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Table 2 Overview of outcomes, outcome measures, instruments and assessment time points

From: The SITLESS project: exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: study protocol for a randomised controlled trial

Outcomes Outcome measures Instrument Assessment time pointa
Personal information Age, gender, civil status, living arrangement, educational background, medical conditions, and smoking and alcohol habits. Primary care records Self-report T0
Primary outcomes
 Sedentary behaviour Sitting time and the number of minutes spent in activities requiring ≤ 1.5 Metabolic Equivalent Tasks. Actigraph®
ActivPal®
Axivity®
Sedentary Behavior Questionnaire
T0, T1, T2, T3
 Physical activity Daily counts per minute and intensity of exercise, and daily step counts. Actigraph® T0, T1, T2, T3
 Secondary outcomes
 Physical function General function Aerobic capacity Static balance SPPB
2-minutes’ walk test Unipedal stance
T0, T1, T2, T3
 Muscle function Handgrip strength Takei analogue Hand Grip Dynamometer T0, T1, T2, T3
Mean strength and power with concentric contraction of isoinertial movement performing 3 exercises: (a) 30-s chair stand rise; (b) five repetitions of arm curl with both hands using a 2-kg and 4-kg weight; and (c) four counter-movement jumps. Linear encoder
 Health economics’ related outcomes Use of sport services, and use of health and social services, medications, number of falls. Interview T0, T1, T2, T3
 Anthropometry Weight, height, body mass index, waist and hip circumference.   T0, T1, T2, T3
 Bioimpedance % fat; % muscle Tanita BC 420S MA bioimpedance analyser T0, T1, T2, T3
 Blood pressure Systolic and diastolic blood pressure; heart rate. OMRON M6 comfort T0, T1, T2, T3
 Activities of Daily Living   6-item questionnaire T0, T1, T2, T3
 Self-rated health and health-related quality of life   SF-12
EUROQOL-5D
ICECAP-O
T0, T1, T2, T3
 Anxiety   HADS T0, T1, T2, T3
 Depressive symptoms   HADS T0, T1, T2, T3
 Social network   Lubben Social Network Scale-6 T0, T1, T2, T3
 Physical activity self-regulation   12-item Physical Activity Self-Regulation Scale T0, T1, T2, T3
 Self-efficacy for exercise   Marcus’s Self-Efficacy Questionnaire T0, T1, T2, T3
 Disability   Short form Late Life Function and Disability Index T0, T1, T2, T3
 Fear of falling   Short Falls Efficacy Scale – International T0, T1, T2, T3
 Loneliness   Short form De Jong Gierveld Loneliness Scale T0, T1, T2, T3
 Executive function   Trail Making Test T0, T1, T2, T3
 Physical fatigue   Pittsburg Fatigability Scale T0, T1, T2, T3
In a subsample:
 Level of frailty-associated biomarkers and inflammation IL-6, hsCRP, TNF-alpha, IGF-1. Blood sample T0, T1
 Sarcopenia-associated markers of muscle quality Myostatin, IL-6, IL-8, IL-15, VEGF, BDNF, FGF21, irisin, myostatin, Type 2/Type 1 fibre ratio, Wnt and Notch signaling, CDC42 Muscle biopsy T1
  1. aAssessment time points: T0 = baseline pre-intervention, T1 = at month 4 post intervention, T2 = at month 16 (12 months after the end of the intervention), and T3 = at month 22 (18 months after the end of the intervention)
  2. SPPB Short Physical Performance Battery, ICECAP-O ICEpop CAPability measure for Older people, HADS Hospital Anxiety and Depression Scale