about a 30-degree angle, while the surface beneath their feet vibrates an astounding 30 times per second.
Intervention Type
Behavioral
Intervention Name(s)
resistance training
Intervention Description
Resistance training is a form of exercise that improves muscular strength and endurance. During a resistance training workout, you move your limbs against resistance provided by your body weight, gravity,bands, weighted bars or dumbbells.
Primary Outcome Measure Information:
Title
The change of activities of daily living
Description
Basic activities of daily living (BADL) assessed by Barthel Index
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
The change of usual gait speed
Time Frame
3 Months
Title
The change of handgrip strength
Time Frame
3 Months
Title
The change of the score of Short Physical Performance Battery
Time Frame
3 Months
Title
The change of the score of Timed Up and Go test
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
80 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)
Agree to participant this study and sign the informed consent
Aged 80 years or over
Exclusion Criteria:
Patients who could not follow the training plan due to cognitive impairment, emotional problems or any other reasons;
Severe heart and lung diseases;
Renal insufficiency;
Any type of tumor;
Bedridden patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ming Yang
Organizational Affiliation
West China Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
jiaojiao Jiang
Organizational Affiliation
West China Hospital
Official's Role
Study Director
Facility Information:
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610064
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Whole Body Vibration for Sarcopenic Hospitalized Patients Aged 80+ Years
We'll reach out to this number within 24 hrs