Condition category
Urological and Genital Diseases
Date applied
11/11/2016
Date assigned
06/12/2016
Last edited
06/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hemodialysis is a process of purifying the blood of a person whose kidneys are not working normally. A condition called protein-energy wasting, where the body has decreased stores of protein and fat, is common in patients undergoing hemodialysis. Studies have looked at the benefits of oral nutritional supplements, resistance exercise (e.g., weight training) and aerobic exercise (e.g., cycling) on nutrition and physical function, but it is not known what kind of treatment is best for patients. The aim of this study is to compare the effect of oral nutritional supplementation plus resistance exercise, oral nutritional supplementation plus aerobic exercise, and oral nutritional supplementation alone.

Who can participate?
Patients aged 18 to 45 undergoing hemodialysis

What does the study involve?
Participants are randomly allocated to receive one of three treatments two times per week for 12 weeks: either oral nutritional supplement plus resistance exercise, oral nutritional supplement plus aerobic exercise, or oral nutritional supplement alone. At the end of the study participants’ body measurements, blood test results, physical function and quality of life are assessed.

What are the possible benefits and risks of participating?
It has been shown that exercise and oral nutritional supplements are safe and beneficial. Low blood pressure and symptoms such as diarrhoea and nausea have been associated with oral nutritional supplements, but there is a lack of evidence supporting this.

Where is the study run from?
Hospital General de México, Dr Eduardo Liceaga (Mexico)

When is the study starting and how long is it expected to run for?
January 2016 to September 2017

Who is funding the study?
Hospital General de México, Dr Eduardo Liceaga (Mexico)

Who is the main contact?
1. Dr Lucía Monserrat Pérez
2. Miss Geovana Martin

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lucía Monserrat Pérez

ORCID ID

http://orcid.org/0000-0002-9281-9202

Contact details

Dr. Balmis 148
Cuauhtémoc
Doctores
México City
06726
Mexico

Type

Public

Additional contact

Miss Geovana Martin

ORCID ID

http://orcid.org/0000-0003-3583-6126

Contact details

Dr. Balmis 148
Cuauhtémoc
Doctores
México City
06726
Mexico

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DI/16/105-B-04-128

Study information

Scientific title

A prospective randomized trial, Aerobic Versus ANaerobic exercise and oral nuTritional supplEmentation in nutritional status and physical function of adults HEMOdialysis Patients: the AVANTE-HEMO study

Acronym

AVANTE-HEMO

Study hypothesis

Hemodialysis (HD) patients who perform resistance exercise (RE) + receive oral nutritional supplementation (ONS) will have better parameters of nutritional status and physical function than patients of the aerobic plus oral nutritional supplementation group and oral nutritional supplementation group.

Ethics approval

Hospital General de México, Dr. Eduardo Liceaga ethics committee, 28/09/2016, ref: DI/16/105-B-04-128

Study design

Parallel single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Hemodialysis

Intervention

Method of randomization: A blocked design will be used, using an online statistical computing web programming (www.randomizer.org) to generate the randomization schedule, 14 sets of 3 unique numbers per set range from 1 to 3 (representing the three treatment arms).

Control arm
During the HD sessions, patients receive a can of a specialized oral nutritional supplement for maintenance dialysis patients that consists of 480 kcal, 20 g protein and 20 g lipids (Enterex RNL, Pisa Laboratories). Enterex RNL contains omega-3 and omega-6 fatty acids, maltodextrin and sucralose.

Aerobic exercise arm
Patients of this group receive the same specialized oral nutritional supplement during the HD session, half of the a can is administered during the first hour of the HD session and the other half after the AE routine. Aerobic exercise consists of pedaling a stationary bike for the first two hours of the HD session, the optimal exercise time is established during the first session, then is gradually increased to reach 20-30 minutes. The scale of perceived exertion Borg (6-20) is used to establish the intensity of the exercise (moderate intensity, 12-13).

Resistance exercise arm
Patients of this group receive the same specialized oral nutritional supplement during the HD session, half of the a can is administered during the first hour of the HD session and the other half after the RE routine. Patients are trained for three months according to an adaptation to the program “Exercise: A Guide for People on Dialysis”. Four types of resistance exercise are performed during the second hour of the HD session (four sets of 20 repetitions for 40 min). TheraBand Latex Resistance Bands are used to individualize the exercise. The scale of perceived exertion Borg (6-20) is used to establish the intensity of the exercise (moderate intensity, 12-13)

Frequency and duration of treatment: Two times per week for 12 weeks (40 minutes of resistance exercise and 30 minutes of aerobic exercise)
Follow-up: 12 weeks

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Measured at baseline and 3 months:
1. Weight: The weight reached by the patient at the end of a session which has removed the maximum fluid without inducing hypotension (seca 676 wheelchair scale, wireless)
2. Body mass index: body mass divided by the square of the body height
3. Anthropometric measurements: skinfold thickness (biceps, triceps, subescapular, supra-iliac) using a Lange skin fold caliper to estimate:
3.1. Fat mass percentage: calculated using Siri´s (1956) equation = (4.95/density)-4.50*100
3.2. Mid-upper arm circumference: measured at the mid-point between the tip of the shoulder ant the tip of the elbow (olecranon process and the acromium)
3.3. Mid arm muscle circumference = mid arm circumference – (π x triceps skinfold thickness)
3.4. Bone-free arms muscle area: males = [(midarm circumference (cm) - π x triceps (cm)]2/4 π) - 10; females = [(midarm circumference (cm) - π x triceps (cm)]2/4 π) - 6.5
4. Handgrip strength, measured using hand dynamometry (Smedley III, Takei Scientific Instruments, Niigata City, Japan)
5. Serum albumin, measured using the bromocresol purple albumin assay
6. Physical function, measured using the six-minute walk test according to the American Thoracic Society Guidelines, Time Up and Go Test (Podsiadlo, D et al. J Am Geriatr Soc, 1191;39:142-148), five times sit to stand test
7. Bioelectrical impedance analysis (resistance, reactance and phase angle), measured using conventional impedance (single frequency; Quantum System, RJL Systems, Clinton Township, MI, USA)

Secondary outcome measures

Measured at baseline and 3 months:
1. Quality of life, measured using the Kidney Disease Quality of Life Short Form (KDQOF-SF)
2. C Reactive Protein, measured using the nephelometric assay

Overall trial start date

01/01/2016

Overall trial end date

01/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Regular HD two or more times a week
2. Signed informed consent
3. Any gender
4. Age >18 to <45 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Patients with an amputation
2. Hospitalization in the last 3 months
3. Unsatisfactory attendance at HD sessions
4. Pregnancy
5. Excessive pallor
6. Severe dyspnea
7. Femoral fistula
8. Arrhythmias
9. Precordial pain
10. Orthopedic or neurological compromises or cognitive alterations affecting their participation in the study

Recruitment start date

01/11/2016

Recruitment end date

31/01/2017

Locations

Countries of recruitment

Mexico

Trial participating centre

Hospital General de México, Dr Eduardo Liceaga
Dr. Balmis 148 Cuauhtémoc Doctores
Ciudad de México, D.F.
06726
Mexico

Sponsor information

Organisation

Hospital General de México, Dr Eduardo Liceaga

Sponsor details

Dr. Balmis 148
Cuauhtémoc
Doctores
México City
06726
Mexico

Sponsor type

Hospital/treatment centre

Website

http://www.hgm.salud.gob.mx/

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital General de México, Dr Eduardo Liceaga

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

01/09/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes