Long-term Physical Training in Chronic Obstructive Pulmonary Disease

Study Overview
=================
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.

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

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Other: Physical training
* Other: Physical training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low-intensity training (LT)<br> | Other: Physical training<br>* 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.<br>|
| Active Comparator: High-intensity training (HT)<br> | Other: Physical training<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motor activity, Exercise, Rehabilitation