Protocol of Geriatric Rehabilitation in Patients of 60 an... | NCT05740436

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

NCT05740436

Sponsor

Pirogov Russian National Research Medical University

Status

Completed

Last Update Posted

Jun 13, 2025Actual

Enrollment

420Actual

Phase

Not provided

Conditions

Frail Elderly Syndrome

Interventions

Geriatric rehabilitation program based on CGA

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 21, 2021Actual

Primary Completion Date

Aug 31, 2023Actual

Completion Date

Aug 31, 2024Actual

First Submitted Date

Feb 13, 2023

First Submission Date that Met QC Criteria

Feb 13, 2023

First Posted Date

Feb 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2025

Last Update Posted Date

Jun 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

420Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Frail elderly subjects	Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA	Other: Geriatric rehabilitation program based on CGA
Pre-Frail elderly subjects	Pre-Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA	Other: Geriatric rehabilitation program based on CGA
Non-frail elderly Frail subjects	Non-frail Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA	Other: Geriatric rehabilitation program based on CGA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Geriatric rehabilitation program based on CGA	Other	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.

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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)
An acute illness or an exacerbation of a chronic disease during two weeks before the enrollment in the study
A contradiction to any component of a rehabilitation program
Hearing or visual lost that can influence on study tests results
Refuse to participate in the study -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

60 years old and older

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olga N Tkacheva, Dr.	- Pirogov Russian National Research Medical University, the Russian Research and Clinical Center for Gerontology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Russian Research and Clinical Center for Gerontology		Moscow		129226	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms