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This is a pilot trial to test the feasibility of a multimodal lifestyle intervention (physical activity, mindfulness, sleep routines, calorie-restricted Mediterranean diet, supplements: vitamin D, omega-3, Multivitamin-mineral Centrum50+®, plant-based-supplement Fruitflow®) in preparation of a larger clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multimodal intervention | Active Comparator |
| |
| control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multimodal lifestyle intervention: | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: eligibility rate | Proportion of screened individuals who meet Inclusion/Exclusion Criteria (eligibility rate), and the most common reasons for ineligibility by criterion | baseline |
| Feasibility: recruitment rate | Recruitment rate (participants enrolled per week) and total time required to enroll n=10 | baseline |
| Feasibility: enrollment rate | Proportion of eligible individuals who provide consent and are enrolled | baseline |
| Feasibility: Retention | Proportion of enrolled participants who complete the Day 14 visit | 14 days |
| Feasibility: drop-out rate | Proportion of enrolled participants who withdraw prior to Day 14, with reasons for withdrawal summarized | 14 days |
| Feasibility: assessment completion rate | Completion rate for each major assessment at Baseline and Day 14 (6-minute Walk Test (6MWT), knee extensor muscle strength measurements, Cambridge Neuropsychological Test Automated Battery (CANTAB®)), including the proportion with valid/usable results | 14 days |
| Feasibility: data completeness (proportion with complete primary endpoint data at Day 14) | Data completeness for the overall assessment battery at Day 14 (proportion with complete primary endpoint data at Day 14), with documentation of missingness reasons (participant burden, scheduling, technical failure, etc.) |
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| Measure | Description | Time Frame |
|---|---|---|
| muscle function | Change in muscle function based on 6MWT Test and knee extensor muscle strength measurements from Baseline to 14 days in the intervention compared to the control group; | 14 days |
| cognitive function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heike A Bischoff-Ferrari, Prof. Dr. med., DrPH | Universitäre Altersmedizin Felix Platter | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäre Altersmedizin Felix Platter | Basel | Canton of Basel-City | 4055 | Switzerland |
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|
| 14 days |
| Feasibility: acceptability of study | Participant-reported acceptability of study procedures by Day 14 (brief questionnaire or structured feedback) | 14 days |
| Feasibility: willingness to participate in a longer trial | Proportion of participants indicating willingness to participate in a longer (e.g., 1-year) trial using the same or similar procedures | 14 days |
| Safety/tolerability: serious adverese events | Proportion experiencing any adverse event by Day 14 | 14 days |
| Safety/tolerability: related serious adverese events | Proportion considered related to interventions | 14 days |
Change in Cognitive function based on the CANTAB® digital cognitive assessment tool from Baseline to 14 days in the intervention compared to the control group
| 14 days |
| participant-reported outcome: Short Form (SF)-36 Health Survey | Change in participant-reported outcomes in the health-related quality of life (Short Form (SF)-36 Health Survey (SF-36)) questionnaire from baseline to 14 days in the intervention compared to the control group. | 14 days |
| participant-reported outcome: Perceived Stress Scale-10 | Change in participant-reported outcomes in stress level (Perceived Stress Scale-10) from baseline to 14 days in the intervention compared to the control group. | 14 days |
| participant-reported outcome: Generalized Anxiety Disorder Screener (GAD-7) | Change in participant-reported outcome in self-reported anxiety (Generalized Anxiety Disorder Screener, GAD-7) from baseline to 14 days in the intervention compared to the control group. | 14 days |
| participant-reported outcome: infections | Change in participant-reported outcomes based on number of infections and sick days from baseline to 14 days in the intervention compared to the control group. | 14 days |
| blood pressure | Change in systolic and diastolic blood pressure from baseline to 14 days in the intervention compared to the control group. | 14 days |
| Arrhythmia | Incidence of arrhythmia in the electrocardiogram (ECG) from baseline to 14 days in the intervention compared to the control group. | 14 days |
| healthcare utilization costs | Healthcare utilization costs, assessed prospectively at baseline and 14 days with a simple questionnaire developed for DO-HEALTH. | 14 days |