Development of Frailty Prevention Clinic in Geriatric Comprehensive Clinic RSCM:

August 19, 2022 updated by: Siti Setiati, Indonesia University

Development of Frailty Prevention Clinic in Geriatric Comprehensive Clinic RSCM: The Role of Resistance Training as Sarcopenia and Frailty Management Towards Frailty Score, Sarcopenia Score, and Quality of Life

There is an increasing number of elderly population, not only in Indonesia, but also in the world. With increasing of age, there is also an increasing number of elderly with sarcopenia and frailty. Both of the diseases can lead to dependency, decrease quality of life, and morbidity. Besides nutrition, physical activity, especially resistance training is proven to be beneficial in improving sarcopenia and frailty condition.

Currently in Cipto Mangunkusumo National Hospital (RSCM), there is no comprehensive frailty prevention clinic in the geriatric inpatient clinics. This research can be the base of frailty and sarcopenia treatment in RSCM.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

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

  • Indonesia
    • Jakarta Pusat
      • Jakarta, Jakarta Pusat, Indonesia, 10310
        • Recruiting
        • Cipto Mangunkusumo National Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Siti Setiati, Prof
        • Sub-Investigator:
          • Ika Fitriana, MD
        • Sub-Investigator:
          • Rahmi Istanti

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 60 years old or orlder
  • Categorized as Pre-frail or Frail based on FRAIL criteria
  • Is not in routine physical activity in the past 3 months
  • Succeeded Mini Physical Performance Test with score 11 or more

Exclusion Criteria:

  • Cognitive Disturbance (Abbreviated Mental Test < 8)
  • Not consenting to join the trial

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
12-week of Standard Therapy using elastic-band
Procedure: Standard Therapy
Standard therapy for 12 weeks
Experimental: Intervention
12-week of Resistance Training developed by RSCM using sand-bag
Procedure: Resistance Training
Resistance training developed by the researcher (SCR-RSCM) for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty Status
Time Frame: 12 weeks
The FRAIL scale includes 5 components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight (10). Frail scale scores range from 0-5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status
12 weeks
Sarcopenia Status
Time Frame: 12 weeks

Measured using:

  • BIA: <7.0 kg/m2 in men and <5.7 kg/m2 in women
  • Five times sit to stand: ≥12 seconds
  • Hand-grip strength: <28 kg for men and <18 kg for women
12 weeks
Walking Speed
Time Frame: 12 weeks
<1.0 m/s
12 weeks
Patient's Quality of Life
Time Frame: 12 weeks
Measured by EQ-5D: ranging from 0 ('worst imaginable health') to 100 ('best imaginable health')
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Frailty
Time Frame: 12 weeks
The FRAIL scale includes 5 components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight (10). Frail scale scores range from 0-5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status
12 weeks
Prevalence of Sarcopenia
Time Frame: 12 weeks

Measured using:

  • BIA: <7.0 kg/m2 in men and <5.7 kg/m2 in women
  • Five times sit to stand: ≥12 seconds
  • Hand-grip strength: <28 kg for men and <18 kg for women
12 weeks

Collaborators and Investigators

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

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2022

Primary Completion (Anticipated)

October 31, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Frailty Clinic

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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