Frail Elderly SyndromePOSTSCRIPTUMNCT05740436
Protocol of Geriatric Rehabilitation in Patients of 60 and Older Who Live in Moscow Boarding Houses or Nursing Homes
An observational study of Frail Elderly Syndrome, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Geriatric rehabilitation program based on CGA
- How many people
- 420 participants
- Where
- 1 siteRussia
- Study dates
- 21 Aug 2021to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: men and women aged 60 years and older eligible for geriatric rehabilitation, who were addmited to one of the study sites
Who may be able to join
- 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)
Who cannot join
- One or more contraindications to geriatric rehabilitation:
- Severe sensory and cognitive impairment hampering rehabilitation
- End stage diseases requiring palliative care
- 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 -
Trial locations and contacts
1 site in 1 country.
Russia1 site
Russian Research and Clinical Center for Gerontology
Moscow, 129226
About this study
Official title: 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.
Read the 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
- Being tested
- Geriatric rehabilitation program based on CGA
- Keywords
- geriatric rehabilitation, elderly, frailty, Complex geriatric assessment
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric rehabilitation program based on CGAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Frail elderly subjects | Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA Receives: 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 Receives: 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 Receives: Other: Geriatric rehabilitation program based on CGA |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional status dynamics
Instrumental Activity Daily Life scale score
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start21 Aug 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga N Tkacheva, Dr., Principal investigator, - Pirogov Russian National Research Medical University, the Russian Research and Clinical Center for Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740436
- Sponsor's protocol ID
- 2021/GR
- Acronym
- POSTSCRIPTUM
- Status last verified
- May 2025
- First submitted
- 13 Feb 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05740436
- Acronym / sponsor ID
- POSTSCRIPTUM / 2021/GR
- Conditions
- Frail Elderly Syndrome
- Keywords
- geriatric rehabilitation, elderly, frailty, Complex geriatric assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Frail elderly subjects | – | Other: Geriatric rehabilitation program based on CGAFrail subjects of 60 years and older will get geriatric rehabilitation program based on CGA |
| Pre-Frail elderly subjects | – | Other: Geriatric rehabilitation program based on CGAPre-Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA |
| Non-frail elderly Frail subjects | – | Other: Geriatric rehabilitation program based on CGANon-frail Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men and women aged 60 years and older eligible for geriatric rehabilitation, who were addmited to one of the study sites
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (8 listed)
- One or more contraindications to geriatric rehabilitation:
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric rehabilitation program based on CGAGeriatric 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. | Other | Frail elderly subjects, Non-frail elderly Frail subjects, Pre-Frail elderly subjects |
Primary outcome
functional status dynamics
Time frame: 13 months
Instrumental Activity Daily Life scale score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga N Tkacheva, Dr. principal investigator
- Pirogov Russian National Research Medical University, the Russian Research and Clinical Center for Gerontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional status dynamics (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.