Long-term Physical Training in Chronic Obstructive Pulmonary Disease

NCT01537627 | Unknown

• 1 other identifier: LFIP-001-NAH-1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Keywords

Motor activity; Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Physical activity in daily life

  Main variable: time spent in physical activities of at least moderate intensity (min/day)

  Up to 4 years

Secondary Outcomes (9)

• Functional exercise capacity

  Up to 4 years

• Maximal exercise capacity

  Up to 4 years

• Peripheral muscle force

  Up to 4 years

• Respiratory muscle force

  Up to 4 years

• Body composition

  Up to 4 years

Study Arms (2)

Low-intensity training (LT)

ACTIVE COMPARATOR

Other: Physical training

High-intensity training (HT)

ACTIVE COMPARATOR

Other: Physical training

Interventions

Physical training 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.

High-intensity training (HT)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

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

Londrina, Paraná, 86038-350, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fabio Pitta, PhD

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

  STUDY CHAIR

• Nidia A. Hernandes, MSc

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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Pitta, PhD

CONTACT

+55 43 3371-2477; fabiopitta@uol.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 23, 2012
• Study Start: November 1, 2009
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

BR (1)