Exercise Training Study for Patients With Cystic Fibrosis
18. februar 2016 opdateret af: David Orenstein, University of Pittsburgh
Self-Regulated Exercise in CF: A Randomized Trial
The aim of this study is to test the effect of a 6-month program of self-regulated, home-based exercise with telephone reinforcement on the cardiorespiratory fitness, pulmonary function and health-related quality of life of children with cystic fibrosis (CF), compared to controls.
Exploring the exercise experiences of the children and parents is a secondary aim.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
CF is a life-long illness that requires complex and dynamic adjustment by the patient and family.
The nursing role is vital to the multidisciplinary team approach required in providing comprehensive, individualized care for these patients.
Nurses facilitate the coordination of health care efforts and support the patient and family across physical and psychosocial domains.
With the well-documented correlation between exercise tolerance and both survival and HRQoL, exercise represents a critical treatment focus for CF patients.
Nurses contribute to standard exercise rehabilitation programs, through education, psychosocial support, and communication.
In this exercise training study, the nursing role will include: a) teaching the patients and families how to use the OMNI scale, b) confirming that they understand the home-based exercise regimen, and c) ensuring that the home-care program is properly followed by placing weekly telephone calls to assess progress and barriers.
Long-term nursing application will occur via dissemination of the OMNI training manual, to be developed as part of this study, for use by CF nurses in clinics worldwide.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
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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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Antiono J & Janet Palumbo Cystic Fibrosis Center; Children's Hospital of Pittsburgh of UPMC
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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
10 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- CF diagnosis
- age 10-18 years
- reliable pulmonary function tests
- living at home
- able to read
- able to ride a stationary bike
- able to walk and/or run on a treadmill.
Exclusion Criteria:
- Enrolled in another intervention study
- in structured aerobic activity for 30 continuous minutes 3 times per week
- sibling enrolled in study.
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: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 1
Self-Regulated Exercise with Telephone Reinforcement
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The self-regulated exercise with telephone reinforcement group will engage in a three-times-a-week (or more) at home exercise regimen for 6 months during which they may choose the mode of exercise.
They will receive weekly telephone calls about exercise and airway clearance.
After 6 months, they will be instructed to maintain their self-regulated exercise activity for the remaining 6 months of the study, but they will not receive telephone calls
A qualitative naturalistic approach is nested within the primary experimental framework to explore the experiences of the children and parents, in both groups, with the exercise regimen.
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Aktiv komparator: 2
Attention Control
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A qualitative naturalistic approach is nested within the primary experimental framework to explore the experiences of the children and parents, in both groups, with the exercise regimen.
The attention control group will receive standard recommendations for exercise activity, during the first 6 months, as is common in our clinic.
Also during the first 6 months, they will receive weekly telephone calls about airway clearance.
For the final 6 months of the study, the attention control group will cross over to self-regulated exercise without telephone reinforcement.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Cardiopulmonary Fitness: Peak VO2
Tidsramme: 1 year
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1 year
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Cardiopulmonary fitness: VO2150 and peak power output
Tidsramme: 1 year
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1 year
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Pulmonary function: FEV1 and sustained phonation time
Tidsramme: 1 year
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1 year
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Health-related quality of life: Quality of well-being scale and cystic fibrosis questionnaire
Tidsramme: 1 Year
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1 Year
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Exercise experiences of children and parents: Interviews
Tidsramme: 1 Year
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1 Year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: David M Orenstein, MD, University of Pittsburgh
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
1. marts 2007
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. december 2010
Datoer for studieregistrering
Først indsendt
31. januar 2008
Først indsendt, der opfyldte QC-kriterier
1. februar 2008
Først opslået (Skøn)
6. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. februar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. februar 2016
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01NR009285 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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