Clinical trial NCT02379533: Effects of Home-based or Center-based Aerobic Exercise in Patients With Chronic Kidney Disease
Official title: Effects of Home-based or Center-based Aerobic Exercise on Physical Function, Nutritional Status Ans Cardiopulmonary Parameters in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Obese
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-03-05
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Cardiopulmonary capacity
timeFrame: 24 weeks
measure: Functional capacity (walk, sit-stand, arm curl, sit-reach, back scratch, timed up and go)
timeFrame: 24 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 24 weeks
measure: sleep quality (PSQI)
timeFrame: 24 weeks
measure: blood pressure
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Lilian Cuppari, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Danilo T Aoike, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.