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Heart Rate Variability in Children and Adolescents With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04293926
Recruitment Status : Completed
First Posted : March 3, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Margarita Perez, Universidad Europea de Madrid

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis in Children Other: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Resistance Training Program on Heart Rate Variability in Children and Adolescents With Cystic Fibrosis
Actual Study Start Date : March 5, 2020
Actual Primary Completion Date : September 7, 2020
Actual Study Completion Date : September 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
No Intervention: Control
This group will receive routine recommendations by the pediatrician, including specific lifestyle advises.
Experimental: Exercise
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.
Other: Exercise
Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293926


Locations
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Spain
Escuela de Doctorado e Investigacion, Universidad Europea
Villaviciosa De Odón, Madrid, Spain, 28670
Sponsors and Collaborators
Universidad Europea de Madrid
Investigators
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Principal Investigator: Margarita Perez Ruiz, PhD Universidad Europea de Madrid
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Margarita Perez, Full Professor In Exercise Physiology, MD, PhD, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT04293926    
Other Study ID Numbers: UEM50
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margarita Perez, Universidad Europea de Madrid:
Cystic Fibrosis
Heart Rate Variability
Exercise
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases