NCT03650907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

August 27, 2018

Last Update Submit

August 9, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Muscle strength

    grasp strength by dynamometer

    after 16-weeks training

  • walk speed

    6-meter walk test

    after 16-weeks training

Study Arms (2)

Group exercise program by coach

EXPERIMENTAL
Behavioral: Group exercise program

Self exercise

SHAM COMPARATOR
Behavioral: Self exercise program

Interventions

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.

Group exercise program by coach

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.

Self exercise

Eligibility Criteria

Age20 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bor-Ay Sweet home

Keelung, 205, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Wen-Chun Tseng

    Chang Gung Medical Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiatrist, Physical Medicine and Rehabilitation, Principal Investigator

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

August 24, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations