Effects of Home-based or Center-based Aerobic Exercise in Patients With Chronic Kidney Disease

NCT ID: NCT02379533

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-03-31

Brief Summary

Patients will be randomly assigned to perform the training program in center or home-based . The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine. All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes). The program will consist of 24 weeks with three sessions per week on alternate days. The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks. The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways. The intensity control was done by means of the heart rate value obtained at ventilatory threshold.

Both groups receive the same intervention. However, a group exercise held in the center on a treadmill with the direct supervision of a physical education teacher. The other group will exercise at home with telephone follow-up weekly and once a month will be held at the training center under the supervision of a physical education teacher.

It will also constituted a control group remain without performing any activity during the study period. After 24 weeks patients receive the same advice the team conducting the training at home.

Conditions

Chronic Renal Failure; Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

sedentary control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Home-based aerobic exercise

The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine. All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes). The program will consist of 24 weeks with three sessions per week on alternate days. The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks. The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways. The intensity control was done by means of the heart rate value obtained at ventilatory threshold. The home-based exercise group exercise at home with telephone follow-up weekly and once a month will be held at the training center under the supervision of a physical education teacher.

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: OTHER

Center-based aerobic exercise

The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine. All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes). The program will consist of 24 weeks with three sessions per week on alternate days. The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks. The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways. The intensity control was done by means of the heart rate value obtained at ventilatory threshold. However, a group exercise held in the center on a treadmill with the direct supervision of a physical education teacher.

Group Type: ACTIVE_COMPARATOR

Aerobic exercise

Intervention Type: OTHER

Interventions

Aerobic exercise

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Sedentary individuals with chronic kidney disease stages 3 or 4 disease;
• Both genders;
• Age between 30 and 65 years;
• Overweight (BMI> 25 kg/m2);
• With a negative stress test.

Exclusion Criteria

• Patients with chronic obstructive pulmonary disease,
• class IV heart failure,
• myocardial infarction within the last 6 months,
• decompensated hypertension (systolic blood pressure> 180 mmHg or diastolic> 110 mmHg in the last 6 months),
• uncontrolled cardiac arrhythmia,
• decompensated diabetes mellitus (glycated hemoglobin> 8.0%),
• unstable angina,
• infectious processes in the last 3 weeks;
• begin use of erythropoietin or with hemoglobin <11g/L.
• use of beta-blocker medication

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Lilian Cuppari

PhD, Affiliate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lilian Cuppari, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Danilo T Aoike, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

References

Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.

Reference Type: DERIVED

PMID: 33782940 (View on PubMed)

Gomes TS, Aoike DT, Baria F, Graciolli FG, Moyses RMA, Cuppari L. Effect of Aerobic Exercise on Markers of Bone Metabolism of Overweight and Obese Patients With Chronic Kidney Disease. J Ren Nutr. 2017 Sep;27(5):364-371. doi: 10.1053/j.jrn.2017.04.009. Epub 2017 Jun 9.

Reference Type: DERIVED

PMID: 28606422 (View on PubMed)

Other Identifiers

2009/14786-0

Identifier Type: -

Identifier Source: org_study_id