Here is the design of a clinical trial:

Official Title: Neuromuscular Electrical Stimulation for Physical Function Maintenance During Hematopoietic Stem Cell Transplantation

Included conditions:
- Autologous Hematopoietic Stem Cell Transplant

Study Armgroups:
- {'label': 'Active NMES', 'type': 'ACTIVE_COMPARATOR', 'description': 'asymmetric biphasic waveforms at 71 pulses per second frequency (Hz), 400 s pulse duration, 5:10s on:off time (50% duty cycle), and 1.5s ramp-up time. Participants will be in control of the muscle stimulator devices at all times and will be instructed to perform all sessions in the supine position. Bilateral NMES will be delivered via asymmetric, biphasic using four cutaneous parallel channels delivered simultaneously using 2"x4" or 3"x5" self-adhesive electrodes. For the active NMES group, participants will be encouraged to increase the amplitude to a level of moderate discomfort, such as that experienced during conventional exercise, but not to induce pain. At minimum, the amplitude should induce visible muscle contraction.', 'interventionNames': ['Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)']}
- {'label': 'Sham NMES', 'type': 'SHAM_COMPARATOR', 'description': 'The amplitude of the muscle stimulators for the Sham group will be capped at 15 milliamperes so patients will only feel cutaneous sensation without achieving muscle contraction.', 'interventionNames': ['Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)']}

Interventions:
- {'type': 'DEVICE', 'name': 'RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)', 'description': 'Active or Sham Neuromuscular electrical stimulation. US Food and Drug Administration-approved 2012', 'armGroupLabels': ['Active NMES', 'Sham NMES'], 'otherNames': ['NMES, e-stim']}

Primary Outcomes:
- {'measure': '6-Minute Walk Test', 'description': 'Manual and mobile application assessment', 'timeFrame': 'change from before to 1month after transplant'}

Please estimate the sample size based on the assumption: 
Type I error probability α = 0.05, power = 0.9, 1:1 NMES:sham participant randomization, and a 33% attrition rate.
Statistical analysis and sample size calculation
        The primary outcome is between-group difference in 6MWT change from Pre-HCT to FU1 (manual assessment). Our laboratory previously reported ~41 Â± 15m reduction in 6MWT in Autologous recipients between the same Pre and FU1 time points [31]. We expect the sham group in the current project to display a similar change, and for NMES to attenuate this change by 50%, resulting in a between-group difference in 6MWT change of -20.7 Â± 16.0m. Along with a Type I error probability Î± = 0.05, power = 0.9, and 1:1 NMES:sham participant randomization, we will need to enrol 15 minimum participants per group. This is consistent with the recent finding from Bewarder and colleagues in which a combined group of autologous/allogenic HCT patients and hematologic cancer patients undergoing intensive chemotherapy without HCT displayed a mean reduction in 6MWT of 24m after NMES [25]. We estimate a 33% attrition rate, and therefore aim to enrol 23 participants/group (46 total). Approximately 100 HCT are performed each year at the MTU at VAPSHCS with roughly 70 being autologous HCT. The enrolment rate for our prior observational trial was 20 autologous HCT recipients/year, and we estimate enrolment of 17 patients/year for this project which would allow for completion of enrolment (N = 46 total), accounting for attrition, and primary outcome (FU1) assessment 2.5â3 years after study initiation and completion of final (FU2) assessment 3â3.5 years after study initiation.
        All variables will be summarized descriptively using N, mean, and standard error using the latest version of SPSS. The study cohort will be described using Pre-HCT data, both overall and comparing between study arms using t-tests for continuous variables and X2 tests for categorical variables. Testing of statistical significance will be 2-tailed, with a p-value â¤0.05. An intent-to-treat analyses will be conducted using paired-sample t-tests for continuous variables and X2 for categorical variables for within-group comparisons of outcomes between Pre and FU1; independent t-tests will be used for between-group comparisons of change variables (FU1 minus Pre-HCT). Exploratory analyses will include multiple linear regression models to test whether Pre-HCT 6MWT is a predictor of physical function or patient-reported fatigue (FACIT-F or MJM) at FU2. The model will control for group assignment, adherence, hemoglobin, and age as well as any potential confounding variables found to be unbalanced between groups in bivariate testing described above.