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Exercise Intervention for Patients With Sarcopenia or Frailty in Long-term Care Institutions

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Group exercise program
Self exercise program
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

20 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. >20-year-old
  2. diagnosed with sarcopenia (by the definition from Asia workgroup for sarcopenia, AWGS) or frailty (The Fried model, based on five functional criteria)

Exclusion Criteria:

  1. Severe medical diseases or mental problems, which result in difficulty to follow exercise program.
  2. Inability to get down from bed for activity due to disease, such as neuropathy or orthopedic disease.
  3. High risk group for exercise program, such as those with unstable fracture or nonunion fracture.
  4. Anyone who didn't want attend this study.

Sites / Locations

  • Bor-Ay Sweet home

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Group exercise program by coach

Self exercise

Arm Description

Outcomes

Primary Outcome Measures

Muscle strength
grasp strength by dynamometer
walk speed
6-meter walk test

Secondary Outcome Measures

Full Information

First Posted
August 27, 2018
Last Updated
August 9, 2019
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03650907
Brief Title
Exercise Intervention for Patients With Sarcopenia or Frailty in Long-term Care Institutions
Official Title
Exercise Intervention for Patients With Sarcopenia or Frailty in Long-term Care Institutions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 24, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

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
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.

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
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group exercise program by coach
Arm Type
Experimental
Arm Title
Self exercise
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Group exercise program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle strength
Description
grasp strength by dynamometer
Time Frame
after 16-weeks training
Title
walk speed
Description
6-meter walk test
Time Frame
after 16-weeks training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Chun Tseng
Organizational Affiliation
Chang Gung Medical Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bor-Ay Sweet home
City
Keelung
ZIP/Postal Code
205
Country
Taiwan

12. IPD Sharing Statement

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Exercise Intervention for Patients With Sarcopenia or Frailty in Long-term Care Institutions

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