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

NCT06576518 | Completed

• 1 other identifier: CHUC_2021_32
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; CKD

Keywords

Adherence; Chronic Kidney Disease; Metabolic Syndrome; Obesity; Therapeutic Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in body weight and MetS traits (Analytics).

  Baseline, month 3 and 6.

• Compliance-adherence

  Monthly

Study Arms (1)

Exercise group

EXPERIMENTAL

Patients with established CKD (1-4) and MS were treated with individualised incremental exercise (aerobic and resistance) for 6 months.

Other: Therapeutic exercise

Interventions

Therapeutic exercise OTHER

An individualised incremental exercise programme was simultaneously supported by an adherence plan to assess and promote compliance.

Exercise group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of La Laguna: lead
• Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias: collaborator

Study Sites (1)

Universidad de La Laguna

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Related Publications (1)

• Rivero Martin O, Morales Febles R, Delgado Mallen PI, Reseghetti E, Miquel Rodriguez RM, Estupinan Torres S, Cobo Caso MA, Cruz C, Diaz Martin L, Gonzalez Martin AR, Sanchez Baez DJ, Hernandez Marrero DJ, Luis Lima S, Porrini E. Exercise Intervention in Patients with Metabolic Syndrome and Renal Disease: A Prospective Study (EXRED). Nephron. 2025 Nov 27:1-15. doi: 10.1159/000549072. Online ahead of print.

  PMID: 41308049 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Renal Insufficiency, Chronic; Obesity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; 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; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-Physiotherapist

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 28, 2024
• Study Start: June 10, 2021
• Primary Completion: December 2, 2021
• Study Completion: May 27, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

ES (1)