Long-term Physical Training in Chronic Obstructive Pulmonary Disease

Effects of a Long-term Physical Training Program on Pulmonary and Systemic Aspects in Patients With Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Physical training; Other: Physical training

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabio Pitta, PhD; Phone Number: +55 43 3371-2477; Email: fabiopitta@uol.com.br

Study Locations

• Brazil
  • Parana
    • Londrina, Parana, Brazil, 86038-350
      • Recruiting
      • Hospital Universitário Norte do Paraná (University Hospital Regional North of Parana)
      • Contact: Fabio Pitta, PhD; Phone Number: +55 43 3371-2477; Email: fabiopitta@uol.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-intensity training (LT)	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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity in daily life	Main variable: time spent in physical activities of at least moderate intensity (min/day)	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional exercise capacity	6-minute walking test	Up to 4 years
Maximal exercise capacity	Incremental Shuttle Walking Test	Up to 4 years
Peripheral muscle force	1-repetitium maximum and peak quadriceps torque	Up to 4 years
Respiratory muscle force	Maximal inspiratory and expiratory pressures	Up to 4 years
Body composition	Electrical Bioimpedance	Up to 4 years
Health-related quality of life	Chronic Respiratory Disease Questionnaire (CRDQ)	Up to 4 years
Functional status	London Chest Activity of Daily Living scale (LCADL)	Up to 4 years
Dyspnea sensation	Borg scale	Up to 4 years
Lung function	Post-bronchodilator simple spirometry	Up to 4 years

Collaborators and Investigators

• Sponsor: Universidade Estadual de Londrina
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: February 14, 2012
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Motor activity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: LFIP-001-NAH-1