Development of Frailty Prevention Clinic in Geriatric Comprehensive Clinic RSCM:

NCT05511311 | Unknown DMC

• 1 other identifier: Frailty Clinic
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Sarcopenia; Resistance Training

Keywords

frailty; sarcopenia; elderly; resistance training

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Walking Speed

  \<1.0 m/s

  12 weeks

• Patient's Quality of Life

  Measured by EQ-5D: ranging from 0 ('worst imaginable health') to 100 ('best imaginable health')

  12 weeks

Secondary Outcomes (2)

• Prevalence of Frailty

  12 weeks

• Prevalence of Sarcopenia

  12 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

12-week of Standard Therapy using elastic-band

Procedure: Standard Therapy

Intervention

EXPERIMENTAL

12-week of Resistance Training developed by RSCM using sand-bag

Procedure: Resistance Training

Interventions

Resistance Training PROCEDURE

Resistance training developed by the researcher (SCR-RSCM) for 12 weeks

Intervention

Standard Therapy PROCEDURE

Standard therapy for 12 weeks

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo National Hospital

Jakarta, Jakarta Pusat, 10310, Indonesia

RECRUITING

Related 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 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.

  PMID: 32033882 RESULT

• 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.

  PMID: 31383826 RESULT

• 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.

  PMID: 30312372 RESULT

MeSH Terms

Conditions

Frailty; Sarcopenia

Interventions

Resistance Training; Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 22, 2022
• Study Start: January 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

ID (1)