Intradialisis Physical Exercise in Quality of Life and Health

Официальное название

Design and Effectiveness of Different Physical Exercise-based Interventions About Health Indicators and Quality of Life in Patients With Chronic Kidney Disease in Hemodialysis

Обзор

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.

Подробное описание

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

Вмешательства

• Другое cardiovascular exercise
  Exercise that mainly stimulates the cardiovascular and respiratory systems.
• Другое Muscle strength
  Exercise that primarily stimulates the musculoskeletal system.
• Другое Mixed
  Exercise that stimulates the musculoskeletal, cardiovascular and respiratory systems.

Первичные конечные точки

• Health indicators - Dialysis efficiency [Срок оценки: 6 months]
• Health indicators - KT/V [Срок оценки: 6 months]
• Health indicators - Sarcopenia [Срок оценки: 6 months]
• Kidney Disease and Quality of Life (KDQOL-36) [Срок оценки: 6 months]
• Physical condition - Body composition1 [Срок оценки: 6 months]
• Physical condition - Body composition2 [Срок оценки: 6 months]
• Physical condition - Body composition3 [Срок оценки: 6 months]
• Physical condition - Body composition4 [Срок оценки: 6 months]
• Physical condition - Body composition5 [Срок оценки: 6 months]
• Muscle strength [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Depression and anxiety (Beck Scale) [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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
• 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
• 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.jph PMID 30581137
• 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: 10.1 PMID 29608708
• 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

Идентификаторы

NCT: NCT05207527 · DVO005 769-CV1091

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗