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
NCT number | NCT04293926 |
Other study ID # | UEM50 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 5, 2020 |
Est. completion date | September 7, 2020 |
Verified date | September 2020 |
Source | Universidad Europea de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Escuela de Doctorado e Investigacion, Universidad Europea | Villaviciosa De Odón | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Europea de Madrid |
Spain,
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 |
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