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Table 2 Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) diagram to show the participant schedule, including enrolment, allocation, interventions, visits, and assessments [20]

From: A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): protocol for a randomised controlled feasibility study

  Study period
Recruitment Baseline Allocation Post-allocation Close-out
Visit Pre-enrolment Visit 1 Allocation between visit 1 and 2 Visit 2 Visit 3 PC 1 PC 2 PC 3 Visit 4 Visit 5 Post-study
Timepoint (weeks) 1 2 3 3 3 5 7 9 1 week prior to surgery 6 weeks post-surgery  
Study member Research nurse R Third party R R R R R R R R
Enrolment
 Eligibility screening X           
 Informed Consent   X          
 Allocation    X         
Study groups
 Sedentary behaviour reduction X X X X X X X X X X  
 Regular care X X X       X X  
Assessments
 Feasibility (study statistics)            X
 Feasibility (interviews with research nurses)            X
 Feasibility (questionnaire, acceptability, practicality, adaption, satisfaction, safety)          X X  
 Socio-demographic questions (age, gender, ethnicity, prior occupation, country of origin, educational level, pet ownership, marital status, living arrangements, alcohol frequency smoking frequency, medication info, medical history)   X          
 activPAL measurements (sitting time, sit-to-stand transitions, no. of sedentary bouts ≥ 30 mins, avg. length of sedentary bouts, stepping time, standing time, steps per day)   X        X X  
 International Physical Activity Questionnaire–Short Form (IPAQ-SF) [39]   X        X   
 Measure of older adults’ sedentary behaviour (MOST) [40]   X        X X  
 Quality of life (QoL) (EuroQoL 5D-5L, EuroQoL Visual Analogue Scale) [41]   X        X X  
 Oxford Hip and Knee Score(s) [42, 43]   X        X X  
 Basic Psychological Needs Scale [25, 26]   X        X X  
 Activities of daily living (ADL) (Katz-ADL) [37]   X        X   
 Physical function–Short Physical Performance Battery (SPPB) [36]   X        X X  
 Short Form Mini Nutritional Assessment (SF-MNA) [37]   X          
 Weight   X        X X  
 Height   X          
 Body mass index   X        X X  
 Waist-to-hip ratio   X        X   
 Albumin, high-density lipoprotein, low-density lipoprotein, cholesterol, triglycerides, vitamin D, cortisol, transferrin, HBA1c, CRP, full blood count   X        X   
  1. R researcher, PC phone call, CRP C-reactive protein
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Pilot and Feasibility Studies

ISSN: 2055-5784