NCT03042806

Brief Summary

Patients affected from Chronic Obstructive Pulmonary Disease (COPD) benefit from pulmonary rehabilitation in terms of exercise capacity, symptoms and health-related quality of life whereas the effect on physical activity is still not clear. Some studies have investigated the effect of exercise training on daily physical activity. However, there is considerable variability in study findings, data are discordant and the effect of exercise training on physical activity is unclear. There are probably a number of reasons to account for this. First of all, the choice of the method for evaluating physical activity. Although direct observation, double-labelled water and calorimetry are considered the gold standard for assessing physical activity, they are too time consuming and expensive to be used in large population studies .The Physical Activity (PA) of patients with COPD can be assessed using questionnaires. A variety of questionnaires exist that capture different aspects of physical activity such as amount, type, intensity, symptom experience and limitations in the performance of ''activities of daily life''. Up to now, it still does not exist an instrument that evaluates the physical activity of COPD patients in Italian language that takes in account Italian people' lifestyle. Since this is strongly influenced by the environment, cultural and social conditions in which we live, it is essential to have an instrument specifically tailored for the population under study. Aim of this study is to validate the Maugeri Physical Activity questionnaire (MaPAct) in COPD patients pointing to assess self-perceived physical activity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2019

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

February 2, 2017

Last Update Submit

August 7, 2018

Conditions

Keywords

Physical ActivityQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • Questionnaire validity

    Numeric score

    six months

Secondary Outcomes (1)

  • Questionnaire reliability

    six months

Study Arms (1)

experimental group

OTHER

COPD patients will be asked to fill in the Maugeri Physical Activity Questionnaire (MaPAct) to assess self perceived physical activity.

Behavioral: questionnaire

Interventions

questionnaireBEHAVIORAL

all the COPD patients will be ask to complete the questionnaire

experimental group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD diagnosis in stable state, able to read and to write, that accept to sign informed consent

You may not qualify if:

  • will be excluded all patients that were hospitalized in the 30 days before evaluation, patients with degenerative neuromuscular diseases, subjects with motor disabilities limiting deambulation, subjects with memory or comprehension problems, with dementia, parkinson disease, cognitive impairment, and subject that do not give their consent for the participation to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICS Maugeri

Tradate, Va, 21049, Italy

RECRUITING

Related Publications (5)

  • Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

    PMID: 24127811BACKGROUND
  • Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.

    PMID: 24603844BACKGROUND
  • Cindy Ng LW, Mackney J, Jenkins S, Hill K. Does exercise training change physical activity in people with COPD? A systematic review and meta-analysis. Chron Respir Dis. 2012 Feb;9(1):17-26. doi: 10.1177/1479972311430335. Epub 2011 Dec 22.

    PMID: 22194629BACKGROUND
  • Pitta F, Troosters T, Probst VS, Spruit MA, Decramer M, Gosselink R. Quantifying physical activity in daily life with questionnaires and motion sensors in COPD. Eur Respir J. 2006 May;27(5):1040-55. doi: 10.1183/09031936.06.00064105.

    PMID: 16707399BACKGROUND
  • Dobbels F, de Jong C, Drost E, Elberse J, Feridou C, Jacobs L, Rabinovich R, Frei A, Puhan MA, de Boer WI, van der Molen T, Williams K, Pinnock H, Troosters T, Karlsson N, Kulich K, Rudell K; PROactive consortium; PROactive consortium. The PROactive innovative conceptual framework on physical activity. Eur Respir J. 2014 Nov;44(5):1223-33. doi: 10.1183/09031936.00004814. Epub 2014 Jul 17.

    PMID: 25034563BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Antonio Spanevello, professor

    Insubria University

    STUDY DIRECTOR

Central Study Contacts

Elisabetta Zampogna, MSc

CONTACT

Andrea Zanini, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 3, 2017

Study Start

February 2, 2017

Primary Completion

August 7, 2018

Study Completion

July 2, 2019

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations