Clinical trial NCT04293926: Heart Rate Variability in Children and Adolescents With Cystic Fibrosis
Official title: Effects of a Resistance Training Program on Heart Rate Variability in Children and Adolescents With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis in Children
Keywords: Cystic Fibrosis
Heart Rate Variability
Exercise
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 19
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the standard deviation of R-R intervals (SDNN) expressed in milliseconds (m/s)
timeFrame: Baseline and 8 weeks
measure: Change in the root mean square standard deviation (RMSSD) expressed in milliseconds (m/s)
timeFrame: Baseline and 8 weeks
measure: Change in the percentage of differences between R-R intervals higher than 50 m/s (PNN50) expressed in percentage (%)
timeFrame: Baseline and 8 weeks
measure: Change in the low frequency band (LF) expressed in normalized unites (nu)
timeFrame: Baseline and 8 weeks
measure: Change in the high frequency band (HF) expressed in normalized unites (nu)
timeFrame: Baseline and 8 weeks
measure: Change in the quotient (LF/HF) between the low frequency band (LF) and the high frequency band (HF) expressed as a ratio
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in the forced expiratory volume in one second (FEV1) expressed as z-score
timeFrame: Baseline and 8 weeks
measure: Change in the forced vital capacity (FVC) expressed as z-score
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Villaviciosa De Odón
country: Spain
facility: Escuela de Doctorado e Investigacion, Universidad Europea
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Margarita Perez Ruiz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Estevez-Gonzalez AJ, Donadio MVF, Cobo-Vicente F, Fernandez-Luna A, Sanz-Santiago V, Villa Asensi JR, Iturriaga Ramirez T, Fernandez-Del-Valle M, Diez-Vega I, Larumbe-Zabala E, Perez-Ruiz M. Effects of a Short-Term Resistance-Training Program on Heart Rate Variability in Children With Cystic Fibrosis-A Randomized Controlled Trial. Front Physiol. 2021 Mar 30;12:652029. doi: 10.3389/fphys.2021.652029. eCollection 2021.