Pulmonary Disease, Chronic ObstructiveNCT01537627
Long-term Physical Training in Chronic Obstructive Pulmonary Disease
A study testing Physical training in people with Pulmonary Disease, Chronic Obstructive, run by Universidade Estadual de Londrina at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2009to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being unable to attend the outpatient clinic three times per week
- Inability to understand or cooperate with the assessment methods
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Universitário Norte do Paraná (University Hospital Regional North of Parana)
Londrina, Paraná, 86038-350
Fabio Pitta, PhD, +55 43 3371-2477, fabiopitta@uol.com.br
About this study
Official title: Effects of a Long-term Physical Training Program on Pulmonary and Systemic Aspects in Patients With Chronic Obstructive Pulmonary Disease
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
- Being tested
- Physical training
- Keywords
- Motor activity, Exercise, Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity training (LT) | Active comparator | Not described Receives: Other: Physical training |
| High-intensity training (HT) | Active comparator | Not described Receives: Other: Physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity in daily life
Main variable: time spent in physical activities of at least moderate intensity (min/day)
Measured: Up to 4 years
Secondary outcomes (9)
Functional exercise capacity
6-minute walking test
Measured: Up to 4 years
Maximal exercise capacity
Incremental Shuttle Walking Test
Measured: Up to 4 years
Peripheral muscle force
1-repetitium maximum and peak quadriceps torque
Measured: Up to 4 years
Respiratory muscle force
Maximal inspiratory and expiratory pressures
Measured: Up to 4 years
Body composition
Electrical Bioimpedance
Measured: Up to 4 years
Health-related quality of life
Chronic Respiratory Disease Questionnaire (CRDQ)
Measured: Up to 4 years
Functional status
London Chest Activity of Daily Living scale (LCADL)
Measured: Up to 4 years
Dyspnea sensation
Borg scale
Measured: Up to 4 years
Lung function
Post-bronchodilator simple spirometry
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startNov 2009
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Fabio Pitta, PhD, Universidade Estadual de Londrina
- Investigators
- Fabio Pitta, PhD, Study chair, Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, BrazilNidia A. Hernandes, MSc, Study director, Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, BrazilThaís Sant´Anna, PT, Principal investigator, Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, BrazilKarina C. Furlanetto, PT, Principal investigator, Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, BrazilLeila Donária, PT, Principal investigator, Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537627
- Sponsor's protocol ID
- LFIP-001-NAH-1
- Status last verified
- May 2017
- First submitted
- 14 Feb 2012
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Long-term Physical Training Program on Pulmonary and Systemic Aspects in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01537627
- Acronym / sponsor ID
- LFIP-001-NAH-1
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Motor activity, Exercise, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Nov 2009
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-intensity training (LT) | Active comparator | Other: Physical training |
| High-intensity training (HT) | Active comparator | Other: Physical training |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Being unable to attend the outpatient clinic three times per week
- Inability to understand or cooperate with the assessment methods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical trainingAerobic 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. | Other | High-intensity training (HT) |
| Physical trainingCallisthenic 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. | Other | Low-intensity training (LT) |
Primary outcome
Physical activity in daily life
Time frame: Up to 4 years
Main variable: time spent in physical activities of at least moderate intensity (min/day)
9 secondary outcomes
Functional exercise capacity
Time frame: Up to 4 years
Maximal exercise capacity
Time frame: Up to 4 years
Peripheral muscle force
Time frame: Up to 4 years
Respiratory muscle force
Time frame: Up to 4 years
Body composition
Time frame: Up to 4 years
Health-related quality of life
Time frame: Up to 4 years
Functional status
Time frame: Up to 4 years
Dyspnea sensation
Time frame: Up to 4 years
Lung function
Time frame: Up to 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Pitta, PhD study chair
Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Nidia A. Hernandes, MSc study director
Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
Thaís Sant´Anna, PT principal investigator
Laboratory of Research in Respiratory Physiotherapy, State University of Londrina, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Pulmonary Disease, Chronic Obstructive, run by Universidade Estadual de Londrina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio Pitta, PhD (+55 43 3371-2477, fabiopitta@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity in daily life (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017; AzTrials last refreshed its copy on 30 Oct 2026.