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

NCT ID: NCT05740436

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 420 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-21
• Study Completion Date: 2024-08-31

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.

Conditions

Frail Elderly Syndrome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Frail elderly subjects

Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA

Geriatric rehabilitation program based on CGA

Intervention Type: 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.

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

Intervention Type: 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.

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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 -

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pirogov Russian National Research Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga N Tkacheva, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Russian Research and Clinical Center for Gerontology

Moscow, , Russia

Countries

Russia

Other Identifiers

2021/GR

Identifier Type: -

Identifier Source: org_study_id