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Justifying sample size for a pilot trial is a reporting requirement, but few pilot trials report a clear rationale for their chosen sample size. Unlike full-scale trials, pilot trials should not be designed to test effectiveness, and so, conventional sample size justification approaches do not apply. Rather, pilot trials typically specify a range of primary and secondary feasibility objectives. Often, these objectives relate to estimation of parameters that inform the sample size justification for the full-scale trial, many of which are binary. These binary outcomes are referred to as "feasibility outcomes" and include expected prevalence of the primary trial outcome, primary outcome availability, or recruitment or retention proportions. For pilot cluster trials, sample size calculations depend on the number of clusters, the cluster sizes, the anticipated intra-cluster correlation coefficient for the feasibility outcome and the anticipated proportion for that outcome. Of key importance is the intra-cluster correlation coefficient for the feasibility outcome. It has been suggested that correlations for feasibility outcomes are larger than for clinical outcomes measuring effectiveness. Yet, there is a dearth of information on realised values for these correlations. In this tutorial, we demonstrate how to justify sample size in external pilot cluster trials where the objective is to estimate a binary feasibility outcome. We provide sample size calculation formulae for a variety of scenarios, make available an R Shiny app for implementation, and compile a report of intra-cluster correlations for feasibility outcomes from a convenience sample. We demonstrate that unless correlations are very low, external pilot cluster trials can be made more efficient by including more clusters and fewer observations per cluster. [ABSTRACT FROM AUTHOR]

Background: Fussy eating is most often a developmentally typical behaviour, generally presenting during toddlerhood. However, up to half of parents of young children are concerned about fussy eating, and this concern may mediate the use of nonresponsive feeding practises, such as coercive or unstructured feeding and using food to reward eating. Despite the high prevalence of parental concern for fussy eating and the negative impacts nonresponsive feeding practises have on children's health and diets, no previous digital intervention to improve the feeding practises of parents of toddlers concerned about fussy eating has been evaluated. Aim: This article describes the protocol of a randomised controlled feasibility pilot aiming to evaluate Fussy Eating Rescue, a purely web app based intervention for parents of toddlers. The primary aim is to investigate feasibility and acceptability; secondary aims are to explore indications of intervention effect on parents' feeding practises or children's eating behaviours. Methods: Fussy Eating Rescue features include: (1) a Tracker, that allows parents to track repeated offers of food, (2) Topics, providing information on fussy eating, effective feeding strategies, and general nutrition, (3) Rescues, containing quick references to material supporting Topics contents, (4) Recipes, and (5) SMS notifications. Parents of toddlers (12–36 months old, n = 50) who have concerns about fussy eating will be recruited via Facebook. Parents will be randomised to an intervention group, which receives access to the app for 6 weeks, or to wait-listed control. Outcomes will be assessed at baseline and 6 weeks after app use, using online questionnaires and app usage statistics. Primary outcomes include participant retention rate, intervention engagement, app usability, perceived ease in using the app, perceived usefulness of the app, and user satisfaction. Secondary outcome measures include parents' feeding practises and children's eating behaviours. Discussion: Results will inform whether Fussy Eating Rescue is a feasible way to engage parents concerned for their toddler's fussy eating behaviours. If feasible and acceptable to users, a larger trial will further examine the efficacy of the Fussy Eating app in improving parents' feeding practises and children's eating behaviours. Trial registration: Prospectively registered with the Australian New Zealand Clinical Trials Registry on 15 July, 2021 (ACTRN12621000925842). [ABSTRACT FROM AUTHOR]

Background: To assess the clinical feasibility of a virtual mirror therapy system in a pilot sample of patients with phantom pain. Methods: Our Mixed reality system for Managing Phantom Pain (Mr. MAPP) mirrors the preserved limb to visualize the amputated limb virtually and perform exercises. Seven patients with limb loss and phantom pain agreed to participate and received the system for 1-month home use. Outcome measures were collected at baseline and 1 month. Results: Four (of seven recruited) participants completed the study, which was temporarily suspended due to COVID-19 restrictions. At 1 month, in-game data showed a positive trend, but pain scores showed no clear trends. Functioning scores improved for 1 participant. Conclusions: Mr. MAPP is feasible and has the potential to improve pain and function in patients with phantom pain. Trial registration: Clinical Trials Registration, NCT04529083 [ABSTRACT FROM AUTHOR]

Background: Evidence from observational studies have shown that moderate intensity physical activity can reduce risk of progression and cancer-specific mortality in participants with prostate cancer. Epidemiological studies have also shown participants taking metformin to have a reduced risk of prostate cancer. However, data from randomised controlled trials supporting the use of these interventions are limited. The Prostate cancer–Exercise and Metformin Trial examines that feasibility of randomising participants diagnosed with localised or locally advanced prostate cancer to interventions that modify physical activity and blood glucose levels. The primary outcomes are randomisation rates and adherence to the interventions over 6 months. The secondary outcomes include intervention tolerability and retention rates, measures of insulin-like growth factor I, prostate-specific antigen, physical activity, symptom-reporting, and quality of life. Methods: Participants are randomised in a 2 × 2 factorial design to both a physical activity (brisk walking or control) and a pharmacological (metformin or control) intervention. Participants perform the interventions for 6 months with final measures collected at 12 months follow-up. Discussion: Our trial will determine whether participants diagnosed with localised or locally advanced prostate cancer, who are scheduled for radical treatments or being monitored for signs of cancer progression, can be randomised to a 6 months physical activity and metformin intervention. The findings from our trial will inform a larger trial powered to examine the clinical benefits of these interventions. Trial registration: Prostate Cancer Exercise and Metformin Trial (Pre-EMpT) is registered on the ISRCTN registry, reference number ISRCTN13543667. Date of registration 2nd August 2018–retrospectively registered. First participant was recruited on 11th September 2018. [ABSTRACT FROM AUTHOR]

Background: While the underlying neuropathology of dementia is not curable, interventions and treatment, such as physical activity, can offer physical and functional gains leading to better mobility, independence and quality of life. The Seniors Exercise Park program is an evidence-based physical and social activity program using an innovative design in outdoor exercise equipment specifically designed for older people. This unique program has never been tested with older people living with dementia. This study will evaluate the feasibility of delivering the Seniors Exercise Park program for people living with mild to moderate dementia in residential aged-care. This study will identify the optimal physical activity program, evaluate the safety of equipment usage and determine optimal supervision needs. The potential physical, social, quality of life and cognitive benefits of participation in the Seniors Exercise Park program will also be examined. Methods: This is a feasibility pilot randomised controlled design with pre-post evaluation. Adults aged ≥ 60 years who have symptoms of dementia and/or who have been diagnosed with dementia will be recruited from an aged-care facility in Melbourne. Participants allocated to the intervention group will undergo a 12-week structured supervised physical activity program using the outdoor Seniors Exercise Park equipment followed by a 12-week maintenance phase (unstructured physical activity). Participants will be assessed at baseline, 3 and 6 months. Participants allocated to the control group will attend activities provided by the aged-care facility. A sample of 12 participants per group is the targeted sample size. Feasibility will be evaluated in terms of recruitment rate, retention, attendance, overall adherence, dropout rate, adverse events, modifications to the exercise program delivery and supervision needs. A comprehensive suite of cognitive and health-related questionnaires and physical function measures will also be collected. Discussion: The ENJOY program for independence in dementia will determine the suitability of the Seniors Exercise Park program for people diagnosed with mild to moderate dementia. Outcomes could inform future design of dementia-friendly built environments to increase physical activity participation for residential aged-care facilities. Trial registration: This trial is registered with the Australian New Zealand Clinical Trials Registry—Registry Number ACTRN12620000733976. Registered on the 13th of July 2020. [ABSTRACT FROM AUTHOR]

Background: While the underlying neuropathology of dementia is not curable, interventions and treatment, such as physical activity, can offer physical and functional gains leading to better mobility, independence and quality of life. The Seniors Exercise Park program is an evidence-based physical and social activity program using an innovative design in outdoor exercise equipment specifically designed for older people. This unique program has never been tested with older people living with dementia. This study will evaluate the feasibility of delivering the Seniors Exercise Park program for people living with mild to moderate dementia in residential aged-care. This study will identify the optimal physical activity program, evaluate the safety of equipment usage and determine optimal supervision needs. The potential physical, social, quality of life and cognitive benefits of participation in the Seniors Exercise Park program will also be examined. Methods: This is a feasibility pilot randomised controlled design with pre-post evaluation. Adults aged ≥ 60 years who have symptoms of dementia and/or who have been diagnosed with dementia will be recruited from an aged-care facility in Melbourne. Participants allocated to the intervention group will undergo a 12-week structured supervised physical activity program using the outdoor Seniors Exercise Park equipment followed by a 12-week maintenance phase (unstructured physical activity). Participants will be assessed at baseline, 3 and 6 months. Participants allocated to the control group will attend activities provided by the aged-care facility. A sample of 12 participants per group is the targeted sample size. Feasibility will be evaluated in terms of recruitment rate, retention, attendance, overall adherence, dropout rate, adverse events, modifications to the exercise program delivery and supervision needs. A comprehensive suite of cognitive and health-related questionnaires and physical function measures will also be collected. Discussion: The ENJOY program for independence in dementia will determine the suitability of the Seniors Exercise Park program for people diagnosed with mild to moderate dementia. Outcomes could inform future design of dementia-friendly built environments to increase physical activity participation for residential aged-care facilities. Trial registration: This trial is registered with the Australian New Zealand Clinical Trials Registry—Registry Number ACTRN12620000733976. Registered on the 13th of July 2020. [ABSTRACT FROM AUTHOR]