Heart Rate Variability in Children and Adolescents With Cystic Fibrosis

Cystic Fibrosis in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293926
• Other study ID #: UEM50
• Status: Completed
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: September 7, 2020

Study information

• Verified date: September 2020
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 7, 2020
• Est. primary completion date: September 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis in Children
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
Spain	Escuela de Doctorado e Investigacion, Universidad Europea	Villaviciosa De Odón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Change in the forced vital capacity (FVC) expressed as z-score	Changes in FVC will be measured using spirometry	Baseline and 8 weeks