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

Category Primary study
Registry of TrialsISRCTN registry
Year 2016
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) Fol CONDITION: Hemodialysis ; Urological and Genital Diseases SECONDARY OUTCOME: 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 INCLUSION CRITERIA: 1. Regular HD two or more times a week 2. Signed informed consent 3. Any gender 4. Age >18 to <45 years PRIMARY OUTCOME: 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)
Epistemonikos ID: 82fe3b82bab3c0e19cb3878f2fff60418d5c2e5f
First added on: Aug 24, 2024