Summer-Winter Variability in the Level of Physical Activity in Daily Life in Brazilian and Belgian Patients With COPD

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Universidade Estadual de Londrina
Sponsor:
Collaborator:
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Fabio Pitta, PhD, Universidade Estadual de Londrina
ClinicalTrials.gov Identifier:
NCT01779960
First received: January 28, 2013
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

Up to this moment, the majority of studies assessing the level of physical activity in daily life in patients with COPD are limited to a cross-sectional design, which does not take into account natural variation of physical activity in daily life due to differences in climatic conditions faced throughout the year. Preliminary evidences suggest that patients with COPD have different physical activity levels according to the seasons of the year. However, the limited current evidences do not allow us to know the magnitude of differences in the level of daily physical activity in patients with COPD when taking into account climatic changes resulting from different seasons of the year in cities and countries with contrasting climatic conditions. This gap observed in the literature does not allow us at this moment to know whether we should or not consider the season of the year as one of the main causes of variability while assessing physical activity in daily life in patients with COPD.

The present project proposes to investigate the hypothesis that patients with COPD who live in a place with less marked decrease in temperature between summer and winter (Londrina, Brazil) have less variability in the level of physical activity in daily life through the year in comparison to patients who live in a place with more marked climatic variability during these seasons (Leuven, Belgium).


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Other: Londrina
Other: Leuven

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Understanding in Depth the Physical Inactivity of Patients With COPD: Comparison of the Summer-Winter Variability in the Level of Physical Activity in Daily Life in Brazilian and Belgian Patients

Resource links provided by NLM:


Further study details as provided by Universidade Estadual de Londrina:

Primary Outcome Measures:
  • Physical activity in daily life [ Time Frame: January 2013 and July 2013. Participants will be followed for the duration of 6 months. ] [ Designated as safety issue: No ]
    Two activity monitors (the SenseWear armband and the Fitbit) will be simultaneously worn during 7 consecutive days. The SenseWear armband (BodyMedia, Pittsburg, PA, USA) is a multisensor composed by a biaxial accelerometer and physiologic sensors. It is a small (8.8 x 5.6 x 2 cm) and lightweight (82g) monitor that was already validated for energy expenditure estimation in patients with COPD. The Fitbit (Fitbit, Inc., San Francisco, CA, USA) is a recently released triaxial accelerometer that is smaller (3.6 x 2.9 x 1 cm) and more lightweight (8g) than the SenseWear. This device provides the number of steps, the distance walked and the energy expenditure in calories, among other variables. In the 7 days of assessment, the patient will remain with the device during 24 hours/day. The patients will be strictly instructed to avoid changing their daily physical activity habits during the monitoring period.


Secondary Outcome Measures:
  • Six minute walking test [ Time Frame: January 2013 and July 2013. Participants will be followed for the duration of 6 months. ] [ Designated as safety issue: No ]
    Two tests will be performed with 30 minutes of interval, according to international standards. Subjects will be encouraged to walk during 6 minutes as fast as possible in a straight leveled 30-meter corridor. Reference values will be those by Troosters et al.

  • Spirometry [ Time Frame: January 2013 and July 2013. Participants will be followed for the duration of 6 months. ] [ Designated as safety issue: No ]
    Pulmonary function test (post-bronchodilator spirometry) measuring slow vital capacity (SVC), forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and FEV1/FVC ratio will be performed by the use of a hand-held spirometer (Spiropalm, Cosmed, Italy), following the American Thoracic Society - European Respiratory Society (ATS-ERS) standardized protocol [14] and based on the reference values by Pereira et al. for Brazilian patients and Knudson et al. for European patients.

  • Chronic Respiratory Disease Questionnaire (CRQ) [ Time Frame: January 2013 and July 2013. Participants will be followed for the duration of 6 months. ] [ Designated as safety issue: No ]
    The CRQ contains 20 questions divided in 4 domains: dyspnea (5 questions), fatigue (4 questions), emotional function (7 questions) and self control (4 questions). The dyspnea domain is individualized, which means that each patient selects from a list the activities which induce dyspnea in the last two weeks, and they can report other activities that are not on the list. Subsequently, among the reported and selected activities, the patient chooses 5 activities considered the most important ones and by the use of a scale of 7 points the patient grades how much dyspnea interferes on these activities. In this scale the score ranges from 1 (maximum impairment) to 7 (no impairment at all). Concerning the other domains (fatigue, emotional function and self control), the questions are standardized and the patient answers each question using the scale of 7 points. The results are presented on average score of each domain, and the higher the score, the better the subject quality of life.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Londrina
20 patients with moderate-severe COPD from State University of Londrina, Brazi
Other: Londrina
Two groups of patients, one group in Londrina and another group in Leuven, will be simultaneously and objectively evaluated concerning their physical activity in daily life during one week in two different moments: in January 2013 (winter in Leuven and summer in Londrina), and then the same two groups of patients will be once again simultaneously re-evaluated during another week in July 2013 (summer in Leuven and winter in Londrina).
Other Name: Climatologic Station
Leuven
20 patients with moderate-severe COPD from Catholic University of Leuven, Belgium
Other: Leuven
Two groups of patients, one group in Londrina and another group in Leuven, will be simultaneously and objectively evaluated concerning their physical activity in daily life during one week in two different moments: in January 2013 (winter in Leuven and summer in Londrina), and then the same two groups of patients will be once again simultaneously re-evaluated during another week in July 2013 (summer in Leuven and winter in Londrina).
Other Name: Climatologic Station

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The sample will be composed by at least 35 patients with moderate-severe COPD from each institution involved (Catholic University of Leuven, Belgium and State University of Londrina, Brazil), adding up to 70 patients. However, the sample size could be increased if necessary to achieve intermediate calculation of the sample power performed during the study. Both groups should be similar concerning anthropometric characteristics, gender distribution and severity feature of the disease (especially FEV1). Therefore, an eventual increase in the final number of patients may also be necessary in case this similarity is not achieved in the final data collection of the planned sample.

Criteria

Inclusion Criteria:

  • Diagnosis of COPD based on internationally accepted criteria
  • Clinical stability (absence of exacerbations) for at least 3 months before inclusion in the study
  • Absence of orthopedic comorbidities which could interfere on the performance of the proposed assessments

Exclusion Criteria:

  • Patients will be excluded of the study if they do not demonstrate physical or cognitive conditions to complete the proposed assessments,
  • If they suffer from a moderate or severe acute exacerbation in the period between the two assessment points
  • If they decide to leave the study for any reason
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779960

Contacts
Contact: Fabio Pitta, PhD +55 43 33712477 fabiopitta@uol.com.br
Contact: Karina Furlanetto, PT +55 43 33712477 ka_furlanetto@hotmail.com

Locations
Belgium
University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium Recruiting
Leuven, Belgium
Contact: Thierry Troosters, PhD       Thierry.Troosters@med.kuleuven.be   
Contact: Carlos A. Camillo, MSc       carlosaugustocamillo@yahoo.com.br   
Sub-Investigator: Heleen Demeyer         
Principal Investigator: Thierry Troosters, PhD         
Sub-Investigator: Carlos A. Camillo, MSc         
Sub-Investigator: Miek Hornickx, PT         
Brazil
University Hospital Londrina , Universidade Estadual de Londrina, Brasil Recruiting
Londrina, Paraná, Brazil
Contact: Fabio Pitta, PhD    +55 43 33712477    fabiopitta@uol.com.br   
Contact: Karina Furlanetto, PT    +55 43 33712477    ka_furlanetto@hotmail.com   
Principal Investigator: Fabio Pitta, PhD         
Sub-Investigator: Karina C. Furlanetto         
Sub-Investigator: Nidia A. Hernandes, PhD         
Sub-Investigator: Thais Sant`Anna, MSc         
Sub-Investigator: Vanessa S. Probst, PhD         
Sponsors and Collaborators
Universidade Estadual de Londrina
Katholieke Universiteit Leuven
Investigators
Study Chair: Fabio Pitta, PhD Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Study Director: Karina C. Furlanetto, PT Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Principal Investigator: Nidia A. Hernandes, PhD Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Principal Investigator: Thais Sant`Anna, MSc Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Principal Investigator: Vanessa S. Probst, PhD Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Study Chair: Thierry Troosters, PhD University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium
Study Director: Heleen Demeyer, PT University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium
Principal Investigator: Carlos A. Camillo, MSc University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium
Principal Investigator: Miek Hornickx, PT University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium
  More Information

No publications provided

Responsible Party: Fabio Pitta, PhD, Fabio Pitta, Universidade Estadual de Londrina
ClinicalTrials.gov Identifier: NCT01779960     History of Changes
Other Study ID Numbers: LFIP-001-KCF-1, 483107/2011-5
Study First Received: January 28, 2013
Last Updated: January 30, 2013
Health Authority: Brazil: National Committee of Ethics in Research
Belgium: Ethics Committee

Keywords provided by Universidade Estadual de Londrina:
Pulmonary Disease, Chronic Obstructive
Motor activity
Climatologic station

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on September 22, 2014