Long-term Physical Training in Chronic Obstructive Pulmonary Disease

NCT ID: NCT01537627

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2018-07-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low-intensity training (LT)

Group Type: ACTIVE_COMPARATOR

Physical training

Intervention Type: OTHER

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.

High-intensity training (HT)

Group Type: ACTIVE_COMPARATOR

Physical training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Universidade Estadual de Londrina

OTHER

Sponsor Role: lead

Responsible Party

Fabio Pitta, PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabio Pitta, PhD

Role: STUDY_CHAIR

Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil

Nidia A. Hernandes, MSc

Role: STUDY_DIRECTOR

Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil

Thaís Sant´Anna, PT

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil

Karina C. Furlanetto, PT

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil

Leila Donária, PT

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil

Locations

Hospital Universitário Norte do Paraná (University Hospital Regional North of Parana)

Londrina, Paraná, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Fabio Pitta, PhD

Role: CONTACT

fabiopitta@uol.com.br

+55 43 3371-2477

Facility Contacts

Fabio Pitta, PhD

Role: primary

fabiopitta@uol.com.br

+55 43 3371-2477

Other Identifiers

LFIP-001-NAH-1

Identifier Type: -

Identifier Source: org_study_id