Investigating The Effect of Inspiratory Muscle Training during Hemodialysis On Pulmonary Function, Sleep Quality And Quality of Life In End Stage Renal Disease Patients With Overload: A Randomized Clinical Trial

Determine The Effect of Inspiratory Muscle Training during Hemodialysis On Pulmonary Function, Sleep Quality And Quality of Life In End Stage Renal Disease Patients With Overload

A controlled, parallel-group, single-blind, randomized trial, phase 2 clinical trial on 60 patients. The website https://www.sealedenvelope.com will be used for randomization.

The study will be conducted at Shahid Jalil Hospital, Yasuj. The intervention will be performed for 2 weeks using the SpiroXpert, a proprietary, pitot tube designed by SpiroXpert, proprietary designed pitot tube, floXpert, Iran . The study is single-blind. Due to the nature of the intervention (tail muscle exercises during hemodialysis), patients are aware of the intervention and there is no possibility of blinding them. However, in order to reduce bias in the evaluation of the results, the assessor responsible for measuring the outcome variables will be unaware of the allocation of patients to the intervention or control group.

Inclusion: The patient must have a history of dialysis for at least three months. The patient must have fluid overload. No cancer. Exclusion: Pregnancy and acute lung infection

After Random Assignment To Two Intervention And Control Groups, The Intervention Group Will Undergo Intervention Using A Tailbone Strengthening Device Twice A Week For 6 Weeks. The Control Group Will Receive Standard Treatment.

Pulmonary Function; Quality of Life; Sleep Quality

The blocking method will be used to allocate individuals to the study groups. The advantages of blocked randomization are that the balance of the number of patients in each group is guaranteed. The groups are defined as codes A and B. Group A will be considered the intervention and group B the control. Before assigning individuals to one of the groups, a list of letters (A, B) in the form of blocks will be formed. This random assignment list will be formed by the reputable website https://www.sealedenvelope.com. Each of the referring and eligible individuals will be assigned to one of the groups according to the created list. To prevent the predictable risk of assigning individuals to different groups, blocks of different sizes (2; 4; 6 and 8) will be created. Blocks of two such as AB - blocks of four such as ABAB - blocks of six such as AABABB - blocks of eight such as ABBABABA.

The study is single-blind. Due to the nature of the intervention (tail muscle exercises during hemodialysis), patients are aware of the intervention and there is no possibility of blinding them. However, in order to reduce bias in the assessment of the results, the assessor responsible for measuring the outcome variables will be unaware of the allocation of patients to the intervention or control group.

One Month After The Completion Of The Intervention, The Data Of The Main Variables Of The Study Will Be Shared

The Commencement Of The Access Period Is 3 Months After The Publication Of The Results.

After The Publication Of The Article, All Individuals Will Have Access To Its Content.

Individuals Associated With The Medical And Therapeutic Field May Utilize The Data From This Study To Conduct New Research

By Official Email To The Corresponding Author

The Applicant Must Submit Their Formal Request Via The Organization's Email To The Email Of The Responsible Author. The Responsible Author Will Provide The Information To The Applicant Within A Maximum Of Two Weeks Upon Confirmation Of The Information