Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorUniversity of Vigo
About this trial
This prospective observational study will describe changes in physical function and fall risk among adults aged 70 years or older who participate in the routine Frailty and Falls Prevention Program at the Centro Integral de Saúde de Lalín. Clinical assessments obtained before the program (T0) and at its completion (T1, approximately 8-12 weeks later) will be analyzed. The study does not assign treatment or change routine care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adults aged 70 years or older linked to the Centro Integral de Saúde de Lalín who enter its routine Frailty and Falls Prevention Program through usual care and can provide informed consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
56 Participants
are grouped into 1 trial groupGroup A: Participants in the Lalín Frailty and Falls Prevention Program: adults aged 70 years or older with B
Trial outcomes
Primary outcomes
1
Change in Short Physical Performance Battery (SPPB) Total Score
Change in SPPB total score, a composite measure of lower-extremity function comprising standing balance, gait speed and chair rise. Score range: 0-12 points. Higher scores indicate better physical performance. Unit: points.
Time frame
Baseline (T0) and end of the care program (T1, 8-12 weeks).2
Change in Fall Risk Indicators
Change in the three protocol-defined yes/no indicators: a fall in the preceding year requiring healthcare, two or more falls in the preceding year, and clinically relevant gait impairment. Each indicator is recorded as No or Yes; no composite score or fixed numerical range is specified. A Yes response indicates the corresponding risk feature.
Time frame
Baseline (T0) and end of the care program (T1, 8-12 weeks); each assessment uses the protocol-defined recall or clinical assessment.Secondary outcomes
1
Change in Timed Up and Go Test Time
Time to stand, walk, turn, return and sit, recorded in seconds. Lower values indicate better mobility. Minimum: 0 seconds; no fixed maximum is specified in the protocol. The test is described as an alternative screening test in Section 4.4 and as a T0/T1 measure in the data collection form.
Time frame
Baseline (T0) and end of the care program (T1, 8-12 weeks).2
Change in FRAIL Scale Total Score
Change in FRAIL questionnaire total score. Score range: 0-5 points; higher scores indicate greater frailty. FRAIL Scale total score. The score ranges from 0 to 5 points, with higher scores indicating greater frailty. Unit: points.
Time frame
Baseline (T0) and end of the care program (T1, 8-12 weeks).3
Change in Number of Chronic Prescription Medications
Number of medicines prescribed chronically at each assessment. Unit: medication count; minimum 0, with no fixed maximum. Higher values indicate more chronic prescribed medicines, not necessarily a better or worse clinical outcome.
Time frame
Baseline (T0) and end of the care program (T1, 8-12 weeks).4
Change in 4 Meter Gait Speed
Usual gait speed over 4 meters, expressed in meters per second. Minimum 0 m/s; no fixed maximum is specified. Higher values indicate faster walking.
Time frame
Baseline (T0) and end of the care program (T1, 8-12 weeks).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Vigo
Lead sponsor
Servicio Gallego de Salud
Collaborator
Source ClinicalTrials.gov