Effect of nutritional supplement taken with and without exercise on muscle condition in adults on hemodialysis: A randomized controlled trial

Oral nutritional supplementation alone compared to oral nutritional supplementation with exercise on the skeletal muscle quantity and quality of adult hemodialysis patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63121006

Enrollment

Registered

2019-02-27

Start date

2019-03-01

Completion date

Unknown

Last updated

2023-04-10

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

Conditions

Adult hemodialysis patients Urological and Genital Diseases

Interventions

We are going to randomize our patients to one of the two groups using a blocked design in the Research Randomizer program (www. randomizer.org). The intervention is during the hemodialysis treatment (

afterwards, each subject will be asked to use 500 g ankle weights and TheraBand Latex Resistance Bands® will be used to individualize the exercise. Patients will perform four types of resistance exerc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hemodialysis two or three times a week 2. Age > 18 years 3. No previous exercise program participation

Exclusion criteria

Exclusion criteria: 1. Limb amputation 2. Hospitalization in the last 3 months 3. One or less hemodialysis session a week 4. Severe effort angina (CC3) or stage 4 of the New York Heart Association (NYHA) classification scale of heart failure 5. Pregnancy 6. Severe dyspnoea 7. Femoral fistula 8. Arrhythmias 9. Precordial pain 10. Orthopaedic or neurological compromises or cognitive alterations affecting study participation.

Design outcomes

Primary

Measure	Time frame
Quantity of muscle mass: 1. Indicators of muscle mass using anthropometry, measured at baseline, 3-months, and 6-months: 1.1 Mid-arm muscle circumference: mid-arm circumference – (p x triceps skinfold thickness) 1.2 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 2. Mid-thigh cross-sectional area of muscle mass measured with computed tomography. Quality of muscle mass: 3. Intramuscular lipid infiltration with computed tomography, measured at baseline and at six months. 4. Physical function tests, measured at baseline, 3-months, and 6-months: 4.1 Sit to stand test: To move from a sitting position to a standing position on a 42cm high chair as quick as possible, for ?ve times. 4.2 Time up and go test: measures the time in seconds for a patient to rise from a standard armchair, walk 3 meters, turn around, and return and sit down again. 4.3 Six-minute walk test: To walk back and forth along a 22 m course (two 10-m straight lines connected by two 1-m curves) in a corridor for 6 min. We are going to use the protocol of the American Thoracic Society. Subjects are allowed to rest in case of fatigue or pain, and to resume when possible	—

Measure

Time frame

Quantity of muscle mass: 1. Indicators of muscle mass using anthropometry, measured at baseline, 3-months, and 6-months: 1.1 Mid-arm muscle circumference: mid-arm circumference – (p x triceps skinfold thickness) 1.2 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 2. Mid-thigh cross-sectional area of muscle mass measured with computed tomography. Quality of muscle mass: 3. Intramuscular lipid infiltration with computed tomography, measured at baseline and at six months. 4. Physical function tests, measured at baseline, 3-months, and 6-months: 4.1 Sit to stand test: To move from a sitting position to a standing position on a 42cm high chair as quick as possible, for ?ve times. 4.2 Time up and go test: measures the time in seconds for a patient to rise from a standard armchair, walk 3 meters, turn around, and return and sit down again. 4.3 Six-minute walk test: To walk back and forth along a 22 m course (two 10-m straight lines connected by two 1-m curves) in a corridor for 6 min. We are going to use the protocol of the American Thoracic Society. Subjects are allowed to rest in case of fatigue or pain, and to resume when possible

—

Secondary

Measure	Time frame
1. Serum concentrations of myostatin by ELISA, measured at baseline and at six months. 2. Quality of life of patients using the SF-36 KDQOL scale, measured at baseline and at six months. 3. Biochemical indicators of nutritional status (albumin, creatinine, total lymphocyte count and cholesterol) before and after the intervention, measured at baseline and at six months. 4. Dietary indicators of nutritional status (protein and energy intake) before and after the intervention, measured at baseline and at six months. 5. Percentage of patients with protein-energy wasting before and after the intervention	—

Measure

Time frame

1. Serum concentrations of myostatin by ELISA, measured at baseline and at six months. 2. Quality of life of patients using the SF-36 KDQOL scale, measured at baseline and at six months. 3. Biochemical indicators of nutritional status (albumin, creatinine, total lymphocyte count and cholesterol) before and after the intervention, measured at baseline and at six months. 4. Dietary indicators of nutritional status (protein and energy intake) before and after the intervention, measured at baseline and at six months. 5. Percentage of patients with protein-energy wasting before and after the intervention

—

Countries

Mexico

Outcome results

None listed

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