Clinical trial NCT01537627: Long-term Physical Training in Chronic Obstructive Pulmonary Disease
Official title: Effects of a Long-term Physical Training Program on Pulmonary and Systemic Aspects in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Motor activity
Exercise
Rehabilitation
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2012-02-23
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several impairing factors contribute to physical limitation in chronic obstructive pulmonary disease (COPD) as deconditioning, muscle dysfunction and physical inactivity. The available literature clearly indicates that these therapeutic targets benefit from exercise training in patients with COPD and, currently, the key point is not whether patients should or not exercise, but which is the specific contribution of each exercise modality to this population. About this topic, the characteristics of a physical training program to be offered to patients have been a point discussed among researchers in this field, although recently the high-intensity training has been recognized as superior in comparison to the low-intensity training. Literature also indicates that, in order to change the sedentary lifestyle of patients with COPD, long-term training programs are indicated. However, a doubt still remains: if long-term programs are one of the key points to reduce physical inactivity, it is not yet clear whether it is necessary to include high-intensity exercises in that long-term program. If the duration is the only factor influencing the outcomes of the program, thus the intensity of training could be reduced, increasing the adherence of patients to the protocol. Based on this hypothesis, the aim of this study is to compare the effects of two physical training protocols in a long-term rehabilitation program (6 months) in patients with COPD: a high-intensity protocol (based on endurance and resistive training) and a low-intensity protocol (based on callisthenic and breathing exercises training). It is expected that the results of this study contribute to the scientific literature by demonstrating whether low- and high-intensity training contribute equally to change the sedentary lifestyle of patients after a long-term exercise program.


Eligibility criteria: Inclusion Criteria:

* Chronic obstructive pulmonary disease (COPD) diagnosis according to Global Initiative for Chronic Obstructive Lung Disease(GOLD)criteria
* Clinical stability (i.e. absence of acute exacerbation in the last 3 months)
* Absence of any unstable/severe cardiac,osteoarticular or neuromuscular disorders which could limit physical activities in daily life
* Non participation in pulmonary rehabilitation in the last year

Exclusion Criteria:

* Being unable to attend the outpatient clinic three times per week
* Inability to understand or cooperate with the assessment methods

Primary outcomes:
measure: Physical activity in daily life
timeFrame: Up to 4 years
Secondary outcomes:
measure: Functional exercise capacity
timeFrame: Up to 4 years
measure: Maximal exercise capacity
timeFrame: Up to 4 years
measure: Peripheral muscle force
timeFrame: Up to 4 years
measure: Respiratory muscle force
timeFrame: Up to 4 years
measure: Body composition
timeFrame: Up to 4 years
measure: Health-related quality of life
timeFrame: Up to 4 years
measure: Functional status
timeFrame: Up to 4 years
measure: Dyspnea sensation
timeFrame: Up to 4 years
measure: Lung function
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Hospital Universitário Norte do Paraná (University Hospital Regional North of Parana)
state: Parana
Study officials:
affiliation: Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
name: Fabio Pitta, PhD
role: STUDY_CHAIR
affiliation: Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
name: Nidia A. Hernandes, MSc
role: STUDY_DIRECTOR
affiliation: Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
name: Thaís Sant´Anna, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
name: Karina C. Furlanetto, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
name: Leila Donária, PT
role: PRINCIPAL_INVESTIGATOR
References: