Here is the design of a clinical trial:

Official Title: PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery - The PROTECT-CS Study

Included conditions:
- Frail Older Adult Syndrome
- Nutrition Poor
- Cardiovascular Morbidity

Study Armgroups:
- {'label': 'Protein Supplementation', 'type': 'EXPERIMENTAL', 'description': 'The intended intervention consists of a leucine-rich protein-caloric supplement provided by the Enhanced Medical Nutrition®. The product contains 25 g protein and 3 g Leucine per serving (total caloric value: 160 Kcal.) to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home (Appendix A).', 'interventionNames': ['Dietary Supplement: ISOlution protein supplement']}
- {'label': 'Placebo Supplementation', 'type': 'PLACEBO_COMPARATOR', 'description': 'Enrolled patients allocated to the control group will receive the same supplementation schedule as well as compliance verification; however, they will receive a placebo product with no supplemented protein (no nutritional benefit).', 'interventionNames': ['Dietary Supplement: Placebo Supplement']}

Interventions:
- {'type': 'DIETARY_SUPPLEMENT', 'name': 'ISOlution protein supplement', 'description': 'EXPERIMENTAL ARM: Protein supplement to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home.', 'armGroupLabels': ['Protein Supplementation']}
- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo Supplement', 'description': 'PLACEBO COMPARATOR ARM: Placebo supplement to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home', 'armGroupLabels': ['Placebo Supplementation']}

Primary Outcomes:
- {'measure': 'Change in Short-Form 36 physical Function (PF) score', 'description': 'The SF-36 PF assessment captures the physical functioning of participants. It has been moderately correlated with the SPPB and can be used interchangeably if the SPPB is not able to be completed by a patient', 'timeFrame': 'Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery'}

Please estimate the sample size based on the assumption: 
The study assumes a two-tailed alpha of 0.05, a power of 80%, and an overall drop-out rate of 15%.
Sample size
        Based on a previously observed distribution of SPPB scores in our elective cardiac surgery population, we expect this effect size will be approximately equivalent to either a 1-point change in the SPPB score or a 10-point change in SF-36-PF score. This magnitude of change in SPPB score is associated with aâsubstantialâ improvement in mobility and quality of life,27 and survival.62 Furthermore, the scale of change for the SF-36-PF is sensitive to detect even a small and clinically meaningful change in physical functioning.63 Due to the global pandemic (COVID-19), research initiatives that collected data through in-person meetings were suspended on two occasions (March 2020âAugust 2020, and November 2020âTBD). As a result, we developed an alternative primary outcome (ie, SF-36-PF) to implement for the trial in order to accommodate the institutional directive to transition research to use remote/virtual data collection strategies. The SF-36-PF is an optimal outcome measure appropriate for our study cohort, as it is correlated with the SPPB (r=0.5â0.6) and is a surrogate measure of physical function.51 A sample size of 150 patients (75 in each group) will allow for an overall drop-out rate of 15% (n=22) while maintaining a moderate Cohenâs effect size (0.5) to detect the difference in change experienced between the two experimental groups at each follow-up time point with a two-tailed alpha of 0.05 and a power of 80% for the continuous primary outcomes. G*Power V.3.1 was used to calculate sample size for this study.