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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10251828

Enrollment

Registered

2016-12-06

Start date

2016-11-01

Completion date

Unknown

Last updated

2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Urological and Genital Diseases

Interventions

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 p

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Mexico

Contacts

Public ContactGeovana Martin

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026