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

August 9, 2019 updated by: Wen-Chun Tseng, Chang Gung Memorial Hospital

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

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Keelung, Taiwan, 205
        • Bor-Ay Sweet home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wen-Chun Tseng, Chang Gung Medical Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2018

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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