Effects of VIVIFRAIL Program on Functional Capacity and Geriatric Syndromes in the Elderly.
ConditionFragility
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorElena Pérez Expósito, MD
About this trial
The aim of this quasi-experimental, pretest-posttest study is to evaluate the effectiveness of the Vivifrail multicomponent physical exercise program in improving the functional capacity of pre-frail and frail older adults (aged 70 and older) attending the Virgen del Mar Health Center in Almería.
The main questions it aims to answer are:
* Does functional capacity, as measured by the Short Physical Performance Battery (SPPB), significantly improve after participating in the Vivifrail program? * What is the effect of the Vivifrail program on various geriatric syndromes and associated health conditions (e.g., fall risk, sarcopenia, chronic pain, mild cognitive impairment, depression), and what patient profile is most likely to benefit from the intervention? * As a single-arm interventional study, there is no parallel comparison group. Researchers will compare each participant's outcomes against their own baseline at three time points (baseline, week 6, and week 12) to assess for significant improvements following the intervention.
Participants will:
* Complete a 12-week home-based, multicomponent physical exercise program (five sessions per week including strength, balance, flexibility, and aerobic endurance training), tailored to their baseline functional level. * Attend three in-person visits at the health center (baseline, a 6-week follow-up, and a final visit at 12 weeks) for the research staff to assess their clinical, functional, and sociodemographic variables. * Complete an Activity Diary to record their home-based sessions and perceived rate of exertion in order to monitor adherence. * Receive biweekly follow-up phone calls from the research team to reinforce motivation, track adherence, and monitor for any potential adverse events (e.g., falls, pain).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Behavioral: Vivifrail multicomponent physical exercise program
Other interventionThe Vivifrail multicomponent physical exercise program is a structured, 12-week home-based regimen. The standardized protocol requires 5 sessions per week: 3 non-consecutive days of 45-60 minute multicomponent training (focusing on upper and lower body strength using household items like water bottles or elastic bands, static/dynamic balance, and flexibility) and 2 days of 20-40 minute aerobic endurance training (brisk walking). Exercise intensity is prescribed at a moderate rate of perceived exertion (Borg scale 4-6). A systematic progression in exercise load and duration is implemented starting at week 7, strictly adhering to the guidelines of the participant's assigned passport.
Treatment groups
86 Participants
are divided into 1 treatment groupGroup A: Vivifrail Exercise ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Functional Capacity measured by the Short Physical Performance Battery (SPPB)
The SPPB assesses physical performance and functional capacity through three sequential subtests: static balance (side-by-side, semi-tandem, and tandem stands for 10 seconds each), gait speed (time to walk 4 meters at a normal pace), and lower body strength (time to rise from a chair and sit down 5 consecutive times). The total SPPB score is calculated by summing the scores of the three subtests, yielding a final continuous score that ranges from 0 to 12. Clinical thresholds: A total score of \< 10 points indicates a high probability of frailty and an elevated risk of disability and falls. According to the Vivifrail classification, the scores categorize the patient's functional level as Disability (0-3 points), Frailty (4-6 points), Pre-frailty (7-9 points), or Robustness (10-12 points). A change of 1 point is considered clinically meaningful.
Time frame
Baseline, Week 6, and Week 12Secondary outcomes
1
Body Mass Index (BMI)
Body Mass Index is calculated as weight in kilograms divided by the square of height in meters (kg/m2). It is evaluated as a continuous quantitative measure to assess changes in the participant's body composition and nutritional status throughout the intervention.
Time frame
Baseline, Week 6, and Week 122
Chronic Pain Intensity measured by the Visual Analogue Scale (VAS)
Chronic pain intensity is assessed using a 10-centimeter Visual Analogue Scale (VAS). Participants mark a point on the line that best represents their current pain level. The score is measured in centimeters from the left end (0) to the participant's mark, yielding a score from 0 to 10. Direction of the scale: A score of 0 represents "no pain" (best outcome), while a score of 10 represents the "worst imaginable pain" (worst outcome). Clinical interpretation of the scores is categorized as follows: 0 = No pain; 1 to 3 = Mild pain; 4 to 6 = Moderate pain; 7 to 10 = Severe pain.
Time frame
Baseline, Week 6, and Week 123
Appetite Perception measured by the Visual Analogue Scale (VAS)
Appetite perception is assessed using a 10-centimeter Visual Analogue Scale (VAS). Participants mark a point on a continuous line that best reflects their current level of appetite. The score is measured in centimeters from the left anchor (0) to the participant's mark, resulting in a continuous score from 0 to 10. Direction of the scale: A score of 0 represents "no appetite" (worst outcome, indicating potential risk of malnutrition or anorexia of aging), while a score of 10 represents "maximum appetite" (best outcome). Clinical interpretation categorizes the scores as follows: 0 = No appetite; 1 to 3 = Mild appetite; 4 to 6 = Moderate appetite; 7 to 10 = Intense/strong appetite.
Time frame
Baseline, Week 6, and Week 124
Proportion of Participants with High Fall Risk according to Vivifrail Criteria
Fall risk is evaluated as a dichotomous qualitative variable (High Risk vs. No High Risk) following the Vivifrail program protocol. A participant is classified as having a "High Fall Risk" if they meet one or more of the following five clinical criteria: 1) Two or more falls in the previous 12 months; 2) One fall in the previous 12 months requiring medical attention; 3) Timed Up and Go (TUG) test execution time \> 20 seconds; 4) 6-meter gait speed \< 0.8 m/s; or 5) A clinical diagnosis of dementia.
Time frame
Baseline, Week 6, and Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Elena Pérez Expósito, MD
Lead sponsor
Andaluz Health Service
Sponsor institution
Source ClinicalTrials.gov
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