Table 2 Measures of feasibility for assessment strategy, monitoring and methodology of study protocol
Metrics | Monitoring and strategy | Method of assessment |
|---|---|---|
Process -Recruitment and retention | -Recruitment and retention rate - Retention & attrition | The participants were recruited using telephone calls, email, word of mouth promotion, and brochures. The potential participants were entered into Excel software. In addition, the subjects recruitment flow and program section were input in Excel software. |
Resources -Monetary and communication needs of the study | - Communication with participants - Costs of research | All connections with participants were added to Microsoft Excel. There were not any connection challenges during the six weeks of treatment. - All the expenses of the study was calculated. |
Management - Safety report and data management of the study. | -SKU approval procedures - Preparing the staff and report time for participant communication - accuracy and time in data collection/entry | - All communications between staff and BMSU and time gap between MBSU submission and approval were - All call time, preparation, and time of taking reports during the program were input in Excel. - Additional data such as record time to collect, completeness, enter, and check data was added into Microsoft Excel. |
Scientific -Safety, burden, adherence, experience, and treatment effect | - Serious adverse events (SAE)handling and reporting adverse events (AE), and clinical emergencies - Clinical emergencies, AEs, and SAEs. - Adherence, participants’ burden, and experience in the program - Treatment effect | - The subjects were required to record and report medical issues to the coaches. In addition there were required to fill out a questionnaire about their history of exercise treatments. The provided answers were recorded. -The subject reported their adverse events, exercise sessions, and experiences in log books for further discussion during the visits. - The clinical meaningfulness and effect size of any change in functional, biochemical, and cognitive outcomes were determined. |