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

NCT ID: NCT06576518

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2024-05-27

Brief Summary

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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

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Conditions

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Metabolic Syndrome CKD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise group

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

Group Type EXPERIMENTAL

Therapeutic exercise

Intervention Type OTHER

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

Interventions

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Therapeutic exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias

OTHER

Sponsor Role collaborator

University of La Laguna

OTHER

Sponsor Role lead

Responsible Party

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Raúl Morales Febles

PhD-Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad de La Laguna

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

Site Status

Countries

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Spain

Other Identifiers

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CHUC_2021_32

Identifier Type: -

Identifier Source: org_study_id

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