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Short Active Lives Survey in Chronic Lung Conditions

26. april 2021 opdateret af: University of Lincoln

Short Active Lives Survey in Chronic Lung Conditions: an Exploratory Study

Short Actives Lives Survey is a common tool used to measure physical activity in the UK population. Self-reported measures such as the Short Active Lives Survey can be prone to bias. As such, during project evaluations, benefits may be exaggerated due to over-reporting of physical activity or downplayed due to underreporting of physical activity. There is also a lack of research reporting the typical short-term and long-term changes in physical activity (measured by the Short Active Lives Survey) in people with chronic lung conditions who are not receiving support to become active (i.e. usual care, control groups). Accelerometers are small lightweight activity monitors that can be worn on the waist. These monitors are known to provide accurate and reliable objective assessment of physical activity in people with lung conditions.

This research study will recruit a cohort of inactive people with lung conditions and determine changes in physical activity measured by both the Short Active Lives Survey and one of the most valid accelerometers used in people with lung conditions (Actigraph GT3X). The study will also evaluate how these physical activity measures relate to general health (health status and health care use) of people with lung conditions over 12 months. This study will provide information on the usefulness of using the Short Active Lives Survey in the future for measuring physical activity in people with lung conditions.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

80

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Lincolnshire
      • Lincoln, Lincolnshire, Det Forenede Kongerige, LN6 7TS
        • University of Lincoln

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

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The eligibility criteria has been designed to be as broad as possible so that findings can be generalisable to the wider population of inactive people with lung conditions. The main study population will be recruited via convenience sampling at the participant identification centres within Lincolnshire Community Health Services, South Lincolnshire CCG, South West Lincolnshire CCG, Lincolnshire East CCG, Lincolnshire West CCG and United Lincolnshire Hospitals NHS Trust.

Beskrivelse

Inclusion Criteria:

  • Diagnosis of Chronic Obstructive Pulmonary Disease, Bronchiectasis, Interstitial Lung Disease, Lung Cancer, Mesothelioma or Asthma
  • Physically inactive defined as completing less than 30 minutes ore more of moderate intensity equivalent physical activity per week (measured by the Short Active Lives Survey)

Exclusion Criteria:

  • Adults without a diagnosis of Chronic Obstructive Pulmonary Disease, Bronchiectasis, Interstitial Lung Disease, Lung Cancer, Mesothelioma or Asthma
  • Age < 18 Years
  • Completing 30 minutes or more of moderate intensity equivalent (MIE) physical activity per week
  • Inability or unwillingness to sign informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Usual Care
People with a chronic lung condition who are physically inactive

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Minutes of self-reported moderate intensity equivalent physical activity per week
Tidsramme: Baseline to 12 months
Short Active Lives Survey
Baseline to 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Accelerometer measured physical activity: time (minutes per day) spent in moderate intensity activity
Tidsramme: Baseline to 12 months
Actigraph wGT3X-BT
Baseline to 12 months
Accelerometer measured physical activity: time (minutes per week) spent in light activity
Tidsramme: Baseline to 12 months
Actigraph wGT3X-BT
Baseline to 12 months
Accelerometer measured physical activity including: time (minutes per week) spent in vigorous activity
Tidsramme: Baseline to 12 months
Actigraph wGT3X-BT
Baseline to 12 months
Accelerometer measured physical activity: time (minutes per day) spent in sedentary state
Tidsramme: Baseline to 12 months
Actigraph wGT3X-BT
Baseline to 12 months
Accelerometer measured physical activity: average daily steps
Tidsramme: Baseline to 12 months
Actigraph wGT3X-BT
Baseline to 12 months
Accelerometer measured physical activity including: daily vector magnitude units
Tidsramme: Baseline to 12 months
Actigraph wGT3X-BT
Baseline to 12 months
EQ5D index
Tidsramme: Baseline to 12 months
Based on self-rating of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension is rated between 1 (no problems) to 5 (unable to/extreme problems). Dimensions are combined to produce a five-digit number describing the individual's health status (ranging from 11111 to 55555). Five digit number converted to an index based on the EQ-5D-5L value set for England. Index ranges from -0.208 (worst possible health) to 1.000 (best possible health).
Baseline to 12 months
EQ VAS
Tidsramme: Baseline to 12 months
Self-report of health status on a scale, 0 (worst health) - 100 (best health)
Baseline to 12 months
Cost questionnaire
Tidsramme: Baseline to 12 months
NHS resource use questionnaire
Baseline to 12 months
Demographics:
Tidsramme: Baseline to 12 months
Age, gender, ethnicity, comorbidities, social deprivation, MRC degree of breathlessness, oxygen use
Baseline to 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Arwel W Jones, PhD, University of Lincoln

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)

1. august 2019

Primær færdiggørelse (Faktiske)

30. november 2020

Studieafslutning (Faktiske)

31. december 2020

Datoer for studieregistrering

Først indsendt

3. september 2019

Først indsendt, der opfyldte QC-kriterier

3. september 2019

Først opslået (Faktiske)

6. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2021

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 190501

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lungesygdomme

3
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