Exercise Intervention in Patients With Metabolic Syndrome and Renal Disease: a Prospective Study
NCT Number: NCT06576518
Acronym: EXRED
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Syndrome|CKD
Interventions: OTHER: Therapeutic exercise
Sponsor: University of La Laguna
Collaborators: Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-06-10
Completion Date: 2024-05-27
Locations: Universidad de La Laguna, San Cristobal de La laguna, Santa Cruz De Tenerife, 38320, Spain

Summary:
INTRODUCTION: Obesity (OB) and metabolic syndrome (MetS) are risk and progression factors for chronic kidney disease (CKD). However, the effect of OB/MetS intervention with exercise on renal function progression and proteinuria is unknown.

OBJECTIVE: To analyse the effect of therapeutic exercise on MetS and main renal outcomes in patients with CKD.

METHODOLOGY: This is a 6-month prospective exploratory study. Patients with stablished CKD (1-4) and MetS were treated with individualised incremental exercise (aerobic and resistance). Simultaneously, a plan of adherence was set up to promote compliance. Renal and metabolic outcomes were collected. The main renal parameters were: proteinuria, in isolated urine samples, and glomerular filtration rate (GFR), measured by iohexol DBS, at 0, 3 and 6 months. At the same time points, metabolic outcomes were measured: weight, dyslipidemia, insulin resistance and hypertension.

Primary Outcome Measures: Changes in Glomerular filtration rate (GFR) and urine abulmin-creatinine ratio (UACR)., GFR and UACR were measured at baseline, 3 and 6 months, with the gold standard method of plasma clearance of iohexol (DBS technique) and urine analysis (isolated urine samples), respectively. The researchers expect a change in terms of GFR (improvement of hyperfiltration) and UACR reduction compared to baseline., Baseline, 3 and 6 months
Secondary Outcome Measures: Changes in body weight and MetS traits (Analytics)., Monthly, weight in kilograms, height in meters, waist circumference, hip circumference, will be measured. Also, BMI Body mass index (BMI): weight in kilograms divided by the square of the height in meters.Weight changes \>5% were expected at 6 months.

Changes in Mets traits as a relative change from baseline (%) or as success in falling below the cut-off point of the MetS definition. To evaluate the improvements in metabolic risk factors profile: obesity, triglycerides, blood pressure and HDL cholesterol.hemogram (hematocrit, haemoglobin, white blood count), biochemist tests: creatinine, HbA1c, total, LDL and HDL cholesterol, triglycerides, uric acid, hepatic enzymes (ASAT, ALAT), levels of immunosuppression, albumin, creatinine, albuminuria, proteinuria in an isolated urinary samples., Baseline, month 3 and 6.|Compliance-adherence, To ensure compliance, the following measures will be implemented: (a) contact by phone one time per week, (b) individual interview every month to reinforce lifestyle changes and follow all recommended in the exercise prescription; (c) the use of a gadget (xiaomi mi band) to see daily routines of patients and every training prescription, analysing the time, frequency, burned calories, velocity and distance, among others, to reach the established goal prescribed by the physiotherapist., Monthly