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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