Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Physical Activity and Self-Efficacy After Pulmonary Rehabilitation

27 mei 2014 bijgewerkt door: Noor Diana Binte Mohamed Sani, University College, London

Short Term Effects of Pulmonary Rehabilitation on Level of Physical Activity and Self-Efficacy in Patients With Chronic Obstructive Pulmonary Disease.

The purpose of this study is to investigate whether pulmonary rehabilitation (PR) is effective in increasing level of (a) physical activity (PA) and (b) self-efficacy in patients with chronic obstructive pulmonary disease (COPD).

PR is an evidence-based multidisciplinary approach consisting primarily of a supervised exercise program with educational components. It has demonstrated high efficacy in improving dyspnoea, health-related quality of life (HRQoL) and functional exercise capacity in patients with COPD. Despite these improvements, there is no conclusive evidence that these benefits translate to an increase in PA in patient's day-to-day life. This is of concern as low PA is a predictor of all cause mortality, correlated with lower HRQoL, increased level of dyspnoea and higher number of hospital admissions in this group of patients.

Self-efficacy is found to be an instigating force in forming intention to exercise and in maintaining practice for an extended time. Self-efficacy may be the key in determining whether a patient translates the improvement in exercise tolerance to actually being more physically active. Based on current knowledge, there is insufficient evidence that self-efficacy increases after pulmonary rehabilitation and no correlation has been made between level of self-efficacy and level of PA in these group of patients.

Hence this study aims to find out whether the existing PR program increases level of PA and self-efficacy. Correlation between level of PA and self-efficacy will be made.

Studie Overzicht

Toestand

Onbekend

Conditie

Chronische obstructieve longziekte

Gedetailleerde beschrijving

The intervention group will consist of all patients with chronic obstructive pulmonary disease (COPD) referred to Guy's and St Thomas' Hospital (GSTT) pulmonary rehabilitation. A sample of 30 is anticipated as this is the maximum number of patients who could be enrolled in the 3 month recruitment period in Guy's and St. Thomas' Hospital.

The patient information sheet, together with the referral for PR, will be posted to the patients. Patients will be informed about the study details in the patient information sheet. This will include the fact that they have to wear an accelerometer for 5 to 7 days prior to starting the program. These accelerometers will be collected thereafter. Instructions on the use of the accelerometers will be given. They will also be informed that any personal information will strictly be kept confidential and that the results will be used for analysis in the study.
Written consent will be taken on initial assessment if patient agrees to participate in the study.
The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire will be administered. It consists of 15 questions and will take less than 10 minutes to complete.
The patient will undertake 14 sessions of PR under supervision to successfully complete the program. The program is held at Guy's and St Thomas' Hospital.
The PRAISE questionnaire will be administered again after completion of the program. Patients will be asked to wear the accelerometers again to track their physical activity. After 5 to 7 days of use, the accelerometers will be collected either from their address or via stamped postage.

No changes will be made to the current pulmonary rehabilitation program.

No control group is present in the study as pulmonary rehabilitation is the standard of care and it is not ethical to withhold pulmonary rehabilitation from patients with COPD.

The null hypothesis would be that there is no difference in physical activity and self-efficacy before and after pulmonary rehabilitation. The statistical test used will be a paired sample t-test to determine the change in a) physical activity and b)self-efficacy after pulmonary rehabilitation.

Correlation analysis will be made between self-efficacy and physical activity with a) Anxiety and depression (Hospital anxiety and depression scale), b)Functional exercise capacity (6 minute walk test) and c) COPD Assessment test.

A Pearson or Spearman correlations will be done depending on whether or not the data is normally distributed.

Studietype

Observationeel

Inschrijving (Verwacht)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigd Koninkrijk
- London
  - City of Westminster, London, Verenigd Koninkrijk, SE1 7EH
    - Werving
    - St. Thomas' Hospital
    - Contact:
      
      Noor Diana Mohamed Sani
      
      Telefoonnummer: 4407852599168
      
      E-mail: noor.sani.13@ucl.ac.uk
    - Hoofdonderzoeker:
      
      Noor Diana Mohamed Sani

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

This study involves patients with chronic obstructive pulmonary disease (COPD), whose diagnosis is confirmed by spirometry

Beschrijving

Inclusion Criteria:

Patients who fulfill the current inclusion criteria for referral to pulmonary rehabilitation in Guy's and St Thomas' Hospital.
- Have chronic obstructive pulmonary disease or other respiratory conditions.
- Are aware of the about the referral and details of the program.
- Have consented and are able to attend the program.
A diagnosis of COPD confirmed by spirometry (Forced Expiratory Volume in 1 second/Forced Vital Capacity < 0.70 after bronchodilator) (GOLD, 2014)

Exclusion Criteria:

No evidence of COPD on spirometry
Acute exacerbations within last 4-6 weeks requiring hospital admission
Evidence of ischemic heart disease/ acute changes on ECG
Uncontrolled hypertension
Inability to exercise independently or musculoskeletal/neurological conditions which would prevent completion of the course or limit participation in the course
Lung cancer

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Patients with COPD This is an observational study of patients with chronic obstructive pulmonary disease (COPD) who attend pulmonary rehabilitation, which is the routine standard of care in Guy's and St. Thomas' Hospital, London. It lasts for 14 sessions, twice a week and primarily consists of a supervised exercise program and educational sessions.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change in physical activity level after pulmonary rehabilitation Tijdsspanne: Baseline measurement and after the program (approx Week 10)	Physical activity is measured using the Actigraph accelerometer, which is a small light weight device clipped onto a waist belt. Its output is vector magnitude units, steps, energy expenditure and activity intensity level. Patients will wearing the device for 5 to 7 days, before and after the program. The pulmonary rehabilitation program consists of 14 sessions, twice a week.	Baseline measurement and after the program (approx Week 10)
Change in level of Self-Efficacy using the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire scores Tijdsspanne: Baseline, and after pulmonary rehabilitation program (approx Week 10)	Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire is a questionnaire measuring the level of self-efficacy. It consists of 15 questions on a 4-point scale. It takes less than 10 minutes to complete.	Baseline, and after pulmonary rehabilitation program (approx Week 10)

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change in 6-Minute Walk Test distance after pulmonary rehabilitation Tijdsspanne: Baseline, and after pulmonary rehabilitation program (approx Week 10)	The 6-Minute Walk Test is a test of functional exercise capacity which is routinely used in pulmonary rehabilitation programs.	Baseline, and after pulmonary rehabilitation program (approx Week 10)
Change in Hospital Anxiety and Depression Scale (HADS) questionnaire score Tijdsspanne: Baseline, and after pulmonary rehabilitation program (approx Week 10)	HADS consists of 14 questions and takes less than 10 minutes to complete. It measures the level of anxiety and depression.	Baseline, and after pulmonary rehabilitation program (approx Week 10)
Change in COPD Assessment Test score Tijdsspanne: Baseline, and after pulmonary rehabilitation program (approx Week 10)	The COPD Assessment Test is an 8-item questionnaire which determines the impact of chronic obstructive pulmonary disease on the patient's wellbeing and daily life. It takes less than 5 minutes to complete.	Baseline, and after pulmonary rehabilitation program (approx Week 10)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University College, London

Medewerkers

Guy's and St Thomas' NHS Foundation Trust

Onderzoekers

Hoofdonderzoeker: Noor Diana Mohamed Sani, University College, London
Studie stoel: Leyla Osman, Dr, University College London, Guy's and St. Thomas' Hospital
Studie directeur: Lynn McDonnell, MSc, Guy's and St Thomas' NHS Foundation Trust

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2014

Primaire voltooiing (Verwacht)

1 augustus 2014

Studie voltooiing (Verwacht)

1 augustus 2014

Studieregistratiedata

Eerst ingediend

11 maart 2014

Eerst ingediend dat voldeed aan de QC-criteria

12 maart 2014

Eerst geplaatst (Schatting)

13 maart 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

29 mei 2014

Laatste update ingediend die voldeed aan QC-criteria

27 mei 2014

Laatst geverifieerd

1 mei 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

5380/001

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .