- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03650907
Exercise Intervention for Patients With Sarcopenia or Frailty in Long-term Care Institutions
Sarcopenia is a geriatric syndrome of decreased muscle volume with muscular function decline. There is more tendency for sarcopenic elderly to be frail, disabled, or have cardiovascular disease. Compared to those who are not sarcopenic, they also had worse prognosis in response to treatment for definite diseases, and spend more medical cost.
Exercise appears to have an important role in management of sarcopenia. In the current study, the investigators provide an exercise program, including resistance/balance training for the elderly with sarcopenia or frailty in long-term care institution, and evaluate the effect.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Keelung, Taiwan, 205
- Bor-Ay Sweet home
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- >20-year-old
- diagnosed with sarcopenia (by the definition from Asia workgroup for sarcopenia, AWGS) or frailty (The Fried model, based on five functional criteria)
Exclusion Criteria:
- Severe medical diseases or mental problems, which result in difficulty to follow exercise program.
- Inability to get down from bed for activity due to disease, such as neuropathy or orthopedic disease.
- High risk group for exercise program, such as those with unstable fracture or nonunion fracture.
- Anyone who didn't want attend this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group exercise program by coach
|
Patients in experimental group attend group exercise program, instructed by fitness trainer, at long-term care institutions. Frequency: 3 times per week. Type: resistance/flexibility/balance training, including warm-up and cold-down. Duration: 1 hour per time, for 16 weeks. |
Sham Comparator: Self exercise
|
Patients in control group receive oral education for self exercise program, mainly resistance muscle training.
Patients are requested to do self-training for 16 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle strength
Time Frame: after 16-weeks training
|
grasp strength by dynamometer
|
after 16-weeks training
|
walk speed
Time Frame: after 16-weeks training
|
6-meter walk test
|
after 16-weeks training
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wen-Chun Tseng, Chang Gung Medical Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SarcExercise
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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