Comparative effects of calisthenic exercises and isometric exercises on pain, balance and functional disability in diabetic patients with Knee Osteoarthritis

The aim of this study is to compare the effects of calisthenic exercises and isometric exercises on pain, balance and functional ability in diabetic patients with Knee Osteoarthritis

Randomised, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site. That external site will be Research Randomizer software (https://www.randomizer.org/).

Study will be conducted at Allied Hospital Faisalabad and Outcome assessor, who was a serving physiotherapist in hospital, will be blinded

Inclusion Criteria: Both male and female Age between 35 to 60 Inter-articular knee joint pathology Diagnosed osteoarthritis Grade 1 to 4 osteoarthritis Exclusion Criteria: History of lower extremity traumatic injury Any neurological deficits of the lower extremity History of any fracture or surgery on the lower extremity.

Intervention group 1: will receive callisthenic exercises. Callisthenic exercises, also known as bodyweight exercises, are a form of physical activity that uses the own body's weight to provide resistance and build strength, flexibility, and endurance. These exercises can be performed without the need for equipment or weights, making them accessible and convenient for individuals of all fitness levels. Intervention group 2: will receive the hold relax technique. The "hold relax" technique, also known as proprioceptive neuromuscular facilitation (PNF) stretching, is a method used to increase flexibility and improve the range of motion in specific muscle groups. It involves a combination of stretching and muscle contraction to achieve greater gains in flexibility compared to traditional static stretching.

Knee joint pain; Knee joint range of motion

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.

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.

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.