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Table 2 Overview of indicators, methods, and time points of data collection

From: Effect, process, and economic evaluation of a combined resistance exercise and diet intervention (ProMuscle in Practice) for community-dwelling older adults: design and methods of a randomised controlled trial

   

-T1 (Enrolment)

T0 (week 0)

T1 (week 12)

T2 (week 2)4

T3 (week 3)6

T4c (week 52)

Enrolment

Indicators

Method

 

INTa

CONb

INT

CON

INT

CON

INT

CON

INT

CON

  

Informed consent

X

          

Eligibility screen

Frailty stated

Fried frailty criteria [19], medical questionnaire, additional screening questionnaire (optional)

X

          

Allocation

   

X

X

        

Outcomes

Indicators

Method

           

Socio-demographics

Age, gender, education, ethnic background, marital status, job status, smoking

Participant questionnaire [21]

 

X

X

        

Disease history

Participant questionnaire [21]

 

X

X

        

Height

Stadiometer

 

X

X

        

Nutritional statusd

SNAQ [20]

X

          

Olfactory function

Sniffin’ sticks [22]

 

X

X

        

Meal functionalities

Questionnaire [23]

 

X

X

        

Overall

Quality of life

EQ-5D-5L [25]e

 

X

X

X

X

X

X

X

X

X

X

Long-term

Physical functioning / fitness

SPPB [27], TUG [28, 29], 6MWT [30]

 

X

X

X

X

X

X

X

X

X

X

Basic Lower Extremity function questionnaire [32]

 

X

X

X

X

X

X

 

X

  

Lower extremity strength

3-RM on leg press and leg extension

 

X

X

X

X

      

Knee extension with hand held dynamometer (MicroFET)

 

X

X

X

X

X

X

X

X

X

X

Body composition (lean mass, fat mass, hydration status) and weight

DXA, BIS

 

X

X

X

X

X

X

    

Weighing scale

 

X

X

X

X

X

X

X

X

X

X

Social participation

Social Role Domain questionnaire [36]

 

X

X

X

X

X

X

 

X

  

Intermediate

Dietary / protein intake

3-day food diaries

 

X

X

X

X

X

X

 

X

  

Urinary nitrogenf

 

X

X

X

X

X

X

    

Physical activity

LAPAQ [37]

 

X

X

X

X

X

X

 

X

  

Actigraphg

 

X

X

        

Initial

Behavioural determinants

Participant questionnaire (based on [38,39,40,41,42,43,44,45])

 

X

X

X

X

X

X

    
  1. aIntervention participants
  2. bControl participants
  3. cOnly in Epe, Ermelo/Putten, and Harderwijk
  4. dMeasured during screening
  5. eAlso collected through regular post at T0.5 (week 6) and T1.5 (week 18)
  6. fCollected once at one of the time points for each participant, not collected in Apeldoorn
  7. gCollected in a random subsample of participants