IRCT20230306057633N2 IRCT 2023-05-15 Riphah International University Faisalabad Effects of calisthenic exercises and isometric exercises on diabetic patients with knee osteoarthritis Comparative effects of calisthenic exercises and isometric exercises on pain, balance and functional disability in diabetic patients with Knee Osteoarthritis 2023-03-05 anticipated 50 Complete https://irct.ir/trial/69267 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we employed a method of randomization known as simple randomization. The unit of randomization was the individual participant. To facilitate the randomization process, we utilized computer software specifically designed for this purpose. The software generated a random sequence of treatment assignments based on the predetermined block sizes and strata. The random sequence was built using established algorithms that ensure the generation of pseudorandom numbers. Pseudorandom numbers appear to be random but are generated using deterministic algorithms. To maintain allocation concealment, a crucial aspect of the randomization process, the treatment assignments were concealed from the researchers involved in participant enrollment and assignment. This was achieved by utilizing a centralized system or a secure database that stored the randomization sequence and assigned treatment codes or labels to participants in a manner that was not accessible to the researchers. This ensured that neither the researchers nor the participants knew the treatment assignment until after enrollment, reducing the potential for selection bias, Blinding description: Developing a blinding protocol: The researchers will develop a detailed blinding protocol that outlines the procedures for blinding assessors, such as ensuring that they do not have access to information that could reveal the treatment allocation. Selecting assessors: The researchers will carefully select the assessors who will be responsible for evaluating the study's outcomes. These assessors will be trained to perform their evaluations without knowledge about the treatment allocation. Concealing treatment allocation: The researchers should conceal the treatment allocation from the assessors to prevent any biases arising from knowledge of the treatment. This can be achieved by using coded or unlabeled treatments, using a separate team to manage treatment allocation, or using blinding procedures such as sham treatments or placebo. Monitoring for unblinding: The researchers will monitor the study carefully to ensure that assessors are not inadvertently unblinded, such as through conversations with other study personnel or participants. Analyzing data: Once the study is complete, the researchers should analyze the data in a blinded manner to prevent any biases arising from knowledge of the treatment allocation. N/A Knee Osteoarthitis. Intervention 1: Intervention group 1: will receive Callisthenic Exercises. Calisthenics is a form of exercise that uses a person's body weight and requires little to no equipment. Here are many health benefits to calisthenics, and most people can start exercising right away. Participants will receive 3 sets of 15 repetitions with 5 seconds rests between the sets. This treatment session will continue for 3 sessions per week for 4 weeks. Hence participants will get total 12 sessions. Intervention 2: Intervention group 2: will receive Isometric Exercises. Isometric exercises are tightening (contractions) of a specific muscle or group of muscles. During isometric exercises, the muscle doesn't noticeably change length. Participants will receive 3 sets of 15 repetitions with 5 seconds rests between the sets. This treatment session will continue for 3 sessions per week for 4 weeks. Hence participants will get total 12 sessions. No - There is not a plan to make this available Justification or reason for not sharing IPD is Our decision not to share deidentified IPD in this study is based on several factors. First and foremost, ensuring the privacy and confidentiality of the study participants is of utmost importance to us. We take data protection and ethical considerations seriously, and we believe that releasing individual-level data could potentially compromise the anonymity and confidentiality of the participants. Furthermore, there may be legal and regulatory constraints that prevent us from sharing the deidentified IPD. These constraints could be related to data protection laws, patient consent requirements, or specific agreements with the participants or institutions involved in the study.