Aerobic versus anaerobic exercise and oral nutritional supplementation in nutritional status and physical function of adults hemodialysis patients

ISRCTN ISRCTN10251828
DOI https://doi.org/10.1186/ISRCTN10251828
Secondary identifying numbers DI/16/105-B-04-128
Submission date
11/11/2016
Registration date
06/12/2016
Last edited
15/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Lucía Monserrat Pérez
Scientific

Dr. Balmis 148
Cuauhtémoc
Doctores
México City
06726
Mexico

ORCiD logoORCID ID 0000-0002-9281-9202
Miss Geovana Martin
Public

Dr. Balmis 148
Cuauhtémoc
Doctores
México City
06726
Mexico

ORCiD logoORCID ID 0000-0003-3583-6126

Study information

Study designParallel single-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA 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
Study acronymAVANTE-HEMO
Study objectivesHemodialysis (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(s)Hospital General de México, Dr. Eduardo Liceaga ethics committee, 28/09/2016, ref: DI/16/105-B-04-128
Health condition(s) or problem(s) studiedHemodialysis
InterventionMethod 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 typeMixed
Primary outcome measureMeasured 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 and 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 measuresMeasured 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 study start date01/01/2016
Completion date01/09/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Total final enrolment45
Key inclusion criteria1. Regular HD two or more times a week
2. Signed informed consent
3. Any gender
4. Age >18 to <45 years
Key exclusion criteria1. 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
Date of first enrolment01/11/2016
Date of final enrolment31/01/2017

Locations

Countries of recruitment

  • Mexico

Study participating centre

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

Sponsor information

Hospital General de México, Dr Eduardo Liceaga
Hospital/treatment centre

Dr. Balmis 148
Cuauhtémoc
Doctores
México City
06726
Mexico

Website http://www.hgm.salud.gob.mx/
ROR logo "ROR" https://ror.org/01php1d31

Funders

Funder type

Hospital/treatment centre

Hospital General de México, Dr Eduardo Liceaga

No information available

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact journal, such as Journal of Renal Nutrition or Nutrients in 2019.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Geovana Martin Alemañy. The trialists can share data (variables) represented in the subsequent results publication and if someone needs information for a systematic review with meta-analysis, the data will be available before the publication of the original article. The trialists are going to share anonymous information and the datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 16/10/2018 12/12/2018 No No
Results article results 01/03/2020 15/10/2019 Yes No

Additional files

ISRCTN10251828_BasicResults_16Oct18.pdf
Uploaded 12/12/2018

Editorial Notes

15/10/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
12/12/2018: Publication and dissemination plan and IPD sharing statement added. The basic results of this trial have been uploaded as an additional file.
16/10/2018: Internal review.