FrailtyNCT07623694
Clinical and Functional Effectiveness Assessment of Personalized Management Programs for Patients With Frailty
A study testing Geriatric rehabilitation program based on CGA and CPET in people with Frailty and Frailty/Sarcopenia, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty, Frailty/Sarcopenia
- What is being tested?
- Geriatric rehabilitation program based on CGA and CPET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteRussia
- Study dates
- 14 Apr 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 1. Men and women aged 60 and older who wanted to participate in the study and signed a consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Russian Research and Clinical Center for Gerontology
Moscow, 129226
About this study
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.
Read the detailed description
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
- Conditions
- Frailty, Frailty/Sarcopenia
- Being tested
- Geriatric rehabilitation program based on CGA and CPET
- Keywords
- geriatric rehabilitation, elderly, frailty, Complex geriatric assessment, Cardiopulmonary exercise testing
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric rehabilitation program based on CGA and CPETOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Frailty | Experimental | Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET Receives: Other: Geriatric rehabilitation program based on CGA and CPET |
| Prefrailty | Experimental | Pre-Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET Receives: Other: Geriatric rehabilitation program based on CGA and CPET |
| Robust | Experimental | Non-frail Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET Receives: Other: Geriatric rehabilitation program based on CGA and CPET |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional status dynamics
Instrumental and Basic Activity Daily Life scale score
Measured: 6 months
Change in aerobic exercise capacity
eak oxygen uptake (VO₂ peak) measured during cardiopulmonary exercise testing (CPET)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start14 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- his is a prospective, non-randomized, parallel-group study. Participants are assigned to one of three final groups (Robust, Prefrailty, Frailty) based on a sequential algorithm using the questionnaire "Vozrast ne pomekha" (0-7 points) and the Short Physical Performance Battery (SPPB; 0-12 points): Step 1 - Questionnaire "Vozrast ne pomekha" score: \< 3 points → further stratified by SPPB: SPPB 10-12 → Robust SPPB 8-9 → Prefrailty SPPB ≤7 → Frailty 3-4 points → further stratified by SPPB: SPPB ≥8 → Prefrailty SPPB ≤7 → Frailty ≥ 5 points → Frailty (regardless of SPPB score)
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
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
- NCT07623694
- Sponsor's protocol ID
- CPET/GR
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Functional Effectiveness Assessment of Personalized Management Programs for Patients With Frailty
- ClinicalTrials.gov ID
- NCT07623694
- Acronym / sponsor ID
- CPET/GR
- Conditions
- Frailty, Frailty/Sarcopenia
- Keywords
- geriatric rehabilitation, elderly, frailty, Complex geriatric assessment, Cardiopulmonary exercise testing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Jun 2026 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- his is a prospective, non-randomized, parallel-group study. Participants are assigned to one of three final groups (Robust, Prefrailty, Frailty) based on a sequential algorithm using the questionnaire "Vozrast ne pomekha" (0-7 points) and the Short Physical Performance Battery (SPPB; 0-12 points): Step 1 - Questionnaire "Vozrast ne pomekha" score: < 3 points → further stratified by SPPB: SPPB 10-12 → Robust SPPB 8-9 → Prefrailty SPPB ≤7 → Frailty 3-4 points → further stratified by SPPB: SPPB ≥8 → Prefrailty SPPB ≤7 → Frailty ≥ 5 points → Frailty (regardless of SPPB score)
| Arm | Type | Receives |
|---|---|---|
| Frailty | Experimental | Other: Geriatric rehabilitation program based on CGA and CPETFrail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET |
| Prefrailty | Experimental | Other: Geriatric rehabilitation program based on CGA and CPETPre-Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET |
| Robust | Experimental | Other: Geriatric rehabilitation program based on CGA and CPETNon-frail Frail subjects of 60 years and older will get geriatric rehabilitation program based on CGA and CPET |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Men and women aged 60 and older who wanted to participate in the study and signed a consent form.
Key exclusion criteria (7 listed)
- 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.
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 CGA and CPETGeriatric 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. | Other | Frailty, Prefrailty, Robust |
Primary outcome
functional status dynamics
Time frame: 6 months
Instrumental and Basic Activity Daily Life scale score
Change in aerobic exercise capacity
Time frame: 6 months
eak oxygen uptake (VO₂ peak) measured during cardiopulmonary exercise testing (CPET)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- 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?
A study testing Geriatric rehabilitation program based on CGA and CPET in people with Frailty and Frailty/Sarcopenia, 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 1 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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: 6 months). The study lists 2 primary outcomes in all. 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 3 Jun 2026.