Clinical and Functional Effectiveness Assessment of Personalized Management Programs for Patients With Frailty

NCT07623694 | Active Not Recruiting

• 1 other identifier: CPET/GR
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

All participants underwent comprehensive geriatric assessment (CGA) and cardiopulmonary exercise testing (CPET). A personalized management program was developed for each patient, including recommendations on physical exercise, nutrition, correction of geriatric syndromes, optimization of somatic status, and medication therapy adjustment. The program was delivered in a hospital setting over 3-5 days, with recommendations provided for continuation at the outpatient stage for 6 months. Upon completion of the 6-month program, CGA and CPET were repeated to evaluate the effectiveness of the programs.

Conditions

Frailty; Frailty/Sarcopenia

Keywords

geriatric rehabilitation; elderly; frailty; Complex geriatric assessment; Cardiopulmonary exercise testing

Outcome Measures

Primary Outcomes (2)

• functional status dynamics

  Instrumental and Basic Activity Daily Life scale score

  6 months

• Change in aerobic exercise capacity

  eak oxygen uptake (VO₂ peak) measured during cardiopulmonary exercise testing (CPET)

  6 months

Study Arms (3)

Frailty

EXPERIMENTAL

Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET

Other: Geriatric rehabilitation program based on CGA and CPET

Prefrailty

EXPERIMENTAL

Pre-Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET

Other: Geriatric rehabilitation program based on CGA and CPET

Robust

EXPERIMENTAL

Non-frail Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET

Other: Geriatric rehabilitation program based on CGA and CPET

Interventions

Geriatric rehabilitation program based on CGA and CPET OTHER

Geriatric rehabilitation program based on CGA and CPET will be performed under physicians' tight control over 3-5 days, followed by outpatient continuation for 6 months. After 6 months, CGA and CPET will be repeated to evaluate program effectiveness.

Frailty; Prefrailty; Robust

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: 60 years old and older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Men and women aged 60 and older who wanted to participate in the study and signed a consent form.

You may not qualify if:

• Presence of active malignant oncological diseases.
• Presence of severe cognitive impairment (dementia) and sensory deficits that may affect the ability to perform or evaluate study procedures.
• Presence of anemia (hemoglobin level \<110 g/L).
• Presence of musculoskeletal disorders or peripheral artery disease that may affect mobility and the ability to undergo study procedures.
• Presence of one or more contraindications to exercise testing.
• Any other condition that, in the investigator's opinion, may preclude the patient's participation in the study.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Russian Research and Clinical Center for Gerontology

Moscow, 129226, Russia

Location

MeSH Terms

Conditions

Frailty; Sarcopenia

Interventions

Clostridium perfringens epsilon-toxin

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

Study Officials

• Olga N Tkacheva, Dr.

  Pirogov Russian National Research Medical University, the Russian Research and Clinical Center for Gerontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: his is a prospective, non-randomized, parallel-group study. Participants are assigned to one of three final groups (Robust, Prefrailty, Frailty) based on a sequential algorithm using the questionnaire "Vozrast ne pomekha" (0-7 points) and the Short Physical Performance Battery (SPPB; 0-12 points): Step 1 - Questionnaire "Vozrast ne pomekha" score: \< 3 points → further stratified by SPPB: SPPB 10-12 → Robust SPPB 8-9 → Prefrailty SPPB ≤7 → Frailty 3-4 points → further stratified by SPPB: SPPB ≥8 → Prefrailty SPPB ≤7 → Frailty ≥ 5 points → Frailty (regardless of SPPB score)

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)