Heart Rate Variability in Children and Adolescents With Cystic Fibrosis

European University

Status: Completed

Conditions: Cystic Fibrosis in Children

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04293926

UEM50

Details and patient eligibility

About

This study aims to assess the effects of a resistance exercise training program on heart rate variability in a group of children and adolescents with cystic fibrosis. The study design is a randomized controlled trial.

Full description

A randomized controlled study will be carried out in children diagnosed with cystic fibrosis aged 6 to 18 years. Individuals will be divided into two groups: control group (CON) and strength training (ST). Heart rate variability will be analyzed using KUBIOS and measured using a Suunto watch, with subjects in lying position without movements or speaking for 5 minutes. Patients in the ST group will complete an individualized guided strength program for 8 weeks (3 sessions of 60 min/week). Training prescription will be individualized and based on the 5 repetition maximum test (60-80%). Upper and lower limbs exercises will be used, including seated bench press, seated lateral row and leg press. Outcome measures will be performed at baseline and after 8 weeks.

Enrollment: 19 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Cystic Fibrosis
• Age between 6 and 18 years old
• Mild to moderate lung function levels
• Signature of the informed consent form by legal guardian and patient.

Exclusion criteria

• Active smoking
• Exacerbation in the last 3 months
• Presence of gastrostomy
• Use of beta-blocker drugs
• Diagnosed heart disease
• Alterations in the locomotor system

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Control

No Intervention group

Description:

This group will receive routine recommendations by the pediatrician, including specific lifestyle advises.

Exercise

Experimental group

Description:

This group will receive routine recommendations by the pediatrician, including specific lifestyle advises. In addition, a 8-week resistance exercise training program will be performed.

Treatment:

Other: Exercise