Chronic Obstructive Pulmonary DiseasePhase 4NCT00935181
Respiratory Muscle Stretching in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing respiratory muscle stretching in people with Chronic Obstructive Pulmonary Disease, run by Faculdade Evangelica do Parana at 1 site in Brazil.
Trial summary
Objective: The investigators studied the effects of respiratory muscle stretching in an 8-week pulmonary rehabilitation program. Methods: This was a simple-blind parallel controlled trial, conducted an out-patient clinic. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- respiratory muscle stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Dec 2008
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program
- With a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), in a stable condition (without exacerbations or infections for at least a month)
- Former smokers
Who cannot join
- Patients with a known history of asthma, or severe and/or unstable heart disease
- Any other pathological condition that could impair their physical activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Muscle Stretching in Patients With Chronic Obstructive Pulmonary Disease Submitted a Pulmonary Rehabilitation Program
Objective: The investigators studied the effects of respiratory muscle stretching in an 8-week pulmonary rehabilitation program. Methods: This was a simple-blind parallel controlled trial, conducted an out-patient clinic. Twenty six patients with COPD (mean age 68 ± 6 y, percent of predicted FEV1 47 ± 16) were randomized to either respiratory muscle stretching group plus exercise training (RMS), and exercise training group (Sham), in an 8-week exercise program that had 3 sessions per week. The investigators measured inspiratory and expiratory muscle strength (by maximal inspiratory and expiratory pressure - PIM and PEM), exercise capacity (by 6-minute walk distance), dyspnea and quality of life.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- respiratory muscle stretching
- Keywords
- COPD, diaphragm, muscle, stretching, exercises, dyspnea, respiratory muscle stretching, pulmonary rehabilitation, exercise training, improved exercise capacity, dyspnea, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory muscle stretchingBehavioural
Also called pulmonary rehabilitation
stretching exercises for respiratory muscles like diaphragm, pectoral, dorsalis etc
| Study group | Role | What they receive |
|---|---|---|
| exercise training program | Experimental | The exercise training program consisted of three 90-minute sessions per week for eight weeks. Each session consisted of a stretching exercise, resistance that patients started at 70% of the initial one-repetition maximum (1RM: the maximum load which can be moved only once over the full range of motion without compensatory movements) in the first week (3x8 repetitions). Every week the load was increased by 5% of the 1RM, and endurance training (treadmill walking speed was set at 60% of the average speed obtained from the 6MWT (6MWTpeak) for 10 mins in the first week and was increased to 20 mins in week 8 Receives: Behavioral: respiratory muscle stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle strength
Measured: 2 hours
Secondary outcomes (1)
Exercise capacity
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade Evangelica do Parana
- Sponsor type
- University, hospital or other
- Investigators
- Silvia R. Valderramas, Ph.D, Principal investigator, Faculdade Evangelica do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935181
- Sponsor's protocol ID
- 3145/06
- Status last verified
- Jul 2009
- First submitted
- 29 Jun 2009
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Stretching in Patients With Chronic Obstructive Pulmonary Disease Submitted a Pulmonary Rehabilitation Program
- ClinicalTrials.gov ID
- NCT00935181
- Acronym / sponsor ID
- 3145/06
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, diaphragm, muscle, stretching, exercises, dyspnea, respiratory muscle stretching, pulmonary rehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Faculdade Evangelica do ParanaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Jul 2009 (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.
Objective: The investigators studied the effects of respiratory muscle stretching in an 8-week pulmonary rehabilitation program. Methods: This was a simple-blind parallel controlled trial, conducted an out-patient clinic. Twenty six patients with COPD (mean age 68 ± 6 y, percent of predicted FEV1 47 ± 16) were randomized to either respiratory muscle stretching group plus exercise training (RMS), and exercise training group (Sham), in an 8-week exercise program that had 3 sessions per week. The investigators measured inspiratory and expiratory muscle strength (by maximal inspiratory and expiratory pressure - PIM and PEM), exercise capacity (by 6-minute walk distance), dyspnea and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise training program | Experimental | Behavioral: respiratory muscle stretchingThe exercise training program consisted of three 90-minute sessions per week for eight weeks. Each session consisted of a stretching exercise, resistance that patients started at 70% of the initial one-repetition maximum (1RM: the maximum load which can be moved only once over the full range of motion without compensatory movements) in the first week (3x8 repetitions). Every week the load was increased by 5% of the 1RM, and endurance training (treadmill walking speed was set at 60% of the average speed obtained from the 6MWT (6MWTpeak) for 10 mins in the first week and was increased to 20 mins in week 8 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program
- With a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), in a stable condition (without exacerbations or infections for at least a month)
- Former smokers
Key exclusion criteria (2 listed)
- Patients with a known history of asthma, or severe and/or unstable heart disease
- Any other pathological condition that could impair their physical activities
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 |
|---|---|---|
| respiratory muscle stretchingAlso: pulmonary rehabilitationstretching exercises for respiratory muscles like diaphragm, pectoral, dorsalis etc | Behavioural | exercise training program |
Primary outcome
Inspiratory muscle strength
Time frame: 2 hours
1 secondary outcome
Exercise capacity
Time frame: 2 hours
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 Jul 2009.
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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.
Silvia R. Valderramas, Ph.D principal investigator
Faculdade Evangelica do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing respiratory muscle stretching in people with Chronic Obstructive Pulmonary Disease, run by Faculdade Evangelica do Parana 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 3 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: finished, as of the sponsor's last update on 8 Jul 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Inspiratory muscle strength (time frame: 2 hours). 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 8 Jul 2009.