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Effects of Physical Activity Counseling After an Exacerbation in COPD

30. april 2015 opdateret af: Marc Decramer, KU Leuven

The Effects of a Physical Activity Counseling Program Immediately After an Exacerbation in Patients With COPD.

Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant a hospitalization. During the hospitalization, patients are extremely physically inactive with only a limited recovery one month after discharge. Physical inactivity is associated with negative health benefits. Therefore intervening in the period after and exacerbation seems useful to improve the levels of physical activity. Physical activity counseling and real-time feedback have already been applied in stable patients with COPD, with beneficial effects.The present study will investigate whether this specific intervention will help to improve the activity level in patients after an acute exacerbation. Further we investigated the effects of the intervention on improvements in functional exercise capacity.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

After signing the informed consent, the patients will be randomized into a control group, receiving usual care, or the intervention group receiving real-time feedback and physical activity counseling.

Intervention: Physical activity counseling will be provided by 3 weekly telephone contacts based on the step count from the Fitbit Ultra. In agreement with the patient and based on the step counts a patients provided, a new goal for the next week was set. The goal was to strive for the highest possible level of physical activity during one month.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Leuven, Belgien, 3000
        • University Hospital Leuven

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

40 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Signed Informed Consent
  • Chronic Obstructive Lung Disease (Tiff<70%)
  • Hospitalized because of exacerbation
  • Capable of working with electronic devices

Exclusion Criteria:

  • Orthopedic/Neurologic problems making it difficult to be active
  • Participation in a rehabilitation program

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Physical activity
The fitbit Ultra was used to provide real-time feedback on physical activity. An experienced physiotherapist contacted the subjects 3 times a week to receive information about the amount of steps from the previous days. In agreement with the patient, a new goal for the coming weeks was set and patients were motivated to achieve their individual goal.
Adfærdsmæssigt: Physical activity
Counseling about physical activity will only be provided in the intervention group by 3 weekly telephone contacts. Based on the information the physiotherapist receives, he or she will adapt the goal (in agreement with the patient) and motivate the patient to reach the individual goal.
Placebo komparator: Usual Care
During the hospital stay, the patients in the control group will be informed about the beneficial effects of being physically inactive.They will not receive feedback about their activities performed and will not be stimulated to become more active.
Adfærdsmæssigt: Physical activity
Counseling about physical activity will only be provided in the intervention group by 3 weekly telephone contacts. Based on the information the physiotherapist receives, he or she will adapt the goal (in agreement with the patient) and motivate the patient to reach the individual goal.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in physical activity
Tidsramme: 1 month
The Dynaport MoveMonitor, a valid device in patients with COPD, was used to accurately measure the level of physical activity. The device was provided 3 times to the patients (baseline, after 2 weeks, after 1 month). The amount of steps, measured by this device, was used as the outcome measure.
1 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in functional exercise capacity
Tidsramme: 1 month
Functional exercise capacity was measured by the six minutes walking distance test (6MWD; meter). This measurement was performed at baseline and after 1 month.
1 month

Samarbejdspartnere og efterforskere

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

Sponsor

KU Leuven

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.

Generelle publikationer

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 2013

Primær færdiggørelse (Faktiske)

1. april 2014

Studieafslutning (Faktiske)

1. maj 2014

Datoer for studieregistrering

Først indsendt

4. september 2013

Først indsendt, der opfyldte QC-kriterier

21. august 2014

Først opslået (Skøn)

22. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • S55086
  • ML8991 (Anden identifikator: University Hospital Leuven)

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 KOL eksacerbation

Kliniske forsøg med Physical activity

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