Heart Rate Variability in Children and Adolescents With Cystic Fibrosis
Effects of a Resistance Training Program on Heart Rate Variability in Children and Adolescents With Cystic Fibrosis
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2020
CompletedStudy Start
First participant enrolled
March 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2020
CompletedSeptember 18, 2020
September 1, 2020
6 months
February 25, 2020
September 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (2)
Change in the forced expiratory volume in one second (FEV1) expressed as z-score
Baseline and 8 weeks
Change in the forced vital capacity (FVC) expressed as z-score
Baseline and 8 weeks
Study Arms (2)
Control
NO INTERVENTIONThis group will receive routine recommendations by the pediatrician, including specific lifestyle advises.
Exercise
EXPERIMENTALThis group will receive routine recommendations by the pediatrician, including specific lifestyle advises. In addition, a 8-week resistance exercise training program will be performed.
Interventions
Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Active smoking
- Exacerbation in the last 3 months
- Presence of gastrostomy
- Use of beta-blocker drugs
- Diagnosed heart disease
- Alterations in the locomotor system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Escuela de Doctorado e Investigacion, Universidad Europea
Villaviciosa de Odón, Madrid, 28670, Spain
Related Publications (1)
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.
PMID: 33859572DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margarita Perez Ruiz, PhD
Universidad Europea de Madrid
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor In Exercise Physiology, MD, PhD
Study Record Dates
First Submitted
February 25, 2020
First Posted
March 3, 2020
Study Start
March 5, 2020
Primary Completion
September 7, 2020
Study Completion
September 7, 2020
Last Updated
September 18, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share