Influence of Exercise in Patients With Chronic Kidney Disease During Hemodialysis

NCT03556540 | Completed DMC

• 1 other identifier: 2.075.500
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Chronic Renal Failure affects a large part of the world population, being characterized by irreversible renal tissue damage, resulting in systemic disturbances that negatively affect the patient's life. The most commonly used treatment is hemodialysis, which also has certain deleterious effects, so it is necessary to look for therapies that minimize these complications. Objective: To analyze the influence of physical exercise during hemodialysis on the autonomic heart rate modulation, quality of life and physical functional ability in individuals with Chronic Renal Failure at Hospital das Clínicas Gaspar Vianna. Method: The intervention consists on performing aerobic exercise during hemodialysis. For the evaluation will be applied the KDQOL-SF ™ 1.3 questionnaire, for quality of life; 6-Minute Walk Test for physical functional ability; and cardiofrequencimeter for the autonomic heart rate modulation. Data will be stored in Microsoft Excel® spreadsheets, it will also be used for making graphs and tables. Statistical analysis will be performed in the Bioestat 5.3® program and the choice of tests will depend on the distribution and homogeneity of the data.

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease; Hemodialysis; Exercise

Outcome Measures

Primary Outcomes (3)

• Cardiac autonomic modulation by heart rate variability

  Cardiac Autonomic modulation was avaliated by Heart rate variability with Polar RS800CX

  Change from baseline heart rate variability at 3 months

• Quality of life by Kidney Disease and Quality of Life Short Form 1.3 scale

  Avaliable by Kidney Disease and Quality of Life Short Form 1.3 scale, this scale was divided in 4 domains: Your Health, Kidney Disease, Effects of kidney disease on your daily life and Satisfaction with treatment, each item is put on 0 (worst) to 100 range (better)

  Change from baseline quality of life at 3 months

• Functional capacity by 6-minute walk test

  avaliable by 6-minute walk test

  Change from baseline 6-minute walk test at 3 months

Study Arms (2)

Control

PLACEBO COMPARATOR

The volunteers without performing exercise during hemodialysis. Autonomic heart rate modulation, quality of life, physical fitness and safety level of exercise will be evaluated.

Other: physical exercise

Experimental

EXPERIMENTAL

The volunteers will perform physical exercise during hemodialysis. Autonomic heart rate modulation, quality of life, physical fitness and safety level of exercise will be evaluated.

Other: physical exercise

Interventions

physical exercise OTHER

Each participant will perform 30 minutes of aerobic physical activity, using cycle ergometer. The exercise will begin 30 minutes after the start of hemodialysis.

Control; Experimental

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Will be included in the research patients with chronic kidney disease, aged 40 to 70 years, undergoing hemodialysis

You may not qualify if:

• Will be excluded from the research, individuals who are hospitalized or that during the application of the protocol are hospitalized, have osteomioarticular diseases that prevent the proposed exercise, patients who use drugs that influence the heart rhythm , Patients with values of less than 24 points in the evaluation of the mini state of mental assessment, patients with a pacemaker installed, patients who underwent previous cardiac surgery less than six months, patients with a body mass index greater than 30 / kg / m2 .

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead
• Universidade do Estado do Pará: collaborator

Study Sites (1)

Hospital de Clínicas Gaspar Viana

Belém, Pará, 66087-660, Brazil

Location

Related Publications (4)

• Liu YM, Chung YC, Chang JS, Yeh ML. Effects of aerobic exercise during hemodialysis on physical functional performance and depression. Biol Res Nurs. 2015 Mar;17(2):214-21. doi: 10.1177/1099800414539548. Epub 2014 Jul 15.

  PMID: 25027035 RESULT

• National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015.

  PMID: 26498416 RESULT

• Martin-Alemany G, Valdez-Ortiz R, Olvera-Soto G, Gomez-Guerrero I, Aguire-Esquivel G, Cantu-Quintanilla G, Lopez-Alvarenga JC, Miranda-Alatriste P, Espinosa-Cuevas A. The effects of resistance exercise and oral nutritional supplementation during hemodialysis on indicators of nutritional status and quality of life. Nephrol Dial Transplant. 2016 Oct;31(10):1712-20. doi: 10.1093/ndt/gfw297. Epub 2016 Aug 10.

  PMID: 27510532 RESULT

• Painter P, Carlson L, Carey S, Paul SM, Myll J. Physical functioning and health-related quality-of-life changes with exercise training in hemodialysis patients. Am J Kidney Dis. 2000 Mar;35(3):482-92. doi: 10.1016/s0272-6386(00)70202-2.

  PMID: 10692275 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity

Interventions

Exercise

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; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rodrigo S Rocha, Doctor

  C

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Volunteers will not know that there are two groups. Evaluators will not know which groups the volunteers belong to when evaluating the variables.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Model Details: Each participant will perform 30 minutes of aerobic on cycle ergometer. The exercise will begin 30 minutes after the start of hemodialysis performed three times a week for three months. The sessions will be divided into heating, conditioning and cooling. In the warm-up phase 5 minutes of exercise will be performed between 60-70% of maximal heart rate, with Borg between 1 and 2. In the conditioning phase, 20 minutes of moderate exercise will be performed, with HR between 70-80% And Borg (modified) between 3 and 4. And the quench phase will be 5 min, with FC between 60-70% of the maximum and Borg (modified) between 1 and 2. Exercise will be discontinued if the participant has a systolic pressure above 180mmHg, a diastolic pressure above 95mmHg, a 20% change in heart rate, a saturation of less than 88%, physical exhaustion, chest pain, dyspnoea, dizziness and fatigue of the exercised limbs .

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: June 14, 2018
• Study Start: June 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: January 31, 2019
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)