Heart Rate Variability in Children and Adolescents With Cystic Fibrosis
17. september 2020 opdateret af: Margarita Perez, Universidad Europea de Madrid
Effects of a Resistance Training Program on 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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
19
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Madrid
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Villaviciosa De Odón, Madrid, Spanien, 28670
- Escuela de Doctorado e Investigacion, Universidad Europea
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Control
This group will receive routine recommendations by the pediatrician, including specific lifestyle advises.
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|
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Eksperimentel: 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.
|
Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the standard deviation of R-R intervals (SDNN) expressed in milliseconds (m/s)
Tidsramme: 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.
|
Baseline and 8 weeks
|
|
Change in the root mean square standard deviation (RMSSD) expressed in milliseconds (m/s)
Tidsramme: 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.
|
Baseline and 8 weeks
|
|
Change in the percentage of differences between R-R intervals higher than 50 m/s (PNN50) expressed in percentage (%)
Tidsramme: 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.
|
Baseline and 8 weeks
|
|
Change in the low frequency band (LF) expressed in normalized unites (nu)
Tidsramme: 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.
|
Baseline and 8 weeks
|
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Change in the high frequency band (HF) expressed in normalized unites (nu)
Tidsramme: 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.
|
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
Tidsramme: 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.
|
Baseline and 8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the forced expiratory volume in one second (FEV1) expressed as z-score
Tidsramme: Baseline and 8 weeks
|
Changes in FEV1 will be measured using spirometry
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Baseline and 8 weeks
|
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Change in the forced vital capacity (FVC) expressed as z-score
Tidsramme: Baseline and 8 weeks
|
Changes in FVC will be measured using spirometry
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Baseline and 8 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Margarita Perez Ruiz, PhD, Universidad Europea de Madrid
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. marts 2020
Primær færdiggørelse (Faktiske)
7. september 2020
Studieafslutning (Faktiske)
7. september 2020
Datoer for studieregistrering
Først indsendt
25. februar 2020
Først indsendt, der opfyldte QC-kriterier
2. marts 2020
Først opslået (Faktiske)
3. marts 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UEM50
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