Exercise Intervention for Patients With Sarcopenia or Fra... | NCT03650907

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

NCT03650907

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Aug 13, 2019Actual

Enrollment

52Actual

Phase

Not Applicable

Conditions

Sarcopenia

Interventions

Group exercise program
Self exercise program

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2018Actual

Primary Completion Date

May 31, 2019Actual

Completion Date

May 31, 2019Actual

First Submitted Date

Aug 27, 2018

First Submission Date that Met QC Criteria

Aug 27, 2018

First Posted Date

Aug 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2019

Last Update Posted Date

Aug 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wen-Chun Tseng, Physiatrist, Physical Medicine and Rehabilitation, Principal Investigator, Chang Gung Memorial HospitalPrincipal Investigator

Lead Sponsor

Chang Gung Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group exercise program by coach	Experimental		Behavioral: Group exercise program
Self exercise	Sham Comparator		Behavioral: Self exercise program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group exercise program	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle strength	grasp strength by dynamometer	after 16-weeks training
walk speed	6-meter walk test	after 16-weeks training

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

110 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wen-Chun Tseng	Chang Gung Medical Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bor-Ay Sweet home		Keelung		205	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D055948	Sarcopenia

Ancestor Terms

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided