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

• Register: ISRCTN
• Last refreshed on: 4 November 2019
• Main ID: ISRCTN10251828
• Date of registration: 06/12/2016
• Prospective Registration: No
• Primary sponsor: Hospital General de México, Dr Eduardo Liceaga
• Public title: Aerobic versus anaerobic exercise and oral nutritional supplementation in nutritional status and physical function of adults hemodialysis patients
• 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
• Date of first enrolment: 01/11/2016
• Target sample size: 40
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10251828
• Study type: Interventional
• Study design: Parallel single-centre randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Mexico

Contacts

• Name: Lucía Monserrat Pérez

• Name: Geovana Martin

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Hemodialysis
Urological and Genital Diseases

Intervention(s)

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 dur

Primary Outcome(s)

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 and the tip of the elbow (olecranon process and the acromium)
3.3. Mid arm muscle circumference = mid arm circumference – (p x triceps skinfold thickness)
3.4. Bone-free arms muscle area: males = [(midarm circumference (cm) - p x triceps (cm)]2/4 p) - 10; females = [(midarm circumference (cm) - p x triceps (cm)]2/4 p) - 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(s)

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

Secondary ID(s)

DI/16/105-B-04-128

Source(s) of Monetary Support

Hospital General de México, Dr Eduardo Liceaga

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 01/09/2017