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Table 2 Example template of recommended content for the schedule of enrolment, interventions, and assessments*

From: Physiological stress in safer cycling in older age (SiFAr-stress): effect of a multicomponent exercise intervention—a study protocol for a randomized controlled trial

 

Study period

Enrolment baseline

Intervention period

Post-allocation

Timepoint**

T0

tr2

tr7

T1

T2

Enrollment

     

Eligibility screen

X

    

Informed consent

X

    

Allocation

X

    

Study arms

     

Intervention group

X

X

X

X

X

Active control group

X

  

X

X

Assessments

     

Sociodemographic characteristics

X

    

Weight/height/BMI

X

  

X

X

Health parameters (medication, diseases)

X

  

X

X

Cognitive function (MoCA, TMT A&B)

X

  

X

X

Performance in the cycle course

X

  

X

X

Physical performance (SPPB)

X

  

X

X

Quality of life (EuroQoL-5D + VAS)

X

  

X

X

Falls/fear of falling (FES-I short form)

X

  

X

X

Bicycle-related Parameters (cycled distance, self-reported cycling behavior)

X

  

X

X

Biological specimen

     

Saliva samples

X

3x1

3x1

X

X

CRP (capillary blood sample)

X

  

X

X

Hair sample

X

  

X

X

  1. MoCA Montreal-Cognitive Assessment, TMT Trail Making Test, SPPB Short Physical Performance Battery, VAS visual analog scale, FES-I Falls Efficacy Scale-International Version, CRP C-reactive protein
  2. 1Saliva samples only for intervention group