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Active, Not Recruiting

NCT Number: NCT07623694

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Russian Research and Clinical Center for Gerontology

Moscow, 129226, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Presence of acute diseases or exacerbation of chronic diseases within 2 weeks prior to study inclusion.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. functional status dynamics

    Time frame: 6 months

    Instrumental and Basic Activity Daily Life scale score

  2. Change in aerobic exercise capacity

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Pirogov Russian National Research Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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