Long-term Physical Training in Chronic Obstructive Pulmonary Disease
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical training
Physical training
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Motor activity, Exercise, Rehabilitation
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
Sites / Locations
- Hospital Universitário Norte do Paraná (University Hospital Regional North of Parana)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Low-intensity training (LT)
High-intensity training (HT)
Arm Description
Outcomes
Primary Outcome Measures
Physical activity in daily life
Main variable: time spent in physical activities of at least moderate intensity (min/day)
Secondary Outcome Measures
Functional exercise capacity
6-minute walking test
Maximal exercise capacity
Incremental Shuttle Walking Test
Peripheral muscle force
1-repetitium maximum and peak quadriceps torque
Respiratory muscle force
Maximal inspiratory and expiratory pressures
Body composition
Electrical Bioimpedance
Health-related quality of life
Chronic Respiratory Disease Questionnaire (CRDQ)
Functional status
London Chest Activity of Daily Living scale (LCADL)
Dyspnea sensation
Borg scale
Lung function
Post-bronchodilator simple spirometry
Full Information
NCT ID
NCT01537627
First Posted
February 14, 2012
Last Updated
May 2, 2017
Sponsor
Universidade Estadual de Londrina
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT01537627
Brief Title
Long-term Physical Training in Chronic Obstructive Pulmonary Disease
Official Title
Effects of a Long-term Physical Training Program on Pulmonary and Systemic Aspects in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual de Londrina
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Motor activity, Exercise, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-intensity training (LT)
Arm Type
Active Comparator
Arm Title
High-intensity training (HT)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Physical training
Intervention Description
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
Intervention Name(s)
Physical training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical activity in daily life
Description
Main variable: time spent in physical activities of at least moderate intensity (min/day)
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Functional exercise capacity
Description
6-minute walking test
Time Frame
Up to 4 years
Title
Maximal exercise capacity
Description
Incremental Shuttle Walking Test
Time Frame
Up to 4 years
Title
Peripheral muscle force
Description
1-repetitium maximum and peak quadriceps torque
Time Frame
Up to 4 years
Title
Respiratory muscle force
Description
Maximal inspiratory and expiratory pressures
Time Frame
Up to 4 years
Title
Body composition
Description
Electrical Bioimpedance
Time Frame
Up to 4 years
Title
Health-related quality of life
Description
Chronic Respiratory Disease Questionnaire (CRDQ)
Time Frame
Up to 4 years
Title
Functional status
Description
London Chest Activity of Daily Living scale (LCADL)
Time Frame
Up to 4 years
Title
Dyspnea sensation
Description
Borg scale
Time Frame
Up to 4 years
Title
Lung function
Description
Post-bronchodilator simple spirometry
Time Frame
Up to 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio Pitta, PhD
Phone
+55 43 3371-2477
Email
fabiopitta@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Pitta, PhD
Organizational Affiliation
Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nidia A. Hernandes, MSc
Organizational Affiliation
Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thaís Sant´Anna, PT
Organizational Affiliation
Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karina C. Furlanetto, PT
Organizational Affiliation
Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leila Donária, PT
Organizational Affiliation
Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário Norte do Paraná (University Hospital Regional North of Parana)
City
Londrina
State/Province
Parana
ZIP/Postal Code
86038-350
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Pitta, PhD
Phone
+55 43 3371-2477
Email
fabiopitta@uol.com.br
12. IPD Sharing Statement
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Long-term Physical Training in Chronic Obstructive Pulmonary Disease
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