Long-term Physical Training in Chronic Obstructive Pulmonary Disease
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Other: Physical training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of a Long-term Physical Training Program on Pulmonary and Systemic Aspects in Patients With Chronic Obstructive Pulmonary Disease |
- Physical activity in daily life [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Main variable: time spent in physical activities of at least moderate intensity (min/day)
- Functional exercise capacity [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]6-minute walking test
- Maximal exercise capacity [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Incremental Shuttle Walking Test
- Peripheral muscle force [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]1-repetitium maximum and peak quadriceps torque
- Respiratory muscle force [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Maximal inspiratory and expiratory pressures
- Body composition [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Electrical Bioimpedance
- Health-related quality of life [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Chronic Respiratory Disease Questionnaire (CRDQ)
- Functional status [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]London Chest Activity of Daily Living scale (LCADL)
- Dyspnea sensation [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Borg scale
- Lung function [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Post-bronchodilator simple spirometry
| Estimated Enrollment: | 82 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Low-intensity training (LT) |
Other: Physical training
Callisthenic and breathing exercises are performed during 1 hour, 3 times per week during 6 months. The exercises are divided in 7 different sets and the degree of difficulty of the exercises progresses according to the set.
|
| Active Comparator: High-intensity training (HT) |
Other: Physical training
Aerobic exercises (treadmill and cycloergometer): Initially, the intensity is targeted at 60% of maximal capacity and it increases weekly until 110% of maximal capacity. Exercises duration: at least, 20 minutes. Resistive exercises (multi gym station; muscle groups: biceps, triceps and quadriceps): Initially, the intensity is targeted at 70% of one maximum repetition (1RM) and it increases weekly until 121% of 1RM. Exercises duration: 3 sets of 8 repetitions. Both exercise training are performed 3 times per week during 6 months. |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Fabio Pitta, PhD | +55 43 3371-2477 | fabiopitta@uol.com.br |
| Brazil | |
| Hospital Universitário Norte do Paraná (University Hospital Regional North of Parana) | Recruiting |
| Londrina, Parana, Brazil, 86038-350 | |
| Contact: Fabio Pitta, PhD +55 43 3371-2477 fabiopitta@uol.com.br | |
| Study Chair: | Fabio Pitta, PhD | Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil |
| Study Director: | Nidia A. Hernandes, MSc | Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil |
| Principal Investigator: | Thaís Sant´Anna, PT | Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil |
| Principal Investigator: | Karina C. Furlanetto, PT | Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil |
| Principal Investigator: | Leila Donária, PT | Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil |
More Information
No publications provided
| Responsible Party: | Fabio Pitta, PhD, PhD, Universidade Estadual de Londrina |
| ClinicalTrials.gov Identifier: | NCT01537627 History of Changes |
| Other Study ID Numbers: | LFIP-001-NAH-1 |
| Study First Received: | February 14, 2012 |
| Last Updated: | February 23, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Universidade Estadual de Londrina:
|
Motor activity Exercise Rehabilitation |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013