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.
Verified January 2013 by Universidade Estadual de Londrina
Sponsor:
Universidade Estadual de Londrina
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
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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
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:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Disease Attributes Pathologic Processes Respiratory Tract Diseases Lung Diseases, Obstructive |
ClinicalTrials.gov processed this record on May 19, 2013