Heart Rate Variability in Children and Adolescents With Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis in Children
• Interventions: Other: Exercise

• Registration Number: NCT04293926
• Lead Sponsor: Universidad Europea de Madrid

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-03
• Study Start: 2020-03-05
• Status Verified: 2020-09
• Primary Completion: 2020-09-07
• Study Completion: 2020-09-07
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	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.

Primary Outcome Measures

Name	Time	Method
Change in the root mean square standard deviation (RMSSD) expressed in milliseconds (m/s)	Baseline and 8 weeks	Changes in time-domain RMSSD will be measured through heart rate variability assessment using a heart rate band and an Ambit 3 Sport watch. Variables will be collected during a five minute period.
Change in the high frequency band (HF) expressed in normalized unites (nu)	Baseline and 8 weeks	Changes in frequency-domain HF will be measured through heart rate variability assessment using a heart rate band and an Ambit 3 Sport watch. Variables will be collected during a five minute period.
Change in the standard deviation of R-R intervals (SDNN) expressed in milliseconds (m/s)	Baseline and 8 weeks	Changes in time-domain SDNN will be measured through heart rate variability assessment using a heart rate band and an Ambit 3 Sport watch. Variables will be collected during a five minute period.
Change in the percentage of differences between R-R intervals higher than 50 m/s (PNN50) expressed in percentage (%)	Baseline and 8 weeks	Changes in time-domain PNN50 will be measured through heart rate variability assessment using a heart rate band and an Ambit 3 Sport watch. Variables will be collected during a five minute period.
Change in the low frequency band (LF) expressed in normalized unites (nu)	Baseline and 8 weeks	Changes in frequency-domain LF will be measured through heart rate variability assessment using a heart rate band and an Ambit 3 Sport watch. Variables will be collected during a five minute period.
Change in the quotient (LF/HF) between the low frequency band (LF) and the high frequency band (HF) expressed as a ratio	Baseline and 8 weeks	Changes in frequency-domain HF will be measured through heart rate variability assessment using a heart rate band and an Ambit 3 Sport watch. Variables will be collected during a five minute period.

Secondary Outcome Measures

Name	Time	Method
Change in the forced expiratory volume in one second (FEV1) expressed as z-score	Baseline and 8 weeks	Changes in FEV1 will be measured using spirometry
Change in the forced vital capacity (FVC) expressed as z-score	Baseline and 8 weeks	Changes in FVC will be measured using spirometry

Trial Locations

Locations (1)

Escuela de Doctorado e Investigacion, Universidad Europea; 🇪🇸 Villaviciosa De Odón, Madrid, Spain