Heart Rate Variability in Children and Adolescents With Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-05

Study Completion Date

2020-09-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration.

Interventions

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Exercise

Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No