Heart Rate Variability in Children and Adolescents With Cystic Fibrosis

Study Overview
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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.

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.

Official Title
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Effects of a Resistance Training Program on Heart Rate Variability in Children and Adolescents With Cystic Fibrosis

Conditions
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Cystic Fibrosis in Children

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>This group will receive routine recommendations by the pediatrician, including specific lifestyle advises. | |
| Experimental: Exercise<br>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. | Other: Exercise<br>* Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the standard deviation of R-R intervals (SDNN) expressed in milliseconds (m/s) | 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. | Baseline and 8 weeks | 
| Change in the root mean square standard deviation (RMSSD) expressed in milliseconds (m/s) | 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. | Baseline and 8 weeks | 
| Change in the percentage of differences between R-R intervals higher than 50 m/s (PNN50) expressed in percentage (%) | 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. | Baseline and 8 weeks | 
| Change in the low frequency band (LF) expressed in normalized unites (nu) | 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. | Baseline and 8 weeks | 
| Change in the high frequency band (HF) expressed in normalized unites (nu) | 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. | Baseline and 8 weeks | 
| Change in the quotient (LF/HF) between the low frequency band (LF) and the high frequency band (HF) expressed as a ratio | 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. | Baseline and 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Heart Rate Variability, Exercise