Table 2.
Schedule for events and measurements of enrolment, interventions, and assessments
| Study Period | |||||||
|---|---|---|---|---|---|---|---|
| Enrolment | Allocation | Post-allocation | Close-out | ||||
| Timepoint | -t1 | 0 | t1 (Baseline) |
t2 (4 weeks) |
t3 (8 weeks) |
t4 (16 weeks) |
tx (32 weeks) |
| ENROLMENT: | |||||||
| Eligibility screen | X | ||||||
| Informed consent | X | ||||||
| Randomization | X | ||||||
| Allocation | X | ||||||
| Blinding | X | ||||||
| INTERVENTIONS: | |||||||
| Bundle arm | X | X | X | ||||
| IMT arm | X | X | X | ||||
| Control arm | X | X | X | ||||
| ASSESSMENTS: | |||||||
| Demographics | X | X | X | X | X | ||
| Medical records | X | X | X | X | |||
| Questionnaire | |||||||
| Smoking | X | X | X | X | |||
| Drinking | X | X | X | X | |||
| FFQ | X | X | X | X | |||
| IPAQ | X | X | X | X | |||
| PSQI | X | X | X | X | |||
| GAD-7 | X | X | X | X | |||
| PHQ-9 | X | X | X | X | |||
| mGSES | X | X | X | X | |||
| Implicit health attitude | X | X | X | X | |||
| SF-36 | X | X | X | X | |||
| Satisfaction and adherence evaluation | X | ||||||
| Physical examination | |||||||
| Height | X | ||||||
| Weight | X | X | X | X | X | ||
| Body circumference a | X | X | X | X | X | ||
| Pulmonary function b | X | X | X | X | X | ||
| Pulse rate | X | X | X | X | X | ||
| Finger pulse oxygen | X | X | X | X | X | ||
| Body composition | X | X | X | X | X | ||
| Blood pressure | X | X | X | X | X | ||
| Grip strength | X | X | X | X | X | ||
| SPPB c | X | X | X | X | X | ||
| PWV | X | X | X | X | X | ||
| 24 h wearable device | X | X | X | ||||
| Electrocardiogram | X | X | X | ||||
| Laboratory test | |||||||
| Blood laboratory tests d | X | X | X | ||||
| Stool laboratory tests e | X | X | X | ||||
FFQ, Food Frequency Questionnaire; IPAQ, short version of the International Physical Activity Questionnaire; PSQI, Pittsburgh Sleep Quality Index; GAD-7, 7-item scale for General Anxiety Disorder; PHQ-9, patient health questionnaire depression module; mGSES, modified General Self-Efficacy Scale; SF-36, 36-item short form survey; SPPB, Short Physical Performance Battery; PWV, pulse wave velocity
aBody circumference included neck, waist, belly, hip, arm and leg circumference
bPulmonary function assessment includes Forced Expiratory Volume in 1 s (FEV1), Forced Vital Capacity (FVC), FEV1% predicted (FEV1%Pre), Maximum Inspiratory Pressure (MIP), and Maximum Expiratory Pressure (MEP)
cSPPB included feet together test, semi-tandem stand test, tandem stand test, 4-meter walk test, and five times sit-to-stand test
dBlood tests include complete blood count (CBC) testing and biochemical analysis. The former encompasses indicators such as total white blood cell count (WBC), red blood cells (RBC), hemoglobin (HGB), platelets (PLT), lymphocytes, monocytes, neutrophils, and eosinophils. The latter includes indicators such as fasting blood glucose (FBG), triglycerides (TG), cholesterol (CHOL), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total protein (TP), albumin, globulin, alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), creatinine (Cr), urea, uric acid (UA), C-reactive protein (CRP), high-sensitivity C-reactive protein (hsCRP), serum iron, alkaline phosphatase (ALP), total bilirubin (TBIL), apolipoprotein A-I (ApoA-I), apolipoprotein B (ApoB), creatine kinase-isoenzymes (CK-MB), hemoglobin A1c, interleukin 6 (IL-6), interleukin 10 (IL-10), insulin (INS), and C-peptide (C-P)
eStool laboratory tests include transcriptomic, metagenomic, and metabolomic analyses
X The item will be implemented or on relevant time point