Heart Rate Variability in Children and Adolescents With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis in Children
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis in Children focused on measuring Cystic Fibrosis, Heart Rate Variability, Exercise
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
Sites / Locations
- Escuela de Doctorado e Investigacion, Universidad Europea
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Exercise
Arm Description
This group will receive routine recommendations by the pediatrician, including specific lifestyle advises.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Change in the forced expiratory volume in one second (FEV1) expressed as z-score
Changes in FEV1 will be measured using spirometry
Change in the forced vital capacity (FVC) expressed as z-score
Changes in FVC will be measured using spirometry
Full Information
NCT ID
NCT04293926
First Posted
February 25, 2020
Last Updated
September 17, 2020
Sponsor
Universidad Europea de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04293926
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
September 7, 2020 (Actual)
Study Completion Date
September 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis in Children
Keywords
Cystic Fibrosis, Heart Rate Variability, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive routine recommendations by the pediatrician, including specific lifestyle advises.
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration.
Primary Outcome Measure Information:
Title
Change in the standard deviation of R-R intervals (SDNN) expressed in milliseconds (m/s)
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in the root mean square standard deviation (RMSSD) expressed in milliseconds (m/s)
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in the percentage of differences between R-R intervals higher than 50 m/s (PNN50) expressed in percentage (%)
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in the low frequency band (LF) expressed in normalized unites (nu)
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in the high frequency band (HF) expressed in normalized unites (nu)
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in the quotient (LF/HF) between the low frequency band (LF) and the high frequency band (HF) expressed as a ratio
Description
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.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in the forced expiratory volume in one second (FEV1) expressed as z-score
Description
Changes in FEV1 will be measured using spirometry
Time Frame
Baseline and 8 weeks
Title
Change in the forced vital capacity (FVC) expressed as z-score
Description
Changes in FVC will be measured using spirometry
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita Perez Ruiz, PhD
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escuela de Doctorado e Investigacion, Universidad Europea
City
Villaviciosa De Odón
State/Province
Madrid
ZIP/Postal Code
28670
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33859572
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.
Results Reference
derived
Learn more about this trial
Heart Rate Variability in Children and Adolescents With Cystic Fibrosis
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