Chronic Obstructive Pulmonary DiseaseRECOPDNCT01786928
The Role of Resistance Exercise in Chronic Obstructive Pulmonary Disease Exacerbation
A study testing Resistance training in people with Chronic Obstructive Pulmonary Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether resistance exercise are effective in combating the decline in muscle strength during an exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2009to Oct 2010
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients hospitalized for exacerbation of COPD
Who cannot join
- patients presenting change in mental status (confusion, lethargy or coma)
- persistence or worsening in hypoxemia (PaO2<40mmHg) and/or respiratory acidosis (pH<7.25) despite oxygen supplementation or use of non-invasive ventilation
- hemodynamic instability requiring vasoactive drugs
- patients transferred to ICU
- hospitalization lower than 5 days
- diseases that prevented the exercises
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Resistance Training During Hospitalization in COPD Patients: a Randomized and Controlled Trial
The purpose of this study is to determine whether resistance exercise are effective in combating the decline in muscle strength during an exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
Read the detailed description
Acute exacerbations are common in patients with COPD and cause specific signs and symptoms, such as increased dyspnea, productive cough with altered sputum, and fever. With disease progression, exacerbations are frequent and have a negative impact on health related quality of life and pulmonary function as well as increase mortality. More severe exacerbations require hospitalization resulting in enormous health expenditures, severely reducing daily life activities and declining peripheral muscle strength that can be only partially reversed after 3 months. Despite many features have been pointed out as responsible for the decrease in muscle strength during hospitalization, physical inactivity seems the most important.
Resistance training is an interesting therapeutic option to prevent and/or reverse muscular dysfunction due to immobilised in healthy subjects and stable COPD patients because induces hypertrophy of type II fibers, increases muscle strength and exercise tolerance. In addition, provokes lower dyspnea perception during effort compared with other exercise training. Despite these benefits for stable COPD, the impact of a resistance exercise program during hospitalization remains poorly known.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Resistance training
- Keywords
- chronic obstructive pulmonary disease, exacerbation, resistance training, muscle force
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Resistance training group received training program for upper (shoulder flexion and abduction and biceps) and lower limbs (knee extension and flexion and hip flexion). Daily exercise for every muscle was performed with free weights at 80% of an maximal repetition test and a 4 minutes rest was allowed between each step.
| Study group | Role | What they receive |
|---|---|---|
| resistance training | Experimental | resistance training of the upper and lower limbs, two series of 80% of repetition maximum test Receives: Other: Resistance training |
| Control | No intervention | Traditional Respiratory Therapy for bronchial hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization
The metric used to evaluate the strength gain is given in kilogram (absolute value) and percentage relative to that obtained on the second hospital day
Measured: Will be evaluated on the second day of hospitalization, the day of hospital discharge (this time interval must be longer than five days)
Secondary outcomes (1)
The benefits of resistance training during exacerbation of COPD on physical activity in daily life
The metric used to evaluate the changes will be given in minutes and percentage of total time
Measured: Will be evaluated in the third and fifth day of hospitalization and thirty days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Celso Ricardo Fernandes de Carvalho, University of Sao Paulo
- Investigators
- Rodrigo C Borges, specialist, Study chair, school of Medicine university of sao paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786928
- Sponsor's protocol ID
- PTR-001-RCB
- Acronym
- RECOPD
- Status last verified
- Feb 2013
- First submitted
- 10 Jan 2012
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Borges RC, Carvalho CR. Impact of resistance training in chronic obstructive pulmonary disease patients during periods of acute exacerbation. Arch Phys Med Rehabil. 2014 Sep;95(9):1638-45. doi: 10.1016/j.apmr.2014.05.007. Epub 2014 May 28.
PubMed 24879965
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Resistance Training During Hospitalization in COPD Patients: a Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT01786928
- Acronym / sponsor ID
- RECOPD / PTR-001-RCB
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, exacerbation, resistance training, muscle force
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Feb 2013 (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.
The purpose of this study is to determine whether resistance exercise are effective in combating the decline in muscle strength during an exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
Acute exacerbations are common in patients with COPD and cause specific signs and symptoms, such as increased dyspnea, productive cough with altered sputum, and fever. With disease progression, exacerbations are frequent and have a negative impact on health related quality of life and pulmonary function as well as increase mortality. More severe exacerbations require hospitalization resulting in enormous health expenditures, severely reducing daily life activities and declining peripheral muscle strength that can be only partially reversed after 3 months. Despite many features have been pointed out as responsible for the decrease in muscle strength during hospitalization, physical inactivity seems the most important.
Resistance training is an interesting therapeutic option to prevent and/or reverse muscular dysfunction due to immobilised in healthy subjects and stable COPD patients because induces hypertrophy of type II fibers, increases muscle strength and exercise tolerance. In addition, provokes lower dyspnea perception during effort compared with other exercise training. Despite these benefits for stable COPD, the impact of a resistance exercise program during hospitalization remains poorly known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resistance training | Experimental | Other: Resistance trainingresistance training of the upper and lower limbs, two series of 80% of repetition maximum test |
| Control | No intervention | –Traditional Respiratory Therapy for bronchial hygiene |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients hospitalized for exacerbation of COPD
Key exclusion criteria (6 listed)
- patients presenting change in mental status (confusion, lethargy or coma)
- persistence or worsening in hypoxemia (PaO2<40mmHg) and/or respiratory acidosis (pH<7.25) despite oxygen supplementation or use of non-invasive ventilation
- hemodynamic instability requiring vasoactive drugs
- patients transferred to ICU
- hospitalization lower than 5 days
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 |
|---|---|---|
| Resistance trainingResistance training group received training program for upper (shoulder flexion and abduction and biceps) and lower limbs (knee extension and flexion and hip flexion). Daily exercise for every muscle was performed with free weights at 80% of an maximal repetition test and a 4 minutes rest was allowed between each step. | Other | resistance training |
Primary outcome
The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization
Time frame: Will be evaluated on the second day of hospitalization, the day of hospital discharge (this time interval must be longer than five days)
The metric used to evaluate the strength gain is given in kilogram (absolute value) and percentage relative to that obtained on the second hospital day
1 secondary outcome
The benefits of resistance training during exacerbation of COPD on physical activity in daily life
Time frame: Will be evaluated in the third and fifth day of hospitalization and thirty days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
- Derived from this study: PubMed 24879965Borges RC, Carvalho CR. Impact of resistance training in chronic obstructive pulmonary disease patients during periods of acute exacerbation. Arch Phys Med Rehabil. 2014 Sep;95(9):1638-45. doi: 10.1016/j.apmr.2014.05.007. Epub 2014 May 28.
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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.
Rodrigo C Borges, specialist study chair
school of Medicine university of sao paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Chronic Obstructive Pulmonary Disease, run by University of Sao Paulo 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 8 Feb 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization (time frame: Will be evaluated on the second day of hospitalization, the day of hospital discharge (this time interval must be longer than five days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01786928, which also lists 1 linked publication.
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 8 Feb 2013.