Effects of continuous moderate exercise with partial blood flow restriction during hemodialysis: A protocol for a randomized clinical trial

Rodrigo Kohn Cardoso,Aline Machado Araujo,Rafael Bueno Orcy,Maristela Bohlke,Jean Pierre Oses,Fabrício Boscolo Del Vecchio,Franklin Correa Barcellos,Maria Cristina Gonzalez,Airton José Rombaldi

doi:10.1016/j.mex.2019.01.005

Rodrigo Kohn Cardoso, Aline Machado Araujo + Show 7 more

Open Access

https://doi.org/10.1016/j.mex.2019.01.005

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Abstract

Chronic kidney disease (CKD) is associated with physical weakness and increased oxidative stress and inflammation levels. Rehabilitation programs are associated with an improvement in the functional capacity, inflammatory and oxidative stress profile. Exercise associated with blood flow restriction (BFR) has been demonstrating positive effects in training programs, but there is lack information about exercise with BFR in CKD. Therefore, the aim of the present study is to describe a protocol using continuous moderate exercise with blood flow restriction (BFR) applied during hemodialysis (HD) to measures health indicators and immune system and oxidative stress parameters in CKD patients. Methods: A RTC will be conducted with 42 patients in HD. Baseline measures will be compared with final measures (anthropometric, cardiorespiratory, biochemical, muscle fitness, nutritional and behavioral questions). Participants will be randomly allocated to: 1) Continuous moderate exercise group with BFR; 2) Continuous moderate exercise group without BFR; 3) Control group without exercise. The intervention will be 12 weeks long during HD session. Patients will perform 20 min of continuous moderate exercise on a stationary bicycle three times a week. The present study is expected to generate significant information about the role of exercise with BFR in patients with CKD during HD.

Highlights

Rehabilitation programs are associated with an improvement in the functional capacity, inflammatory and oxidative stress profile.2] Exercise associated with blood flow restriction (BFR) has been demonstrating positive effects in training programs, but there is lack information about exercise with BFR in Chronic kidney disease (CKD) [3,4,5]
A cycle ergometer will be placed in front of the patient's chair and will be positioned at a distance allowing a relative knee angle between 150 and 155 and using the following progression: Mesocycle 1 – Weeks 1 to 6: participants will cycle at an intensity eliciting HR between 60 and 63% of HRmax or 10 to 11 in the perceived subjective exertion (PSE) scale, which ranges from 6 to 20 [16]
Studies aimed to verify the effects of exercise on patients submitted to HD are not new in the scientific literature

Summary

Design

An experimental randomized controlled trial (RCT), open-label, phase III-type study will be conducted, the SPIRIT (Standard Protocols Items: Recommendations for Interventional Trials) recommendations were followed, to evaluate the effectiveness of the BFR intervention. Subjects will be recruited at the nephrology department, all chronic patients of the unit who is on hemodialysis treatment will be investigated in your medical records and basic information will be analyzed allowing the application of some exclusion criteria. Afterward, they will be individually interviewed and only who fill all criteria to be included, invited to participate in the study. The randomization process will be performed using the generation of random numbers in the Stata software, version 13, and the researcher who will carry out the process will be blinded regarding to the study objectives. 14 patients will be drawn in each block to ensure balance between groups

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