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NCT Number: NCT04293926

Heart Rate Variability in Children and Adolescents With Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis in Children Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Motor Activity Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escuela de Doctorado e Investigacion, Universidad Europea

Villaviciosa de Odón, Madrid, 28670, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  1. Change in the forced expiratory volume in one second (FEV1) expressed as z-score

    Time frame: Baseline and 8 weeks

    Changes in FEV1 will be measured using spirometry

  2. Change in the forced vital capacity (FVC) expressed as z-score

    Time frame: Baseline and 8 weeks

    Changes in FVC will be measured using spirometry

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Effects of a Resistance Training Program on Heart Rate Variability in Children and Adolescents With Cystic Fibrosis

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2020
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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