Protocol of Geriatric Rehabilitation in Patients of 60 and Older Who Live in Moscow Boarding Houses or Nursing Homes (POSTSCRIPTUM)

POSTSCRIPTUM: Protocol of Geriatric Rehabilitation in Patients of 60 and Older Who Live in Moscow Boarding Houses or Nursing Homes. Protocol of Multicentral Prospective Study.

After screening complex geriatric assessment (CGA) the participants will undergo geriatric rehabilitation programs. After termination of 21-day program, CGA will be repeated and subjects will get a program of long-term rehabilitation. A phone call in six months and a face-to-face visit in 12 months will be scheduled to follow-up and to evaluate the progress in rehabilitation.

Study Overview

Status

Completed

Detailed Description

After screening complex geriatric assessment (CGA) the participants will undergo geriatric rehabilitation programs. The participation duration will not exceed 13.5 months including the screening period.

The study comprises three periods:

  • screening (1-14 days)
  • a treatment course of 21 days
  • a follow-up period of 12 months On screening visit Study procedures will include
  • Informed consent signing
  • The Comprehensive Geriatric Assessment (CGA)
  • The recommendations on a program of geriatric rehabilitation based on CGA

Visit 2 will be performed at the end of rehabilitation program. It will include:

  • The abbreviated CGA
  • The evaluation of the results of 21-days geriatric rehabilitation program
  • The recommendations on a long-term geriatric rehabilitation

Visit 3 will be scheduled in 3 months after Visit 2 as a phone call. Special questionnaire will be suggested to study subjects. The questionnaire includes questions on implementation of a geriatric rehabilitation program and on quality of life

Visit 4- the last study visit will be performed in 12 months after Visit 2. It will include CGA and study completion procedures.

Study Type

Observational

Enrollment (Actual)

420

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

      • Moscow, Russian Federation, 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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

men and women aged 60 years and older eligible for geriatric rehabilitation, who were addmited to one of the study sites

Description

Inclusion Criteria:

  1. Men and women aged 60 and older who wanted to participate in the study and signed a consent form.
  2. One or more indications for geriatric rehabilitation:

    • A discharge after a hospitalization due to an acute illness (excluding stroke and myocardial infarction), trauma, surgery, including planned ones.
    • A condition leading to an acute impairment of functional status (stress, etc.)
    • Newly admitted patients
    • Abnormalities of gait and mobility (R26)

Exclusion Criteria:

  1. One or more contraindications to geriatric rehabilitation:

    1. Severe sensory and cognitive impairment hampering rehabilitation
    2. End stage diseases requiring palliative care
    3. End stage frailty (bedridden patients)
  2. An acute illness or an exacerbation of a chronic disease during two weeks before the enrollment in the study
  3. A contradiction to any component of a rehabilitation program
  4. Hearing or visual lost that can influence on study tests results
  5. Refuse to participate 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Frail elderly subjects
Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA
Geriatric rehabilitation program based on CGA will be performed under physicians tight control for 21 days and will include physical activity, psychological training, diet correction, adaptation measures, polypragmasia correction.
Pre-Frail elderly subjects
Pre-Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA
Geriatric rehabilitation program based on CGA will be performed under physicians tight control for 21 days and will include physical activity, psychological training, diet correction, adaptation measures, polypragmasia correction.
Non-frail elderly Frail subjects
Non-frail Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA
Geriatric rehabilitation program based on CGA will be performed under physicians tight control for 21 days and will include physical activity, psychological training, diet correction, adaptation measures, polypragmasia correction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional status dynamics
Time Frame: 13 months
Instrumental Activity Daily Life scale score
13 months

Collaborators and Investigators

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

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)

August 21, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2021/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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