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Table 1 Feasibility outcomes of the study

From: An augmented prescribed exercise program (APEP) to improve mobility of older acute medical patients – a randomized, controlled pilot and feasibility trial

Outcome

Description

Operationalization and unit

Feasibility of the processes and the study design that are key to the success of the main study

 Recruitment rate

Rate between older acute medical inpatients admitted during the study period and study participants

n participants/n inpatients [%]

 Recruitment time

Time needed to recruit 30 participants

Time [weeks]

 Refusal rate

Rate between inpatients declining to participate and eligible inpatients

n refusing inpatients/n eligible inpatients [%]

 Retention rate

Rate between study drop-outs and study participants

n drop-outs/n of participants included [%]

 Eligibility criteria

Is it obvious who meets and who does not meet the eligibility requirements?

n of unclear cases

Are the eligibility criteria sufficient or too restrictive?

Sufficient if recruitment rate > 10%

 Randomization

Comparability of randomized groups (blocks of 8 without stratification)

Primary clinical endpoint (de Morton Mobility Index): Assessment of statistical differences between intervention and control group at baseline (2-sided t-test)

Feasibility of the outcome measures

 Safety

Number of adverse events during study assessments

Total n

 Duration

Length of time to fill out all the study forms

Time in minutes; number (rate) of assessment sessions completed within one single session

 Acceptance

Number of refused outcome measures

Total n

 Completeness

Number of missing items per outcome measure

Total n

 Interpretability

floor or ceiling effects

≥15% of participants are not able to perform an outcome measure; ≥15% of participants score the lowest or highest score of a scale

Resource problems that can occur during the main study

 Equipment

Is the equipment readily available when and where it is needed?

Number of issues with assessment equipment, such as break downs, shortage of equipment

 Center willingness and capacity

Do the clinical centers do what they committed to do?

Number of issues with workflows; number of capacity issues

Feasibility and acceptability of the APEP intervention and adherence to the exercise protocol

 Amount

Frequency

n of sessions per participant; mean n of sessions per weak

Duration

Mean duration of sessions [min]

 Compliance

Rate of scheduled and completed sessions

N sessions completed / n sessions scheduled (%)

 Intensity

Participant’s subjective rating of perceived exertion assessed

Mean perceived exertion after each session [BORG scale score]

 (Non)compliance or adherence rate

Rate between intervention group participants who perform at least 75% of planned APEP intervention sessions and all intervention group participants

n of intervention group participants who perform at least 75% of planned APEP intervention sessions/n intervention group participants [%]

 Safety

Adverse events (moderate, or severe) caused not, probably caused, likely caused or surely caused by the intervention

Total n

 Acceptability

Motivation

Mean motivation of participant’s to perform additional physiotherapy sessions (APEP) [numeric rating scale score; 0–10 points]

Recovery

Mean participant’s recovery prior to additional physiotherapy sessions (APEP) [numeric rating scale score; 0–10 points]

 Costs

Delivery of APEP intervention

Costs [€] for all actually planned and delivered APEP sessions

  1. Abbreviations: n = number, APEP = augmented prescribed exercise program