Older Adults' Recovery Dynamics After Cardiac Surgery

NCT07793708 | Not Yet Recruiting

• 1 other identifier: P-42.2025
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (15)

• 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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  During the first 4 postoperative days

• Postoperative Delirium

  Presence of postoperative delirium assessed during the immediate postoperative period using standardized clinical criteria.

  During the first 4 postoperative days

• Survival

  All-cause mortality.

  Up to 12 months after hospital discharge.

Secondary Outcomes (1)

• Growth Differentiation Factor 15 (GDF-15)

  24 hours after cardiac surgery and 1 month after hospital discharge

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Clinica Bicentenario Red Salud

Santiago, Chile

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Felipe H Salech, MD PhD

CONTACT

+56998739448; fhsalech@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

CL (1)