Quality of Life, Nutritional Status and Functional Capacity in People With Advanced Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Other: Specific dietary treatment and follow-up using coaching techniques

• Registration Number: NCT05072574
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary

This study evaluates the clinical response (quality of life, nutritional status, functional capacity, and disease knowledge) of advanced CKD patients who undergo an individualized dietary intervention and a nutritional education program (group workshops) using motivation coaching techniques, compared to controls who receive general hygiene-nutritional education at every visit.

Detailed Description

Randomized study including two parallel groups: patients from the advanced chronic kidney disease (CKD) consulting room of the Malaga University Regional Hospital and controls. The main objective is to assess the clinical response (quality of life, nutritional status, functional capacity, and disease knowledge) of advanced CKD patients who undergo an individualized dietary intervention and a nutritional education program (group workshops) using motivation coaching techniques, compared to controls who receive general hygiene-nutritional education at every visit.

Both groups will be composed of 54 participants. The control group will be provided general dietary and lifestyle recommendations (standard procedure in the nephrology consulting room), whereas the intervention group will receive treatment and individualized dietary follow-up using coaching techniques, supported by information and communication technologies, and will participate in a nutritional education program composed of four on-line sessions.

Two visits (basal and three months after) will be scheduled during the study to obtain and analyse the data. Moreover, in these visits researchers will collect a blood sample in order to perform an assessment of the metabolism, inflammation, and oxidation, and a stool sample in order to evaluate the gut microbiota.

Study Timeline

• Study First Submitted: 2021-04-08
• Study Start: 2021-04-23
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-11
• Status Verified: 2022-02
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients >18 years old with advanced CKD (GFR <30ml/min) starting follow-up in the advanced CKD consulting room of the Malaga University Regional Hospital and who clearly understand the study and give their informed consent.

Exclusion Criteria

• Patients presenting any of these conditions:

  • Active cancer
  • Being already participants of another study that may affect the results
  • Pregnancy or possible pregnancy
  • Informed consent refusal
  • Hospital admission during one month previous to the study
  • Severe mental disorders (SMD), prolonged mental disorders involving a high level of disability and social dysfunction, which requires attendance by the mental health and social care network
  • Alcohol or any other substance abuse that, in the researcher's opinion, may interfere with the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: nutritional education program	Specific dietary treatment and follow-up using coaching techniques	Specific dietary treatment and follow-up using coaching techniques, supported by new technologies, and will attend a nutritional education program

Primary Outcome Measures

Name	Time	Method
Assess the clinical response after the quality of life intervention	From baseline to week 12	Kidney Disease and Quality of Life test (KDQOL-36). The generic component of the KDQOL-36 (items 1-12) is the SF-12, which allows obtaining 2 general scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The specific component of the KDQOL-36 (items 13-36), allows obtaining the scores of the specific subscales for the disease.

Secondary Outcome Measures

Name	Time	Method
Change in LDL concentration	From baseline to week 12	Serum LDL in mg/dl
Assess the clinical response after intervention in the management of CKD	From baseline to week 12	Self-Efficacy for Managing Chronic Disease test. The Self-Efficacy Scale for the Management of Chronic Diseases (SEMCD) is made up of 6 items on an analog scale, ranging from 1 (not at all sure) to 10 (totally safe).; The Spanish version (SEMCD-S) consists of 4 items. A higher number means greater self-efficacy. The scale score is the mean of the items.
Assess the clinical response after the intervention in knowledge about the disease	From baseline to week 12	Kidney Disease Knowledge Survey test. The Kidney Disease Knowledge Survey (KiKS) instrument consists of 28 items and aims to assess specific knowledge about chronic kidney disease in non-dialysis patients. One point is considered for each correct answer and zero for the incorrect one. The total score is calculated by adding all the correct points and divided by 28, obtaining a value from 0 to 1, with 1 being the highest level of knowledge.
Change in weight	From baseline to week 12	Weight in kg
Change in fat free body mass	From baseline to week 12	Fat free body mass in kg assessed by bioelectrical impedance analysis
waist circumference	From baseline to week 12	circumference in cm
Change in serum albumin concentration	From baseline to week 12	Serum albumin in g/dl
Change in serum prealbumin concentration	From baseline to week 12	Serum prealbumin in mg/dl
Change in HDL concentration	From baseline to week 12	Serum HDL in mg/dl
BMI (body mass index) changes	From baseline to week 12	Measured by body composition analysis
Change in serum potassium concentration (assess kidney function)	From baseline to week 12	serum potassium in mEq/l
Change in iron concentration	From baseline to week 12	Serum iron in μg/dl
Change in intact parathyroid hormone (PTHi) concentration	From baseline to week 12	Serum intact parathyroid hormone (PTHi) in pg/ml
Change in upper arm circumference	From baseline to week 12	circumference in cm
Change in arm muscle circumference	From baseline to week 12	circumference in cm
Change in serum phosphorus concentration (assess kidney function)	From baseline to week 12	serum phosphorus mg/dl
Change in glomerular filtration (assess kidney function)	From baseline to week 12	Calculated with the formula of CKD-EPI and MDRD and measured in ml/ min/ 1.73 m2
Change in cholesterol concentration	From baseline to week 12	Serum cholesterol in mg/dl
Change in TG concentration	From baseline to week 12	Serum TG in mg/dl
Change in ferritin concentration	From baseline to week 12	Serum ferritin in ng/ml
Change in calcium concentration	From baseline to week 12	Serum calcium in mg/dl
Changes in vitamin D	From baseline to week 12	Serum vitamin D in ng/ml
Changes the clinical response after the intervention in blood pressure figures (mmHg).	From baseline to week 12	Assess if syastolic and diastolic pressure improves after training and at 6 months of follow-up.
Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)	From baseline to week 12	Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl
Changes in blood cells	From baseline to week 12	Blood count
Change in uric acid concentration	From baseline to week 12	Serum uric acid in mg/dl
Change in urea concentration	From baseline to week 12	Serum uric acid in mg/dl
Change in magnesium concentration	From baseline to week 12	Serum magnesium in mg/dl
Assess changes in the degree of depression and / or anxiety	From baseline to week 12	HADS depression and anxiety symptoms screening test. It is a self-administered scale with 14 items divided into 2 subscales (anxiety and depression) whose maximum score is 21 points for each of them. Based on the score obtained, the patients can be classified as normal (\<7), doubtful (between 8 and 10) and potential clinical case (≥ 11). The score is referred to the last week.
Change from Handgrip Strength	From baseline to week 12	Strength will be recorded by Jamar Hydraulic Hand Dynamometer (Kg)
Changes in metabolic control	From baseline to week 12	Measured as HbA1c (glycated hemoglobin)
Characterize exercise participant behavior	From baseline to week 12	International Physical Activity Questionnaire (IPAQ). The IPAQ consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) carried out in the last seven days, as well as walking and sitting time in a work day. It evaluates three characteristics of physics (PA): intensity (mild, moderate or vigorous), frequency (days per week) and duration (time per day). Weekly activity is recorded in Mets (Metabolic Equivalent of Task or Metabolic Index Units) per minute and week.
Diet composition: PREDIMED test (Prevention with Mediterranean Diet)	From baseline to week 12	Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence)
Assess the clinical response after the intervention on functional capacity	From baseline to week 12	Scale of autonomy for activities of daily life "Barthel test". This test measures the capacity of the person to carry out ten basic activities of daily life, obtaining a quantitative estimate of the degree of dependence of the subject. The range of possible IB values is between 0 and 100, with 5-point intervals for the original version. The closer a subject's score is to 0, the more dependency they have; the closer to 100 the more independence.
Assess on functional capacity	From baseline to week 12	Physical activity test "Short Physical Performance Battery" SPPB. This in turn includes 3 tests: balance, gait speed and getting up and sitting in a chair 5 times. Each test is scored from 0 (worst performance) to 4 (best performance): for the balance test according to a hierarchical combination of performance in the 3 component subtests and for the other 2 tests a score of 0 is assigned to those who do not complete or they attempt the task and scores from 1 to 4 based on the time spent. In addition, a total score for the entire battery is obtained, which is the sum of the 3 tests and ranges from 0 to 12.
Changes on functional capacity: International Physical Activity Questionnaire (IPAQ)	From baseline to week 12	The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. The survey consists of 27 questions and 5 parts.
Change in handgrip strength	From baseline to week 12	Handgrip strength in kg, measured by the jamar hydraulic hand dynamometer.

Trial Locations

Locations (1)

Hospital Regional Universitario de Málaga; 🇪🇸 Málaga, Spain