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

NCT01779960 | Unknown

• 2 other identifiers: LFIP-001-KCF-1483107/2011-5
• Study Type: observational
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

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).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; Motor activity; Climatologic station

Outcome Measures

Primary Outcomes (1)

• Physical activity in daily life

  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.

  January 2013 and July 2013. Participants will be followed for the duration of 6 months.

Secondary Outcomes (3)

• Six minute walking test

  January 2013 and July 2013. Participants will be followed for the duration of 6 months.

• Spirometry

  January 2013 and July 2013. Participants will be followed for the duration of 6 months.

• Chronic Respiratory Disease Questionnaire (CRQ)

  January 2013 and July 2013. Participants will be followed for the duration of 6 months.

Study Arms (2)

Londrina

20 patients with moderate-severe COPD from State University of Londrina, Brazi

Other: Londrina

Leuven

20 patients with moderate-severe COPD from Catholic University of Leuven, Belgium

Other: Leuven

Interventions

Londrina OTHER

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).

Also known as: Climatologic Station

Londrina

Leuven OTHER

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).

Also known as: Climatologic Station

Leuven

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of COPD based on internationally accepted criteria
• Absence of orthopedic comorbidities which could interfere on the performance of the proposed assessments

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead
• KU Leuven: collaborator

Study Sites (2)

University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium

Leuven, Belgium

RECRUITING

University Hospital Londrina , Universidade Estadual de Londrina, Brasil

Londrina, Paraná, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Fabio Pitta, PhD

  Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil

  STUDY CHAIR

• Karina C. Furlanetto, PT

  Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• Thierry Troosters, PhD

  University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium

  STUDY CHAIR

• Heleen Demeyer, PT

  University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium

  STUDY DIRECTOR

• Carlos A. Camillo, MSc

  University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium

  PRINCIPAL INVESTIGATOR

• Miek Hornickx, PT

  University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Pitta, PhD

CONTACT

+55 43 33712477; fabiopitta@uol.com.br

Karina Furlanetto, PT

CONTACT

+55 43 33712477; ka_furlanetto@hotmail.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fabio Pitta

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 11, 2015

Record last verified: 2015-06

Locations

BE (1); BR (1)