Effects of physical exercise and vitamin D supplementation on muscle mass of hemodialysis patients

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-8ykyws
• Date of registration: 25/06/2015
• Prospective Registration: No
• Primary sponsor: Faculdade de Medicina de Botucatu
• Public title: Effects of physical exercise and vitamin D supplementation on muscle mass of hemodialysis patients
• Scientific title: Effects of physical training and vitamin D supplementation on muscle mass of hemodialysis patients
• Date of first enrolment: 30/11/2013
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-8ykyws
• Study type: Intervention
• Study design: Prevention, factorial, randomized, controlled, double-blind, 4 arms clinical trial.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Barbara Perez Vogt
• Affiliation: Faculdade de Medicina de Botucatu

• Name: Jacqueline Teixeira Caramori
• Affiliation: Faculdade de Medicina de Botucatu

Key inclusion & exclusion criteria

Inclusion criteria: Individuals older than 18 years; with chronic kidney disease on dialysis for a period greater than or equal to three months; classified as sedentary or irregularly active according to the International Physical Activity Questionnaire (IPAQ); do not have contraindications to physical activity; and accept and sign the Informed Consent.
Exclusion criteria: Individuals unable to understand the procedures performed; prior diagnosis of coronary artery disease; positive exercise test for cardiac ischemia; patients classified as active or very active based on the International Physical Activity Questionnaire; Patients who have suffered stroke; patients with cancer, liver failure, chronic infection or acute in activity; uncontrolled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic); Use of medications that affect body composition, such as corticosteroids and antiretroviral therapy.

Age minimum: 18Y
Age maximum:
Gender: -

Health Condition(s) or Problem(s) studied

Chronic kidney disease, hemodialysis

E02.870.300

C12.777.419.780.750.500

Intervention(s)

D04.808.247.222.159

Other

Group 1: 7 patients on maintenance hemodialysis that will receive Cholecalciferol (vitamin D) suplementation, dose of 50000 UI, once a week for 4 months, capsule orally,and aerobic exercise training on exercise bike (30 minutes three times a week for 4 months);
Group 2: 7 patients on maintenance hemodialysis that will receive orally a capsule of placebo once a week for 4 months, and aerobic exercise training on exercise bike (30 minutes three times a week for 4 months)and aerobic exercise training on exercise bike (30 minutes three times a week for 4 months);
Group 3: 7 patients on maintenance hemodialysis that will receive Cholecalciferol (vitamin D) suplementation, dose of 50000 UI, once a week for 4 months, capsule orally,and will not realize aerobic exercise training;
Group 4: 7 patients on maintenance hemodialysis that will receive orally a capsule of placebo once a week for 4 months, and will not realize aerobic exercise training.

I02.233.543

Primary Outcome(s)

Significant increase in total muscle mass in the assessment before and after intervention period assessed by X-ray absorptiometry dual energy.

Secondary Outcome(s)

Significant increase in lower limbs muscle mass in the assessment before and after intervention period assessed by X-ray absorptiometry dual energy.

Significant increase of overall muscle function in the assessment before and after intervention period assessed by handgrip strength.

Source(s) of Monetary Support

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Secondary Sponsor(s)

Hospital das Clínicas da Faculdade de Medicina de Botucatu