Exercise Intervention in Patients With Metabolic Syndrome and Renal Disease: a Prospective Study

Not Applicable

Completed

• Conditions: Metabolic Syndrome; CKD
• Interventions: Other: Therapeutic exercise

• Registration Number: NCT06576518
• Lead Sponsor: University of La Laguna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-10
• Primary Completion: 2021-12-02
• Study Completion: 2024-05-27
• Status Verified: 2024-08
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• age >18 years
• CKD of diverse aetiologies
• estimated GFR ≥ 30 ml/min
• BMI ≥ 27 kg/m2 associated to MetS or diabetes mellitus (DM)
• stable renal function for at least 6 months before screening
• ability to perform exercise

Exclusion Criteria

• clinical conditions that exclude exercise therapy such as clinical instability, active infection, cancer, acute cardiovascular disease, advanced CKD, pulmonary hypertension, or limb amputations
• inability to understand the protocol
• severe psychiatric illness
• allergy to iodine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise group	Therapeutic exercise	Patients with established CKD (1-4) and MS were treated with individualised incremental exercise (aerobic and resistance) for 6 months.

Primary Outcome Measures

Name	Time	Method
Changes in Glomerular filtration rate (GFR) and urine abulmin-creatinine ratio (UACR).	Baseline, 3 and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Changes in body weight and MetS traits (Analytics).	Baseline, month 3 and 6.	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.
Compliance-adherence	Monthly	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.

Trial Locations

Locations (1)

Universidad de La Laguna; 🇪🇸 San Cristobal de La laguna, Santa Cruz De Tenerife, Spain