In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults

Change From Baseline in the Prespecified 40-Item Frailty Index Score at 6 Months

A prespecified 40-item deficit-accumulation Frailty Index (40-FI) will be calculated as the sum of observed deficit scores divided by the number of evaluable deficits. The 40-FI ranges from 0 to 1, with higher values indicating greater frailty. A score will be calculated when at least 32 of the 40 deficits (80%) are evaluable. Change will be calculated as the 6-month score minus the baseline score; negative values indicate improvement. The fixed item list, item-level coding rules, permitted intermediate values, denominator, and missing-data rules are defined in the version-controlled 40-FI Specification included as an annex to Protocol and SAP and finalized before enrolment of the first participant.

Change From Baseline in the Prespecified 40-Item Frailty Index Score at 12 Months

A prespecified 40-item deficit-accumulation Frailty Index (40-FI) will be calculated as the sum of observed deficit scores divided by the number of evaluable deficits. The 40-FI ranges from 0 to 1, with higher values indicating greater frailty. A score will be calculated when at least 32 of the 40 deficits (80%) are evaluable. Change will be calculated as the 12-month score minus the baseline score; negative values indicate improvement. The fixed item list, item-level coding rules, permitted intermediate values, denominator, and missing-data rules are defined in the version-controlled 40-FI Specification included as an annex to Protocol and SAP and finalized before enrolment of the first participant.

Change From Baseline in the Fried Frailty Phenotype Score at 6 and 12 Months

The Fried frailty phenotype will be scored at baseline, 6 months, and 12 months as the number of criteria present (0-5): unintentional weight loss, exhaustion, weakness, slowness, and low physical activity; higher scores indicate greater frailty. At baseline, weight loss is self-reported unintentional loss \>4.5 kg in the previous 12 months; at 6 and 12 months, it is measured loss ≥5% from baseline reported as unintentional. Exhaustion is present when either original CES-D item is reported ≥3 days in the previous week. Weakness uses the highest of three dominant-hand grip-strength trials and original sex- and BMI-specific cutoffs. Slowness uses usual-paced 4.57-m walk time and original sex- and height-specific cutoffs. Low activity is VREM \<1,250 MET-min/14 days. Each criterion scores 0 or 1. Separate changes are 6-month minus baseline and 12-month minus baseline (range, -5 to 5); negative values indicate improvement. All five criteria are required.

Change From Baseline in Maximum Dominant-Hand Grip Strength at 6 and 12 Months

Maximum dominant-hand grip strength will be measured in kilograms with a calibrated Jamar hydraulic dynamometer at handle position II. Higher values indicate greater strength. Participants will be seated with shoulder adducted and neutrally rotated, elbow flexed 90°, forearm neutral, wrist at 0-30° extension and 0-15° ulnar deviation, and feet supported. Three maximal contractions of 3-5 seconds will be performed with 60 seconds of rest and standardized encouragement. The highest valid value will be analyzed; if fewer than three trials are valid, the highest available value will be used. At least one valid trial is required. Changes will be calculated separately as 6-month minus baseline and 12-month minus baseline; positive values indicate improvement and negative values worsening. The baseline dominant hand and same device, handle setting, and protocol will be used at all visits. Values and reasons for invalid or missing trials will be recorded.

Change From Baseline in Short Physical Performance Battery Total Score at 6 and 12 Months

The SPPB assesses lower-extremity performance using standing balance (side-by-side, semi-tandem, and tandem stances), usual-paced walking over 4 meters, and five chair rises performed as quickly as possible with arms folded. Each component is scored 0-4 according to standard rules, producing a total score from 0 to 12; higher scores indicate better performance. The faster valid time from two usual-paced 4-meter walks determines the gait score; if only one trial is valid, it is used. Participants unable to complete a component for physical or safety reasons receive 0 points. A usual walking aid may be used; its type will be recorded and kept constant when clinically appropriate. Separate changes are the 6-month total minus baseline and the 12-month total minus baseline (range, -12 to 12); positive values indicate improvement and negative values worsening. The same equipment, instructions, sequence, stopping rules, and scoring will be used at all assessments.

Change From Baseline in the Individual Fried Frailty Phenotype Criteria at 6 and 12 Months

The five binary criteria contributing to the Fried frailty phenotype will be evaluated separately: unintentional weight loss, exhaustion, weakness, slowness, and low physical activity. Definitions and cutoffs will be identical to those specified for the Fried phenotype total-score outcome. For each criterion, transitions between absence and presence and the proportion of participants meeting the criterion will be reported at baseline, 6 months, and 12 months. Improvement is defined as transition from present to absent; worsening is transition from absent to present.

Change From Baseline in Usual-Pace 4-Meter Gait Speed at 6 and 12 Months

Usual-paced gait speed will be obtained from the Short Physical Performance Battery 4-meter walk and reported in meters per second. Two trials will be performed; the faster valid time will be used, or the single valid trial when only one is available. Speed will be calculated as 4 divided by time in seconds. The usual walking aid is permitted and recorded. Changes will be calculated separately as 6-month minus baseline and 12-month minus baseline; positive values indicate faster gait.

Change From Baseline in Five-Repetition Sit-to-Stand Completion Time at 6 and 12 Months

Five-repetition sit-to-stand completion time will be obtained from the chair-rise component of the Short Physical Performance Battery and reported in seconds. Participants will rise five times as quickly as possible from the standardized chair with arms folded. The outcome will be available only for a valid completed test. Changes will be calculated separately as 6-month minus baseline and 12-month minus baseline; negative values indicate faster performance.

Change From Baseline in Self-Reported Physical Activity Assessed With the VREM at 6 and 12 Months

Self-reported habitual physical activity will be assessed with the validated Spanish short version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM). Energy expenditure will be calculated from activity type, frequency, and duration and expressed as MET-minutes per 14 days using the prespecified scoring algorithm. Higher values indicate greater self-reported physical activity. Changes will be calculated separately as 6-month minus baseline and 12-month minus baseline.