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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | This group will receive routine recommendations by the pediatrician, including specific lifestyle advises. | |
| Exercise | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in the forced vital capacity (FVC) expressed as z-score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margarita Perez Ruiz, PhD | Universidad Europea de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escuela de Doctorado e Investigacion, Universidad Europea | Villaviciosa de Odón | Madrid | 28670 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33859572 | Derived | 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. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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 |
Changes in FVC will be measured using spirometry
| Baseline and 8 weeks |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001519 | Behavior |