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Intradialisis Physical Exercise in Quality of Life and Health

Studies

Study First Submitted Date 2021-09-22
Study First Posted Date 2022-01-26
Last Update Posted Date 2023-08-07
Start Month Year February 15, 2024
Primary Completion Month Year February 12, 2028
Verification Month Year August 2023
Verification Date 2023-08-31
Last Update Posted Date 2023-08-07

Detailed Descriptions

Sequence: 20669489
Description Objective of this study will be evaluate the effectiveness of different modalities of physical exercise about clinical health indicators and quality of life of patients with chronic kidney disease undergoing on hemodialysis. This study will include to 100 people over 18 years old who are stage five of chronic kidney disease and go to hemodialysis units of Bogota D.C, Colombia. The ransomized controlled clinical trial to clusters, with 3 groups of intervetion and 1 control, double masking. All the participants receive information on informed consent. The study was approved by the ethics committee of the Universidad del Rosario

Conditions

Sequence: 52035126
Name Chronic Kidney Diseases
Downcase Name chronic kidney diseases

Id Information

Sequence: 40051512
Id Source org_study_id
Id Value DVO005 769-CV1091

Design Groups

Sequence: 55443166 Sequence: 55443167 Sequence: 55443168 Sequence: 55443169
Group Type Experimental Group Type Experimental Group Type Experimental Group Type No Intervention
Title Cardiovascular exercise Title Muscle strength Title Mixed Title Control
Description Cycloergometer Description Strength exercises will be performed during the hemodialysis session. Description Both aerobic and muscular strength exercises will be performed. Description Conventional treatment or dyalisis usual care

Interventions

Sequence: 52347074 Sequence: 52347075 Sequence: 52347076
Intervention Type Other Intervention Type Other Intervention Type Other
Name cardiovascular exercise Name Muscle strength Name Mixed
Description Exercise that mainly stimulates the cardiovascular and respiratory systems. Description Exercise that primarily stimulates the musculoskeletal system. Description Exercise that stimulates the musculoskeletal, cardiovascular and respiratory systems.

Keywords

Sequence: 79647952 Sequence: 79647953 Sequence: 79647954 Sequence: 79647955 Sequence: 79647956 Sequence: 79647957 Sequence: 79647958
Name Chronic kidney disease Name Health indicators Name Quality of life Name Hemodialysis Name Peritoneal dialysis Name Cardiovascular exercise Name Resistance exercise
Downcase Name chronic kidney disease Downcase Name health indicators Downcase Name quality of life Downcase Name hemodialysis Downcase Name peritoneal dialysis Downcase Name cardiovascular exercise Downcase Name resistance exercise

Design Outcomes

Sequence: 176907963 Sequence: 176907964 Sequence: 176907965 Sequence: 176907966 Sequence: 176907967 Sequence: 176907968 Sequence: 176907969 Sequence: 176907970 Sequence: 176907971 Sequence: 176907972 Sequence: 176907973 Sequence: 176907974 Sequence: 176907975 Sequence: 176907976 Sequence: 176907977 Sequence: 176907978 Sequence: 176907979 Sequence: 176907980
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type other Outcome Type other Outcome Type other
Measure Health indicators – Dialysis efficiency Measure Health indicators – KT/V Measure Health indicators – Sarcopenia Measure Kidney Disease and Quality of Life (KDQOL-36) Measure Physical condition – Body composition1 Measure Physical condition – Body composition2 Measure Physical condition – Body composition3 Measure Physical condition – Body composition4 Measure Physical condition – Body composition5 Measure Muscle strength Measure Fatigue Measure Functional capacity – SPPB Measure Functional capacity -6MWT Measure Functional capacity – 2MT Measure Depression and anxiety (Beck Scale) Measure Caloric intake Measure Number of participants that Smoke Measure Prevalence of hemodialysis
Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months Time Frame 6 months
Description Dialysis efficiency will be measured by analysis through biochemical methods in blood serum (KT/V). Description It is an indicator of the rate of clearance of urea and other wastes by the dialyzer. Description Sarcopenia will be measured by means of dynamometry, in the upper limb it will be evaluated using a handgrip dynamometer Participants will be instructed to stand with their arms fully extended by gradually and continuously squeezing their grip until they reach their maximum strength for at least 2 seconds, the test will be performed twice. In lower limb will be performed by means of lower limb dynamometer in which the subject holds the center of the bar, palms down, head straight and back straight, flexes the knees at an angle of 120° and the length of the chain is adjusted so that the bar is in the crease formed between the thigh and the trunk. The subject can place his hands in the middl Description This will be measured by means of the Kidney Disease and Quality of Life Questionnaire (KDQOL-36) which is defined as a specific questionnaire for patients with kidney disease on dialysis, developed by the Kidney Disease Quality of Life Working Group as a specific self-report measure of health-related quality of life or perceived health in these individuals. It is a self-report questionnaire that combines the generic SF-36 health survey instrument and disease-specific components to assess the health-related quality of life of patients with chronic kidney disease. The minimum value is 0 and the maximum value is 100. A higher score means a better quality of life Description This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of body mass index, visceral fat percentage, total body fat and muscle percentage. Description This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of body mass index. Description This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of visceral fat percentage. Description This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of total body fat. Description This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in body muscle percentage. Description The muscle strength will be measured by means of dynamometry, in the upper limb it will be evaluated using a handgrip dynamometer Participants will be instructed to stand with their arms fully extended by gradually and continuously squeezing their grip until they reach their maximum strength for at least 2 seconds, the test will be performed twice. In lower limb will be performed by means of lower limb dynamometer in which the subject holds the center of the bar, palms down, head straight and back straight, flexes the knees at an angle of 120° and the length of the chain is adjusted so that the bar is in the crease formed between the thigh and the trunk. The subject can place his hands in the middl Description This variable will be measured by means of the Fatigue Severity Scale created by Krupp for the assessment of fatigue. It consists of 9 items with a Likert-type response with 7 possibilities, of increasing intensity and scoring between 1 and 7, the total is given with the sum of all items. Its objective is to determine the severity of fatigue in patients with renal disease. Description This variable will be measured by means of a questionnaire called Short Physical Performance Battery. The purpose of this test is to evaluate the functioning of the lower extremities in the elderly and it is applied to older adults who have the ability to transfer from sitting to standing autonomously and without the help of the upper limbs. Description The functional capacity will also be measured by means of the 6-minute test, which is defined as a constant load stress test that measures the distance a person can walk in a period of six minutes, at a fast pace, on a flat, hard surface. Description The functional capacity will also be measured by means of the two-minute stationary gait test, which consists of the individuals evaluated marching in place as fast as possible for 2 minutes; reference values have been published for adults between 60 and 94 years of age. Description This will be measured by means of the Beck Depression and Anxiety Scale. It is a self-assessment scale that primarily assesses the clinical symptoms of melancholy and intrusive thoughts present in depression. It is the one with the highest percentage of cognitive symptoms, highlighting also the absence of motor and anxiety symptoms. It is commonly used to assess the severity of the disease. Scale values range from 0 to 63, a higher score represents a worse outcome. Description Measured by means of the intake diary Description Assessed by means of surveys. Absence or presence of smoking habit Description Assessed by clinical history.

Browse Conditions

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Mesh Term Kidney Diseases Mesh Term Renal Insufficiency, Chronic Mesh Term Urologic Diseases Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Male Urogenital Diseases Mesh Term Renal Insufficiency Mesh Term Chronic Disease Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term kidney diseases Downcase Mesh Term renal insufficiency, chronic Downcase Mesh Term urologic diseases Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term male urogenital diseases Downcase Mesh Term renal insufficiency Downcase Mesh Term chronic disease Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48191928
Agency Class OTHER
Lead Or Collaborator lead
Name Universidad del Rosario

Overall Officials

Sequence: 29206269
Role Study Chair
Name Diana Ramos-Caballero, CI
Affiliation Universidad del Rosario

Central Contacts

Sequence: 11979598
Contact Type primary
Name Gabriela García-Laguna, PI
Phone +573213781814
Email Dayan.garcia@urosario.edu.co
Role Contact

Design Group Interventions

Sequence: 67967512 Sequence: 67967513 Sequence: 67967514 Sequence: 67967515 Sequence: 67967516
Design Group Id 55443166 Design Group Id 55443168 Design Group Id 55443168 Design Group Id 55443167 Design Group Id 55443168
Intervention Id 52347074 Intervention Id 52347074 Intervention Id 52347075 Intervention Id 52347075 Intervention Id 52347076

Eligibilities

Sequence: 30685322
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria: Include participants with stage five of chronic kidney disease, People over 18 years old. Their participation is voluntary and their have signed the informed consent form. Persons that are undergoing hemodialysis for at least 3 months. Persons have ability to do exercise protocols. Persons have the approval by nephrologist doctor and deportologist for to do the study according to the results of initial medical assessment. Exclusion Criteria: Surgical intervention to least 6 months. Skeletal limitations that affect exercise performance. Psychiatric disorders and psychological such as depression, anxiety that could be affect participation of the study. Body Mass Index greater than 30 kg/m2 and not less than 18.5 kg/m2. Hemodialysis catheter dysfunction or infection as well as participation in home exercise programs.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253890452
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 14
Number Of Secondary Outcomes To Measure 1
Number Of Other Outcomes To Measure 3

Designs

Sequence: 30432043
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Masking Description The participants will be randomized; however, since it is an exercise intervention, the participants cannot be masked. When the interpretation of the data is performed, the researcher will not know what type of treatment the person being evaluated is receiving, and the researcher's advisor will make the comparison without knowing what intervention the participant was subjected to.
Intervention Model Description There will be 4 parallel groups, 3 intervention and 1 control group.
Investigator Masked True
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26599103 Sequence: 26599104 Sequence: 26599105
Intervention Id 52347074 Intervention Id 52347075 Intervention Id 52347076
Name No aplicable Name No aplicable Name No aplicable

Links

Sequence: 4375787 Sequence: 4375788 Sequence: 4375789 Sequence: 4375790
Url http://revistanefrologia.com/es-fisioterapia-durante-hemodialisis-resultados-un-programa-fuerza-resistencia-articulo-X0211699508033146 Url http://www.revistanefrologia.com/es-beneficios-del-ejercicio-fisico-baja-articulo-S0211699515000685 Url http://revistanefrologia.org/index.php/rcn/article/view/147?source=/index.php/rcn/article/view/147 Url http://revmovimientocientifico.ibero.edu.co/article/view/mct.14204
Description Fisioterapia durante la hemodiálisis: resultados de un programa de fuerza-resistencia Description Beneficios del ejercicio físico de baja intensidad durante la sesión de hemodiálisis en el paciente anciano Description Factores no tradicionales influyentes en la calidad de vida de los pacientes de hemodiálisis Description Ejercicio físico intradiálisis en pacientes con enfermedad renal crónica: características de la carga y beneficios. Una revisión de la literatura.

Responsible Parties

Sequence: 28798556
Responsible Party Type Sponsor

Study References

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Pmid 27355619 Pmid 27532211 Pmid 31865607 Pmid 30573007 Pmid 30670499 Pmid 30581137 Pmid 29608708 Pmid 29344881 Pmid 31804617 Pmid 28489182 Pmid 26316654 Pmid 30759022 Pmid 30659520 Pmid 21557787 Pmid 20392706 Pmid 24100735
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
Citation Chan D, Cheema BS. Progressive Resistance Training in End-Stage Renal Disease: Systematic Review. Am J Nephrol. 2016;44(1):32-45. doi: 10.1159/000446847. Epub 2016 Jun 30. Citation Chung YC, Yeh ML, Liu YM. Effects of intradialytic exercise on the physical function, depression and quality of life for haemodialysis patients: a systematic review and meta-analysis of randomised controlled trials. J Clin Nurs. 2017 Jul;26(13-14):1801-1813. doi: 10.1111/jocn.13514. Epub 2017 Mar 20. Citation Ferrari F, Helal L, Dipp T, Soares D, Soldatelli A, Mills AL, Paz C, Tenorio MCC, Motta MT, Barcellos FC, Stein R. Intradialytic training in patients with end-stage renal disease: a systematic review and meta-analysis of randomized clinical trials assessing the effects of five different training interventions. J Nephrol. 2020 Apr;33(2):251-266. doi: 10.1007/s40620-019-00687-y. Epub 2019 Dec 21. Citation Molsted S, Bjorkman ASD, Lundstrom LH. Effects of strength training to patients undergoing dialysis: a systematic review. Dan Med J. 2019 Jan;66(1):A5526. Citation Pu J, Jiang Z, Wu W, Li L, Zhang L, Li Y, Liu Q, Ou S. Efficacy and safety of intradialytic exercise in haemodialysis patients: a systematic review and meta-analysis. BMJ Open. 2019 Jan 21;9(1):e020633. doi: 10.1136/bmjopen-2017-020633. Citation Scapini KB, Bohlke M, Moraes OA, Rodrigues CG, Inacio JF, Sbruzzi G, Leguisamo CP, Sanches IC, Tourinho Filho H, Irigoyen MC. Combined training is the most effective training modality to improve aerobic capacity and blood pressure control in people requiring haemodialysis for end-stage renal disease: systematic review and network meta-analysis. J Physiother. 2019 Jan;65(1):4-15. doi: 10.1016/j.jphys.2018.11.008. Epub 2018 Dec 21. Citation Young HML, March DS, Graham-Brown MPM, Jones AW, Curtis F, Grantham CS, Churchward DR, Highton P, Smith AC, Singh SJ, Bridle C, Burton JO. Effects of intradialytic cycling exercise on exercise capacity, quality of life, physical function and cardiovascular measures in adult haemodialysis patients: a systematic review and meta-analysis. Nephrol Dial Transplant. 2018 Aug 1;33(8):1436-1445. doi: 10.1093/ndt/gfy045. Citation Afsar B, Siriopol D, Aslan G, Eren OC, Dagel T, Kilic U, Kanbay A, Burlacu A, Covic A, Kanbay M. The impact of exercise on physical function, cardiovascular outcomes and quality of life in chronic kidney disease patients: a systematic review. Int Urol Nephrol. 2018 May;50(5):885-904. doi: 10.1007/s11255-018-1790-4. Epub 2018 Jan 17. Citation Andrade FP, Rezende PS, Ferreira TS, Borba GC, Muller AM, Rovedder PME. Effects of intradialytic exercise on cardiopulmonary capacity in chronic kidney disease: systematic review and meta-analysis of randomized clinical trials. Sci Rep. 2019 Dec 5;9(1):18470. doi: 10.1038/s41598-019-54953-x. Citation Bohm J, Monteiro MB, Andrade FP, Veronese FV, Thome FS. Acute effects of intradialytic aerobic exercise on solute removal, blood gases and oxidative stress in patients with chronic kidney disease. J Bras Nefrol. 2017 Apr-Jun;39(2):172-180. doi: 10.5935/0101-2800.20170022. Epub 2017 Apr 27. Erratum In: J Bras Nefrol. 2017 Aug 17;:180. English, Portuguese. Citation Anding K, Bar T, Trojniak-Hennig J, Kuchinke S, Krause R, Rost JM, Halle M. A structured exercise programme during haemodialysis for patients with chronic kidney disease: clinical benefit and long-term adherence. BMJ Open. 2015 Aug 27;5(8):e008709. doi: 10.1136/bmjopen-2015-008709. Citation Clarkson MJ, Bennett PN, Fraser SF, Warmington SA. Exercise interventions for improving objective physical function in patients with end-stage kidney disease on dialysis: a systematic review and meta-analysis. Am J Physiol Renal Physiol. 2019 May 1;316(5):F856-F872. doi: 10.1152/ajprenal.00317.2018. Epub 2019 Feb 13. Citation Salhab N, Karavetian M, Kooman J, Fiaccadori E, El Khoury CF. Effects of intradialytic aerobic exercise on hemodialysis patients: a systematic review and meta-analysis. J Nephrol. 2019 Aug;32(4):549-566. doi: 10.1007/s40620-018-00565-z. Epub 2019 Jan 18. Citation Smart N, Steele M. Exercise training in haemodialysis patients: a systematic review and meta-analysis. Nephrology (Carlton). 2011 Sep;16(7):626-32. doi: 10.1111/j.1440-1797.2011.01471.x. Citation Tentori F, Elder SJ, Thumma J, Pisoni RL, Bommer J, Fissell RB, Fukuhara S, Jadoul M, Keen ML, Saran R, Ramirez SP, Robinson BM. Physical exercise among participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS): correlates and associated outcomes. Nephrol Dial Transplant. 2010 Sep;25(9):3050-62. doi: 10.1093/ndt/gfq138. Epub 2010 Apr 13. Citation Silva SF, Pereira AA, Silva WA, Simoes R, Barros Neto Jde R. Physical therapy during hemodialyse in patients with chronic kidney disease. J Bras Nefrol. 2013 Jul-Sep;35(3):170-6. doi: 10.5935/0101-2800.20130028. English, Portuguese.