Intradialisis Physical Exercise in Quality of Life and Health

NCT05207527 | Not Yet Recruiting

• 1 other identifier: DVO005 769-CV1091
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Kidney Diseases

Keywords

Chronic kidney disease; Health indicators; Quality of life; Hemodialysis; Peritoneal dialysis; Cardiovascular exercise; Resistance exercise

Outcome Measures

Primary Outcomes (14)

• Health indicators - Dialysis efficiency

  Dialysis efficiency will be measured by analysis through biochemical methods in blood serum (KT/V).

  6 months

• Health indicators - KT/V

  It is an indicator of the rate of clearance of urea and other wastes by the dialyzer.

  6 months

• Health indicators - Sarcopenia

  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

  6 months

• Kidney Disease and Quality of Life (KDQOL-36)

  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

  6 months

• Physical condition - Body composition1

  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.

  6 months

• Physical condition - Body composition2

  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.

  6 months

• Physical condition - Body composition3

  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.

  6 months

• Physical condition - Body composition4

  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.

  6 months

• Physical condition - Body composition5

  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.

  6 months

• Muscle strength

  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

  6 months

• Fatigue

  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.

  6 months

• Functional capacity - SPPB

  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.

  6 months

• Functional capacity -6MWT

  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.

  6 months

• Functional capacity - 2MT

  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.

  6 months

Secondary Outcomes (1)

• Depression and anxiety (Beck Scale)

  6 months

Other Outcomes (3)

• Caloric intake

  6 months

• Number of participants that Smoke

  6 months

• Prevalence of hemodialysis

  6 months

Study Arms (4)

Cardiovascular exercise

EXPERIMENTAL

Cycloergometer

Other: cardiovascular exercise

Muscle strength

EXPERIMENTAL

Strength exercises will be performed during the hemodialysis session.

Other: Muscle strength

Mixed

EXPERIMENTAL

Both aerobic and muscular strength exercises will be performed.

Other: cardiovascular exercise; Other: Muscle strength; Other: Mixed

Control

NO INTERVENTION

Conventional treatment or dyalisis usual care

Interventions

cardiovascular exercise OTHER

Exercise that mainly stimulates the cardiovascular and respiratory systems.

Also known as: No aplicable

Cardiovascular exercise; Mixed

Muscle strength OTHER

Exercise that primarily stimulates the musculoskeletal system.

Also known as: No aplicable

Mixed; Muscle strength

Mixed OTHER

Exercise that stimulates the musculoskeletal, cardiovascular and respiratory systems.

Also known as: No aplicable

Mixed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad del Rosario: lead

Related Publications (16)

• 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.

  PMID: 27355619 BACKGROUND

• 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.

  PMID: 27532211 BACKGROUND

• 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.

  PMID: 31865607 BACKGROUND

• 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.

  PMID: 30573007 BACKGROUND

• 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.

  PMID: 30670499 BACKGROUND

• 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.

  PMID: 30581137 BACKGROUND

• 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.

  PMID: 29608708 BACKGROUND

• 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.

  PMID: 29344881 BACKGROUND

• 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.

  PMID: 31804617 BACKGROUND

• 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.

  PMID: 28489182 BACKGROUND

• 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.

  PMID: 26316654 BACKGROUND

• 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.

  PMID: 30759022 BACKGROUND

• 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.

  PMID: 30659520 BACKGROUND

• 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.

  PMID: 21557787 BACKGROUND

• 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.

  PMID: 20392706 BACKGROUND

• 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.

  PMID: 24100735 BACKGROUND

Related Links

• Fisioterapia durante la hemodiálisis: resultados de un programa de fuerza-resistencia
• Beneficios del ejercicio físico de baja intensidad durante la sesión de hemodiálisis en el paciente anciano
• Factores no tradicionales influyentes en la calidad de vida de los pacientes de hemodiálisis

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Muscle Strength

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Diana Ramos-Caballero, CI

  Universidad del Rosario

  STUDY CHAIR

Central Study Contacts

Gabriela García-Laguna, PI

CONTACT

+573213781814; Dayan.garcia@urosario.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be 4 parallel groups, 3 intervention and 1 control group.

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: January 26, 2022
• Study Start: February 15, 2025
• Primary Completion (Estimated): October 12, 2028
• Study Completion (Estimated): November 29, 2028
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share