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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07623694
Enrollment
115
Registered
2026-06-03
Start date
2026-04-14
Completion date
2027-04-01
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Frailty/Sarcopenia

Keywords

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

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.

Detailed description

All participants underwent comprehensive geriatric assessment (CGA) and cardiopulmonary exercise testing (CPET). After this the participants will undergo geriatric rehabilitation programs. The participation duration will not exceed 6.5 months including the screening period. The study comprises three periods: * screening (1-14 days) * a treatment course of 3-5 days * a follow-up period of 6 months On screening visit Study procedures will include * Informed consent signing * The Comprehensive Geriatric Assessment (CGA) * Cardiopulmonary exersize test (CPET) * The recommendations on a program of geriatric rehabilitation based on CGA and CPET The inpatient phase will last 3-5 days and will include: * Implementation of the comprehensive personalized management program * Issuance of recommendations for continuing the program at the outpatient stage Patients will be randomized into active follow-up and passive follow-up groups based on the number of scheduled telephone contacts using a specially designed structured questionnaire. Active follow-up group: short version of the telephone contact every 1 month during the first three months, with the full version at 3 months. Passive follow-up group: full version of the telephone contact at 3 months. The total duration of the outpatient follow-up phase will be 6 months. Final visit will be performed at the end of rehabilitation program. It will include: * The CGA and CPET * The evaluation of the results of 6 months geriatric rehabilitation program * The recommendations on a long-term geriatric rehabilitation

Interventions

OTHERGeriatric rehabilitation program based on CGA and CPET

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.

Sponsors

Pirogov Russian National Research Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. Presence of acute diseases or exacerbation of chronic diseases within 2 weeks prior to study inclusion. 2. Presence of active malignant oncological diseases. 3. Presence of severe cognitive impairment (dementia) and sensory deficits that may affect the ability to perform or evaluate study procedures. 4. Presence of anemia (hemoglobin level \<110 g/L). 5. Presence of musculoskeletal disorders or peripheral artery disease that may affect mobility and the ability to undergo study procedures. 6. Presence of one or more contraindications to exercise testing. 7. Any other condition that, in the investigator's opinion, may preclude the patient's participation in the study.

Design outcomes

Primary

MeasureTime frameDescription
functional status dynamics6 monthsInstrumental and Basic Activity Daily Life scale score
Change in aerobic exercise capacity6 monthseak oxygen uptake (VO₂ peak) measured during cardiopulmonary exercise testing (CPET)

Countries

Russia

Contacts

PRINCIPAL_INVESTIGATOROlga N Tkacheva, Dr.

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026