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

May 28, 2026 updated by: Pirogov Russian National Research Medical University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Moscow, Russia, 129226
        • Russian Research and Clinical Center for Gerontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Frailty
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
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.
Experimental: Prefrailty
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
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.
Experimental: Robust
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional status dynamics
Time Frame: 6 months
Instrumental and Basic Activity Daily Life scale score
6 months
Change in aerobic exercise capacity
Time Frame: 6 months
eak oxygen uptake (VO₂ peak) measured during cardiopulmonary exercise testing (CPET)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pirogov Russian National Research Medical University

Investigators

  • Principal Investigator: Olga N Tkacheva, Dr., Pirogov Russian National Research Medical University, the Russian Research and Clinical Center for Gerontology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 28, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPET/GR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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