Cystic Fibrosis in Children
Conditions
Keywords
Cystic Fibrosis, Heart Rate Variability, Exercise
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.
Interventions
OTHERExercise
Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration.
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the quotient (LF/HF) between the low frequency band (LF) and the high frequency band (HF) expressed as a ratio | Baseline and 8 weeks | 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 low frequency band (LF) expressed in normalized unites (nu) | Baseline and 8 weeks | 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) | Baseline and 8 weeks | 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 standard deviation of R-R intervals (SDNN) expressed in milliseconds (m/s) | Baseline and 8 weeks | 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) | Baseline and 8 weeks | 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 (%) | Baseline and 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the forced vital capacity (FVC) expressed as z-score | Baseline and 8 weeks | Changes in FVC will be measured using spirometry |
| Change in the forced expiratory volume in one second (FEV1) expressed as z-score | Baseline and 8 weeks | Changes in FEV1 will be measured using spirometry |
Countries
Spain
Outcome results
None listed