A Short-term Mixed Exercise for Sarcopenic Hospitalized Aged 80+ Years
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
balance training
resistance training
aerobic exercise
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- aged ≥80 years;
- being able to ambulate (assistance was acceptable);
- being able to communicate and collaborate with the physiotherapist;
- with sarcopenia defined by the AWGS criteria ;
Exclusion Criteria:
- terminal illness;
- uncontrolled heart failure;
- myocardial infarction within the past three months;
- uncontrolled respiratory failure;
- bone fractures within the past three months;
- acute pulmonary embolism;
- major surgery within the past three months;
- uncontrolled arrhythmia;
- refusal to participate in this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention group
control group
Arm Description
a mixed exercise program including aerobic, balance, and resistance exercises that were personally tailored.
usual care
Outcomes
Primary Outcome Measures
The change of activities of daily living from the baseline to the end of the 2-week intervention
Basic activities of daily living (BADL) assessed by Barthel Index. The total score for Barthel Index ranges from 0 (worst) to 100 (best) points.
Secondary Outcome Measures
The change of gait speed
Gait speed was measured using a 4-meter walking test.
The change of handgrip strength
Handgrip strength was measured using a digital grip dynamometer
The change of the score of Short Physical Performance Battery
The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The total score for SPPB ranges from 0 (worst) to 12 (best) points.
The change of the score of Timed Up and Go test
The Timed Up and Go test (TUG) is a simple test used to measure basic functional mobility and safety with mobility. The score for the TUG is the time consumption of the whole process. The longer time consuption indicates the more worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04355299
Brief Title
A Short-term Mixed Exercise for Sarcopenic Hospitalized Aged 80+ Years
Official Title
Effectiveness of a Short-term Mixed Exercise Program for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
January 1, 2020 (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
Most previous clinical trials that addressed exercise for sarcopenic elderly subjects focused on community-dwelling older adults who were relatively healthy. There is a notable paucity of high-quality research investigating the effects and feasibility of exercise for hospitalized or institutionalized older people, who are generally frailer and more severe in functional impairment than those living in the community. Moreover, most reported exercise programs were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term exercise would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of short-term exercise for treating sarcopenia in hospitalized older patients aged 80 years and over.
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
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
a mixed exercise program including aerobic, balance, and resistance exercises that were personally tailored.
Arm Title
control group
Arm Type
Other
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
balance training
Intervention Description
The training to improve balance is to work on the core muscle groups that help to maintain your posture.,and increase muscular strength.
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.
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention Description
Aerobic exercise is any activity that gets your blood pumping and large muscle groups working. It's also known as cardiovascular activity.
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
received usual care
Primary Outcome Measure Information:
Title
The change of activities of daily living from the baseline to the end of the 2-week intervention
Description
Basic activities of daily living (BADL) assessed by Barthel Index. The total score for Barthel Index ranges from 0 (worst) to 100 (best) points.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
The change of gait speed
Description
Gait speed was measured using a 4-meter walking test.
Time Frame
2 weeks
Title
The change of handgrip strength
Description
Handgrip strength was measured using a digital grip dynamometer
Time Frame
2 weeks
Title
The change of the score of Short Physical Performance Battery
Description
The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The total score for SPPB ranges from 0 (worst) to 12 (best) points.
Time Frame
2 weeks
Title
The change of the score of Timed Up and Go test
Description
The Timed Up and Go test (TUG) is a simple test used to measure basic functional mobility and safety with mobility. The score for the TUG is the time consumption of the whole process. The longer time consuption indicates the more worse outcome.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
80 Years
Maximum Age & Unit of Time
102 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged ≥80 years;
being able to ambulate (assistance was acceptable);
being able to communicate and collaborate with the physiotherapist;
with sarcopenia defined by the AWGS criteria ;
Exclusion Criteria:
terminal illness;
uncontrolled heart failure;
myocardial infarction within the past three months;
uncontrolled respiratory failure;
bone fractures within the past three months;
acute pulmonary embolism;
major surgery within the past three months;
uncontrolled arrhythmia;
refusal to participate in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiaojiao Jiang
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ming Yang
Organizational Affiliation
West China Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Short-term Mixed Exercise for Sarcopenic Hospitalized Aged 80+ Years
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