Development of Frailty Prevention Clinic in Geriatric Comprehensive Clinic RSCM:

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05511311
• Other study ID #: Frailty Clinic
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: August 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Resistance Training
• Sarcopenia

Intervention

Procedure:
• Resistance Training
Resistance training developed by the researcher (SCR-RSCM) for 12 weeks
• Standard Therapy
Standard therapy for 12 weeks

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Hospital	Jakarta	Jakarta Pusat

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian — View Citation

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyère O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older Peopl — View Citation

Mienche M, Setiati S, Setyohadi B, Kurniawan J, Laksmi PW, Ariane A, Tirtarahardja G. Diagnostic Performance of Calf Circumference, Thigh Circumference, and SARC-F Questionnaire to Identify Sarcopenia in Elderly Compared to Asian Working Group for Sarcope — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty Status	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
Primary	Sarcopenia Status	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
Primary	Walking Speed	<1.0 m/s	12 weeks
Primary	Patient's Quality of Life	Measured by EQ-5D: ranging from 0 ('worst imaginable health') to 100 ('best imaginable health')	12 weeks
Secondary	Prevalence of Frailty	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
Secondary	Prevalence of Sarcopenia	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