Development of Frailty Prevention Clinic in Geriatric Comprehensive Clinic RSCM:

• Sponsor: Indonesia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05511311
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.9
• Patients Per Site Per Month: 20.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty; Sarcopenia; Resistance Training	Procedure: Resistance Training; Procedure: Standard Therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Nov 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Frailty Status [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

2. Sarcopenia Status [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

3. Walking Speed [12 weeks]

   <1.0 m/s

4. Patient's Quality of Life [12 weeks]

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

Secondary Outcome Measures

1. Prevalence of Frailty [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

2. Prevalence of Sarcopenia [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo National Hospital	Jakarta	Jakarta Pusat	Indonesia	10310

Sponsors and Collaborators

• Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Siti Setiati, Prof, Indonesia University
• ClinicalTrials.gov Identifier: NCT05511311
• Other Study ID Numbers: Frailty Clinic
• First Posted: Aug 22, 2022
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Siti Setiati, Prof, Indonesia University: frailty; sarcopenia; elderly; resistance training
• Additional relevant MeSH terms: Sarcopenia; Frailty

Study Results

No Results Posted as of Aug 22, 2022