Randomization will be done with 12 blocks, each including three persons, and involves a structured process to ensure unbiased and balanced allocation of participants to different study groups.
Here is a detailed description of this randomization process:
1. Blocks Formation:
Creating 12 blocks, each with three slots for participants.
2. Random Sequence Generation:
Using a random number generator to create a sequence assigning blocks to either the intervention (I) or control (C) group.
Example: I, C, I, C, I, C, I, C, I, C, I, C.
3. Assignment Process:
A person blind to group details assigns blocks according to a random sequence.
Example Assignments:
Block 1: I, Block 2: C, Block 3: I, and so on.
4. Participant Allocation:
Participants are enrolled sequentially and placed into the next available slot in the current block.
Example: Participants 1-3 in Block 1 (I), Participants 4-6 in Block 2 (C), etc.
5. Ensuring Balance:
6 blocks for intervention and 6 for control ensure equal group sizes (18 participants each).
Small block size maintains balance throughout enrollment.
This structured randomization process ensures unbiased, balanced allocation of participants to study groups, enhancing the reliability and validity of the study outcomes.
In this study, the patients in both groups engage in the same aerobic and strength exercises, receive identical nutrition advice, and are provided with exercise elastic bands for their resistance workouts.
However, the intervention group has an additional element in their regimen: starting from the second week, they receive a creatine supplement. The control group does not receive this supplement.
Participants are aware of interventions, they complete the consent form and in the consent form, we explain the trial process and describe interventions in both groups.
In addition, in this study principal investigator and the assessor are unaware of the participants' group assignments. This reduces the risk of bias in the administration of the intervention and the assessment of outcomes. A third person, who is not involved in any aspect of patient interaction or assessment, performs the randomization and manages the allocation of participants to either the intervention or control group. This person ensures the sequence and assignment remain confidential and strictly adheres to the randomization protocol to maintain the study's validity and reliability.