Intradialisis Physical Exercise in Quality of Life and Health

NCT ID: NCT05207527

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2028-11-29

Brief Summary

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Evaluate the effectiveness of different modalities of physical exercise about clinical health indicators and quality of life of patients with chronic kidney disease undergoing hemodialysis.

Detailed Description

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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

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There will be 4 parallel groups, 3 intervention and 1 control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Cardiovascular exercise

Cycloergometer

Group Type EXPERIMENTAL

cardiovascular exercise

Intervention Type OTHER

Exercise that mainly stimulates the cardiovascular and respiratory systems.

Muscle strength

Strength exercises will be performed during the hemodialysis session.

Group Type EXPERIMENTAL

Muscle strength

Intervention Type OTHER

Exercise that primarily stimulates the musculoskeletal system.

Mixed

Both aerobic and muscular strength exercises will be performed.

Group Type EXPERIMENTAL

cardiovascular exercise

Intervention Type OTHER

Exercise that mainly stimulates the cardiovascular and respiratory systems.

Muscle strength

Intervention Type OTHER

Exercise that primarily stimulates the musculoskeletal system.

Mixed

Intervention Type OTHER

Exercise that stimulates the musculoskeletal, cardiovascular and respiratory systems.

Control

Conventional treatment or dyalisis usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cardiovascular exercise

Exercise that mainly stimulates the cardiovascular and respiratory systems.

Intervention Type OTHER

Muscle strength

Exercise that primarily stimulates the musculoskeletal system.

Intervention Type OTHER

Mixed

Exercise that stimulates the musculoskeletal, cardiovascular and respiratory systems.

Intervention Type OTHER

Other Intervention Names

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No aplicable No aplicable No aplicable

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad del Rosario

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diana Ramos-Caballero, CI

Role: STUDY_CHAIR

Universidad del Rosario

Central Contacts

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Gabriela García-Laguna, PI

Role: CONTACT

+573213781814

References

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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.

Reference Type BACKGROUND
PMID: 27355619 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27532211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31865607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30573007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30670499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30581137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29608708 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29344881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31804617 (View on PubMed)

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. English, Portuguese.

Reference Type BACKGROUND
PMID: 28489182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26316654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30759022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30659520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21557787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20392706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24100735 (View on PubMed)

Related Links

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http://www.revistanefrologia.com/es-beneficios-del-ejercicio-fisico-baja-articulo-S0211699515000685

Beneficios del ejercicio físico de baja intensidad durante la sesión de hemodiálisis en el paciente anciano

http://revistanefrologia.org/index.php/rcn/article/view/147?source=/index.php/rcn/article/view/147

Factores no tradicionales influyentes en la calidad de vida de los pacientes de hemodiálisis

Other Identifiers

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DVO005 769-CV1091

Identifier Type: -

Identifier Source: org_study_id

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