Development of Frailty Prevention Clinic in Geriatric Comprehensive Clinic RSCM:
Primary Purpose
Frailty, Sarcopenia, Resistance Training
Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Resistance Training
Standard Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Frailty focused on measuring frailty, sarcopenia, elderly, resistance training
Eligibility Criteria
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
Sites / Locations
- Cipto Mangunkusumo National HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Intervention
Arm Description
12-week of Standard Therapy using elastic-band
12-week of Resistance Training developed by RSCM using sand-bag
Outcomes
Primary Outcome Measures
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
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
Walking Speed
<1.0 m/s
Patient's Quality of Life
Measured by EQ-5D: ranging from 0 ('worst imaginable health') to 100 ('best imaginable health')
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05511311
Brief Title
Development of Frailty Prevention Clinic in Geriatric Comprehensive Clinic RSCM:
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Sarcopenia, Resistance Training
Keywords
frailty, sarcopenia, elderly, resistance training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
12-week of Standard Therapy using elastic-band
Arm Title
Intervention
Arm Type
Experimental
Arm Description
12-week of Resistance Training developed by RSCM using sand-bag
Intervention Type
Procedure
Intervention Name(s)
Resistance Training
Intervention Description
Resistance training developed by the researcher (SCR-RSCM) for 12 weeks
Intervention Type
Procedure
Intervention Name(s)
Standard Therapy
Intervention Description
Standard therapy for 12 weeks
Primary Outcome Measure Information:
Title
Frailty Status
Description
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
Time Frame
12 weeks
Title
Sarcopenia Status
Description
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
Time Frame
12 weeks
Title
Walking Speed
Description
<1.0 m/s
Time Frame
12 weeks
Title
Patient's Quality of Life
Description
Measured by EQ-5D: ranging from 0 ('worst imaginable health') to 100 ('best imaginable health')
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Prevalence of Frailty
Description
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
Time Frame
12 weeks
Title
Prevalence of Sarcopenia
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cipto Mangunkusumo National Hospital
City
Jakarta
State/Province
Jakarta Pusat
ZIP/Postal Code
10310
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siti Setiati, Prof
Phone
081389835588
Email
s_setiati@yahoo.com
First Name & Middle Initial & Last Name & Degree
Rahmi Istanti
Phone
081519745728
Email
rahmiistanti77@gmail.com
First Name & Middle Initial & Last Name & Degree
Siti Setiati, Prof
First Name & Middle Initial & Last Name & Degree
Ika Fitriana, MD
First Name & Middle Initial & Last Name & Degree
Rahmi Istanti
12. IPD Sharing Statement
Citations:
PubMed Identifier
32033882
Citation
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 Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
Results Reference
result
PubMed Identifier
31383826
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 Sarcopenia's Diagnostic Standard. Acta Med Indones. 2019 Apr;51(2):117-127.
Results Reference
result
PubMed Identifier
30312372
Citation
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere 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 People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. Erratum In: Age Ageing. 2019 Jul 1;48(4):601.
Results Reference
result
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