Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Efficacy of Arm Training in COPD Patients (UEET-COPD)

2. august 2011 opdateret af: Villa Pineta Hospital

Effects of Unsupported Upper Extremity Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial

Recent guidelines on pulmonary rehabilitation (PR) recommend upper extremity exercise training (UEET) in patients with chronic obstructive pulmonary disease (COPD).

The theory supporting the inclusion of upper extremity exercise training in the pulmonary rehabilitation for these patients, is based on the profound understanding of the activity of the accessory respiratory muscles, which are competitively involved in both the support of the upper extremities during activities and the ventilation. However, a systematic review of the literature carried out by our staff reveals that the clinical trials carried out up to now to verify the effectiveness of UEET are of poor methodological quality and the investigators cannot corroborate the recommendation recently made on the basis of the results of the investigators' review.

Therefore the investigators began this randomized, parallel groups, controlled clinical trial with the purpose of determining the short-term effect of unsupported UEET on the performance of the upper extremities and on symptoms perceived during activities by patients with COPD.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

We recruited inpatients with stable, moderate or severe COPD referred to the PR program at the regional centre of Villa Pineta Hospital.

Patients were randomized into two groups: control and intervention. Patients randomized to the control group undertook an inpatient comprehensive PR that complied with the recommendations made by the ATS/ERS and included a minimum of 15 daily sessions of specific training for lower extremities.

Patients randomized to the intervention group undertook an experimental program consisting of 15 additional daily sessions of unsupported UEET over and above the same PR program used for control patients.

Measurements of upper extremity performance and symptoms perceived were taken in both groups at baseline (T0) and at the completion of the interventions (Tend) by one physiotherapist unaware to the patient's group allocation. To verify if the experimental training leads to long-term results on the functional arm exercise capacity, some measurements were repeated at 6-months as the latest follow-up (T6months).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Italien
    • Modena
      • Pavullo nel Frignano, Modena, Italien, 41026
        • Villa Pineta Hospital

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • diagnosis of COPD
  • a degree of COPD severity equal or above grade 2 (moderate) on the basis of the GOLD classification
  • clinical stability for a minimum of 4 weeks
  • degree of chronic dyspnea ≥ grade 2 on the Medical Research Council Dyspnea Scale

Exclusion Criteria:

  • muscular-skeletal abnormalities limiting the shoulder girdle functionality
  • cognitive impairment limiting participation
  • previous inclusion in UEET programmes within the last 3 years
  • malignancies

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
Aktiv komparator: 1: comprehensive PR
Inpatient comprehensive PR program that lasted lasted 3 weeks and included a minimum of 15 daily sessions of specific training for lower extremities, education, nutritional intervention, psychosocial intervention. It complied with the recommendation of the ATS/ERS.
Procedure: comprehensive PR
Inpatient comprehensive PR program that lasted lasted 3 weeks and included a minimum of 15 daily sessions of specific training for lower extremities, education, nutritional intervention, psychosocial intervention. It complied with the recommendation of the ATS/ERS.
Andre navne:
  • Lungerehabilitering
Eksperimentel: 2: UEET + PR
Experimental program consisting in additional 15 daily sessions of unsupported UEET over and above the same PR program used for control patients.
Procedure: UEET
Experimental program consisting of 15 additional daily sessions of unsupported UEET.
Andre navne:
  • Upper extremity exercise training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
6-min. ring test (6MRT)
Tidsramme: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
T0=baseline, Tend (week three) , T6months (six months after the completion of the training)

Sekundære resultatmål

Resultatmål
Tidsramme
ADL field test
Tidsramme: T0=baseline, Tend (week three)
T0=baseline, Tend (week three)
LCADL
Tidsramme: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
MRC
Tidsramme: T0=baseline, Tend (week three)
T0=baseline, Tend (week three)
6MWT
Tidsramme: T0=baseline, Tend (week three)
T0=baseline, Tend (week three)

Samarbejdspartnere og efterforskere

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

Sponsor

Villa Pineta Hospital

Samarbejdspartnere

University of Modena and Reggio Emilia

Efterforskere

  • Ledende efterforsker: Stefania Costi, Dr, University of Modena and Reggio Emilia
  • Studiestol: Enrico M Clini, Professor, Villa Pineta Hospital and University of Modena and Reggio Emilia

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 2007

Primær færdiggørelse (Faktiske)

1. oktober 2007

Studieafslutning (Faktiske)

1. april 2008

Datoer for studieregistrering

Først indsendt

15. januar 2009

Først indsendt, der opfyldte QC-kriterier

16. januar 2009

Først opslået (Skøn)

19. januar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. august 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. august 2011

Sidst verificeret

1. maj 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UEET0307

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 .

Abonner