FrailtyODYSSEYNCT07793708
Older Adults' Recovery Dynamics After Cardiac Surgery
An observational study of Frailty and Resilience, run by University of Chile at 1 site in Chile.
Trial summary
Population aging has increased the number of older adults exposed to interventions with high physiological demand, which are associated with frequent adverse outcomes such as delirium, organ dysfunction, and delayed functional recovery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Resilience, Cardiac Surgery Recovery
- How many people
- 75 participants
- Where
- 1 siteChile
- Study dates
- Oct 2026to Oct 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population will consist of adults aged 65 years or older undergoing elective cardiac surgery, recruited between 2025 and 2026 at Clínica Bicentenario, a high-complexity surgical center located in Santiago, Chile.
Who may be able to join
- Older adults (≥ 65 años) undergoing elective cardiac surgery via median sternotomy, including coronary artery bypass grafting (CABG) and/or valvular surgery.
- Independence in basic daily activities, defined as a Barthel Index score ≥80.
Who cannot join
- Emergency surgery for any indication
- Terminal illness, defined as a life expectancy of less than 12 months
- History of cognitive impairment, defined as a documented diagnosis of dementia and/or current treatment with memantine or donepezil
- Advanced hepatic or renal failure, defined as Child-Pugh class C liver disease or chronic dialysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Clinica Bicentenario Red Salud
Santiago
Felipe Salech, MD PhD, +56998739448, fhsalech@gmail.com
About this study
Official title: Clinical, Functional, and Biological Characterization of Resilience in Older Adults Undergoing Cardiac Surgery: ODYSSEY Study - Pilot Phase
Population aging has increased the number of older adults exposed to interventions with high physiological demand, which are associated with frequent adverse outcomes such as delirium, organ dysfunction, and delayed functional recovery. Current clinical tools, such as frailty assessments, help identify higher-risk populations but do not adequately explain the marked individual variability in recovery or accurately predict who will develop complications. This variability may be partly explained by individual resilience, defined as the ability to recover toward, return to, or even surpass a prior functional state after an acute stressor. Evidence suggests that biological mechanisms related to aging influence resilience; however, biomarkers and integrated clinical models capable of characterizing and potentially modulating resilience in humans remain limited. Therefore, a standardized clinical platform is needed to characterize physiological resilience and its determinants, generating actionable knowledge to improve risk stratification, guide interventions, and optimize recovery in older adults.
To this end, a single-center prospective cohort study will be conducted at Clinica Bicentenario Santiago, including individuals aged ≥65 years who are independent or have mild dependency and are undergoing elective cardiac surgery requiring sternotomy for valvular and/or coronary artery disease, recruited between 2026 and 2027. Participants will undergo a baseline assessment 2-3 weeks before surgery; an early postoperative assessment focused on the systematic recording of clinical outcomes, including delirium and organ dysfunction; and longitudinal follow-up to characterize recovery after discharge. Follow-up assessments will include frailty, intrinsic capacity (the composite of an individual's physical and mental capacities across the cognitive, locomotor, psychological, vitality, and sensory domains), functional status, health-related quality of life, and perceived fatigability, according to the prespecified assessment schedule.
In addition, blood samples will be collected at three time points (baseline, 24 hours postoperatively, and one month after surgery) to measure plasma levels of growth differentiation factor 15 (GDF-15), a biomarker associated with aging-related biological stress and systemic responses to tissue injury. It is projected that at least 75 participants will be recruited over a 12-month period, allowing characterization of baseline clinical and functional profiles, the frequency of postoperative complications and organ dysfunction, trajectories of recovery, and associations between baseline characteristics, biological markers, and subsequent recovery outcomes.
- Conditions
- Frailty, Resilience, Cardiac Surgery Recovery
- Keywords
- Frailty, Resilience, Cardiac surgery, Elderly
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
Frailty measured by the Physical Frailty Phenotype (Fried Frailty Phenotype). The total score ranges from 0 to 5, with higher scores indicating greater frailty. Participants are classified as robust (score 0), prefrail (score 1-2), or frail (score 3-5).
Measured: 1 month after discharge
Functional status assessed by the Barthel Index
Functional status in basic activities of daily living will be assessed using the Barthel Index. The total score ranges from 0 to 100 points, with higher scores indicating greater independence in basic activities of daily living and therefore better functional status.
Measured: 1, 6, and 12 months after discharge
Functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living Index
Functional status in instrumental activities of daily living will be assessed using the Lawton-Brody Instrumental Activities of Daily Living Index. The scale evaluates independence in instrumental activities of daily living, with higher scores indicating greater independence and therefore better functional status.
Measured: 1, 6, and 12 months after hospital discharge
Cognitive capacity assessed by the Montreal Cognitive Assessment
Cognitive capacity will be assessed using the Montreal Cognitive Assessment (MoCA), a cognitive screening instrument evaluating multiple cognitive domains. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance.
Measured: 1 month after hospital discharge
Cognitive capacity assessed by the AD8 Dementia Screening Interview
Cognitive capacity will also be assessed using the AD8 Dementia Screening Interview (AD8), an 8-item screening instrument for cognitive change. The total score ranges from 0 to 8 points, with higher scores indicating greater cognitive impairment and therefore a worse outcome.
Measured: 1 month after hospital discharge
Locomotor capacity assessed by the Short Physical Performance Battery
Locomotor capacity will be assessed using the Short Physical Performance Battery (SPPB), which evaluates standing balance, gait speed, and repeated chair stands. The total score ranges from 0 to 12 points, with higher scores indicating better physical performance.
Measured: 1 month after hospital discharge
Psychological capacity assessed by the Patient Health Questionnaire-9
Psychological capacity will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item instrument assessing depressive symptoms. The total score ranges from 0 to 27 points, with higher scores indicating greater severity of depressive symptoms and therefore a worse outcome.
Measured: 1 month after hospital discharge
Vitality assessed by the Mini Nutritional Assessment-Short Form
Vitality will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF), a nutritional screening instrument for older adults. The total score ranges from 0 to 14 points, with higher scores indicating better nutritional status.
Measured: 1 month after hospital discharge
Visual capacity assessed by the Integrated Care for Older People vision screening tool
Visual capacity will be assessed using the World Health Organization Integrated Care for Older People (ICOPE) vision screening tool. Participants will be classified according to the ICOPE screening assessment as having no evidence of visual impairment or evidence of visual impairment.
Measured: 1 month after hospital discharge
Hearing capacity assessed by the Integrated Care for Older People hearing screening tool
Hearing capacity will be assessed using the World Health Organization Integrated Care for Older People (ICOPE) hearing screening tool. Participants will be classified according to the ICOPE screening assessment as having no evidence of hearing impairment or evidence of hearing impairment.
Measured: 1 month after hospital discharge
Perceived fatigability assessed by the Pittsburgh Fatigability Scale
Perceived fatigability will be assessed using the Pittsburgh Fatigability Scale (PFS), which evaluates anticipated physical and mental fatigue associated with 10 standardized activities. Each activity is rated from 0 to 5 points, with 0 indicating no fatigue and 5 indicating extreme fatigue. Physical fatigability and mental fatigability are scored separately, each ranging from 0 to 50 points. Higher scores indicate greater perceived fatigability and therefore a worse outcome.
Measured: 1 month after hospital discharge
Health-related quality of life assessed by the EuroQol 5-Dimension 3-Level questionnaire
Health-related quality of life will be assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire. The descriptive system evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three response levels: no problems, some or moderate problems, and extreme problems. In addition, participants will rate their overall health using the EuroQol Visual Analogue Scale (EQ VAS), which ranges from 0 to 100, with higher scores indicating better perceived health status.
Measured: 1 month after hospital discharge
Organ dysfunction severity assessed by the Sequential Organ Failure Assessment score
Organ dysfunction severity will be assessed using the Sequential Organ Failure Assessment (SOFA) score, which evaluates respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal function. The total score ranges from 0 to 24 points, with higher scores indicating greater organ dysfunction and therefore a worse outcome.
Measured: During the first 4 postoperative days
Postoperative Delirium
Presence of postoperative delirium assessed during the immediate postoperative period using standardized clinical criteria.
Measured: During the first 4 postoperative days
Survival
All-cause mortality.
Measured: Up to 12 months after hospital discharge.
Secondary outcomes (1)
Growth Differentiation Factor 15 (GDF-15)
Plasma levels of Growth Differentiation Factor 15 (GDF-15) measured as a biomarker of biological stress and resilience.
Measured: 24 hours after cardiac surgery and 1 month after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Salech Morales, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793708
- Sponsor's protocol ID
- P-42.2025
- Acronym
- ODYSSEY
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Functional, and Biological Characterization of Resilience in Older Adults Undergoing Cardiac Surgery: ODYSSEY Study - Pilot Phase
- ClinicalTrials.gov ID
- NCT07793708
- Acronym / sponsor ID
- ODYSSEY / P-42.2025
- Conditions
- Frailty, Resilience, Cardiac Surgery Recovery
- Keywords
- Frailty, Resilience, Cardiac surgery, Elderly
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 28 Aug 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.
Population aging has increased the number of older adults exposed to interventions with high physiological demand, which are associated with frequent adverse outcomes such as delirium, organ dysfunction, and delayed functional recovery. Current clinical tools, such as frailty assessments, help identify higher-risk populations but do not adequately explain the marked individual variability in recovery or accurately predict who will develop complications. This variability may be partly explained by individual resilience, defined as the ability to recover toward, return to, or even surpass a prior functional state after an acute stressor. Evidence suggests that biological mechanisms related to aging influence resilience; however, biomarkers and integrated clinical models capable of characterizing and potentially modulating resilience in humans remain limited. Therefore, a standardized clinical platform is needed to characterize physiological resilience and its determinants, generating actionable knowledge to improve risk stratification, guide interventions, and optimize recovery in older adults.
To this end, a single-center prospective cohort study will be conducted at Clinica Bicentenario Santiago, including individuals aged ≥65 years who are independent or have mild dependency and are undergoing elective cardiac surgery requiring sternotomy for valvular and/or coronary artery disease, recruited between 2026 and 2027. Participants will undergo a baseline assessment 2-3 weeks before surgery; an early postoperative assessment focused on the systematic recording of clinical outcomes, including delirium and organ dysfunction; and longitudinal follow-up to characterize recovery after discharge. Follow-up assessments will include frailty, intrinsic capacity (the composite of an individual's physical and mental capacities across the cognitive, locomotor, psychological, vitality, and sensory domains), functional status, health-related quality of life, and perceived fatigability, according to the prespecified assessment schedule.
In addition, blood samples will be collected at three time points (baseline, 24 hours postoperatively, and one month after surgery) to measure plasma levels of growth differentiation factor 15 (GDF-15), a biomarker associated with aging-related biological stress and systemic responses to tissue injury. It is projected that at least 75 participants will be recruited over a 12-month period, allowing characterization of baseline clinical and functional profiles, the frequency of postoperative complications and organ dysfunction, trajectories of recovery, and associations between baseline characteristics, biological markers, and subsequent recovery outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population will consist of adults aged 65 years or older undergoing elective cardiac surgery, recruited between 2025 and 2026 at Clínica Bicentenario, a high-complexity surgical center located in Santiago, Chile.
Key inclusion criteria (2 listed)
- Older adults (≥ 65 años) undergoing elective cardiac surgery via median sternotomy, including coronary artery bypass grafting (CABG) and/or valvular surgery.
- Independence in basic daily activities, defined as a Barthel Index score ≥80.
Key exclusion criteria (4 listed)
- Emergency surgery for any indication
- Terminal illness, defined as a life expectancy of less than 12 months
- History of cognitive impairment, defined as a documented diagnosis of dementia and/or current treatment with memantine or donepezil
- Advanced hepatic or renal failure, defined as Child-Pugh class C liver disease or chronic dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frailty
Time frame: 1 month after discharge
Frailty measured by the Physical Frailty Phenotype (Fried Frailty Phenotype). The total score ranges from 0 to 5, with higher scores indicating greater frailty. Participants are classified as robust (score 0), prefrail (score 1-2), or frail (score 3-5).
Functional status assessed by the Barthel Index
Time frame: 1, 6, and 12 months after discharge
Functional status in basic activities of daily living will be assessed using the Barthel Index. The total score ranges from 0 to 100 points, with higher scores indicating greater independence in basic activities of daily living and therefore better functional status.
Functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living Index
Time frame: 1, 6, and 12 months after hospital discharge
Functional status in instrumental activities of daily living will be assessed using the Lawton-Brody Instrumental Activities of Daily Living Index. The scale evaluates independence in instrumental activities of daily living, with higher scores indicating greater independence and therefore better functional status.
Cognitive capacity assessed by the Montreal Cognitive Assessment
Time frame: 1 month after hospital discharge
Cognitive capacity will be assessed using the Montreal Cognitive Assessment (MoCA), a cognitive screening instrument evaluating multiple cognitive domains. The total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance.
Cognitive capacity assessed by the AD8 Dementia Screening Interview
Time frame: 1 month after hospital discharge
Cognitive capacity will also be assessed using the AD8 Dementia Screening Interview (AD8), an 8-item screening instrument for cognitive change. The total score ranges from 0 to 8 points, with higher scores indicating greater cognitive impairment and therefore a worse outcome.
Locomotor capacity assessed by the Short Physical Performance Battery
Time frame: 1 month after hospital discharge
Locomotor capacity will be assessed using the Short Physical Performance Battery (SPPB), which evaluates standing balance, gait speed, and repeated chair stands. The total score ranges from 0 to 12 points, with higher scores indicating better physical performance.
Psychological capacity assessed by the Patient Health Questionnaire-9
Time frame: 1 month after hospital discharge
Psychological capacity will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item instrument assessing depressive symptoms. The total score ranges from 0 to 27 points, with higher scores indicating greater severity of depressive symptoms and therefore a worse outcome.
Vitality assessed by the Mini Nutritional Assessment-Short Form
Time frame: 1 month after hospital discharge
Vitality will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF), a nutritional screening instrument for older adults. The total score ranges from 0 to 14 points, with higher scores indicating better nutritional status.
Visual capacity assessed by the Integrated Care for Older People vision screening tool
Time frame: 1 month after hospital discharge
Visual capacity will be assessed using the World Health Organization Integrated Care for Older People (ICOPE) vision screening tool. Participants will be classified according to the ICOPE screening assessment as having no evidence of visual impairment or evidence of visual impairment.
Hearing capacity assessed by the Integrated Care for Older People hearing screening tool
Time frame: 1 month after hospital discharge
Hearing capacity will be assessed using the World Health Organization Integrated Care for Older People (ICOPE) hearing screening tool. Participants will be classified according to the ICOPE screening assessment as having no evidence of hearing impairment or evidence of hearing impairment.
Perceived fatigability assessed by the Pittsburgh Fatigability Scale
Time frame: 1 month after hospital discharge
Perceived fatigability will be assessed using the Pittsburgh Fatigability Scale (PFS), which evaluates anticipated physical and mental fatigue associated with 10 standardized activities. Each activity is rated from 0 to 5 points, with 0 indicating no fatigue and 5 indicating extreme fatigue. Physical fatigability and mental fatigability are scored separately, each ranging from 0 to 50 points. Higher scores indicate greater perceived fatigability and therefore a worse outcome.
Health-related quality of life assessed by the EuroQol 5-Dimension 3-Level questionnaire
Time frame: 1 month after hospital discharge
Health-related quality of life will be assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire. The descriptive system evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three response levels: no problems, some or moderate problems, and extreme problems. In addition, participants will rate their overall health using the EuroQol Visual Analogue Scale (EQ VAS), which ranges from 0 to 100, with higher scores indicating better perceived health status.
Organ dysfunction severity assessed by the Sequential Organ Failure Assessment score
Time frame: During the first 4 postoperative days
Organ dysfunction severity will be assessed using the Sequential Organ Failure Assessment (SOFA) score, which evaluates respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal function. The total score ranges from 0 to 24 points, with higher scores indicating greater organ dysfunction and therefore a worse outcome.
Postoperative Delirium
Time frame: During the first 4 postoperative days
Presence of postoperative delirium assessed during the immediate postoperative period using standardized clinical criteria.
Survival
Time frame: Up to 12 months after hospital discharge.
All-cause mortality.
1 secondary outcome
Growth Differentiation Factor 15 (GDF-15)
Time frame: 24 hours after cardiac surgery and 1 month after hospital discharge
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 28 Aug 2026.
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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.
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 Frailty and Resilience, run by University of Chile at 1 site in Chile.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 Aug 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 Chile. 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?
Contact Felipe H Salech, MD PhD (+56998739448, fhsalech@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: 1 month after discharge). The study lists 15 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 28 Aug 2026.