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Trial record 2 of 52199 for:    questionnaire

Validation of a Questionnaire for Physical Activity in COPD: Maugeri Physical Activity Questionnaire (MaPAct) (MaPAct)

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ClinicalTrials.gov Identifier: NCT03042806
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Fondazione Salvatore Maugeri
Information provided by (Responsible Party):
Elisabetta Zampogna, Fondazione Salvatore Maugeri

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.


Condition or disease Intervention/treatment Phase
COPD Behavioral: questionnaire Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Validation of a Questionnaire Evaluating the Physical Activities in COPD Patients: the Maugeri Physical Activity Questionnaire - MaPAct
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : August 7, 2018
Estimated Study Completion Date : July 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
experimental group
COPD patients will be asked to fill in the Maugeri Physical Activity Questionnaire (MaPAct) to assess self perceived physical activity.
Behavioral: questionnaire
all the COPD patients will be ask to complete the questionnaire




Primary Outcome Measures :
  1. Questionnaire validity [ Time Frame: six months ]
    Numeric score


Secondary Outcome Measures :
  1. Questionnaire reliability [ Time Frame: six months ]
    Numeric score



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042806


Contacts
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Contact: Elisabetta Zampogna, MSc +390331829599 elisabetta.zampogna@icsmaugeri.it
Contact: Andrea Zanini, MD +390331829222 azanini67@gmail.com

Locations
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Italy
ICS Maugeri Recruiting
Tradate, Va, Italy, 21049
Contact: Elisabetta Zampogna, MSc    +390331829599    elisabetta.zampogna@icsmaugeri.it   
Sponsors and Collaborators
Elisabetta Zampogna
Fondazione Salvatore Maugeri
Investigators
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Study Director: Antonio Spanevello, professor Insubria University

Publications:
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 Mölken 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. Erratum in: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.

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Responsible Party: Elisabetta Zampogna, Principal Investigator, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT03042806     History of Changes
Other Study ID Numbers: ICSMaugeri
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elisabetta Zampogna, Fondazione Salvatore Maugeri:
Physical Activity
Questionnaire