Long-term Physical Training in Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01537627
• Other study ID #: LFIP-001-NAH-1
• Status: Recruiting
• Phase: N/A
• First received: February 14, 2012
• Last updated: May 2, 2017
• Start date: November 2009
• Est. completion date: July 2018

Study information

• Verified date: May 2017
• Source: Universidade Estadual de Londrina
• Contact: Fabio Pitta, PhD
• Phone: +55 43 3371-2477
• Email: fabiopitta[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Universitário Norte do Paraná (University Hospital Regional North of Parana)	Londrina	Parana

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Estadual de Londrina	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity in daily life	Main variable: time spent in physical activities of at least moderate intensity (min/day)	Up to 4 years
Secondary	Functional exercise capacity	6-minute walking test	Up to 4 years
Secondary	Maximal exercise capacity	Incremental Shuttle Walking Test	Up to 4 years
Secondary	Peripheral muscle force	1-repetitium maximum and peak quadriceps torque	Up to 4 years
Secondary	Respiratory muscle force	Maximal inspiratory and expiratory pressures	Up to 4 years
Secondary	Body composition	Electrical Bioimpedance	Up to 4 years
Secondary	Health-related quality of life	Chronic Respiratory Disease Questionnaire (CRDQ)	Up to 4 years
Secondary	Functional status	London Chest Activity of Daily Living scale (LCADL)	Up to 4 years
Secondary	Dyspnea sensation	Borg scale	Up to 4 years
Secondary	Lung function	Post-bronchodilator simple spirometry	Up to 4 years