Effects of a Resistance Training Program on Heart Rate Variability in Children and Adolescents With Cystic Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Change in the root mean square standard deviation (RMSSD) expressed in milliseconds (m/s)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change in the root mean square standard deviation (RMSSD) expressed in milliseconds (m/s)
Time Frame: 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 high frequency band (HF) expressed in normalized unites (nu)
Time Frame: 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)
Time Frame: 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 percentage of differences between R-R intervals higher than 50 m/s (PNN50) expressed in percentage (%)
Time Frame: 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.
Change in the low frequency band (LF) expressed in normalized unites (nu)
Time Frame: 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 quotient (LF/HF) between the low frequency band (LF) and the high frequency band (HF) expressed as a ratio
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Margarita Perez
Full Professor In Exercise Physiology, MD, PhD
Universidad Europea de Madrid