Long-term Physical Training in Chronic Obstructive Pulmonary Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Universidade Estadual de Londrina.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Fabio Pitta, PhD, Universidade Estadual de Londrina
ClinicalTrials.gov Identifier:
NCT01537627
First received: February 14, 2012
Last updated: February 23, 2012
Last verified: February 2012
  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

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: Up to 4 years ] [ Designated as safety issue: No ]
    Main variable: time spent in physical activities of at least moderate intensity (min/day)


Secondary Outcome Measures:
  • 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
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
  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: NCT01537627

Contacts
Contact: Fabio Pitta, PhD +55 43 3371-2477 fabiopitta@uol.com.br

Locations
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   
Sponsors and Collaborators
Universidade Estadual de Londrina
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014