DyspneaPhase 2/3NCT02036762
STRETCH OF RESPIRATORY MUSCLES IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
A Phase 2/3 study testing Stretching Exercises in people with Dyspnea and Quality of Life, run by University of Sao Paulo at 3 sites in Brazil.
Trial summary
THE AIM OF THIS STUDY IS TO TEST IF THE STRETCHING OF THE RESPIRATORY ACCESSORY MUSCLE PROVIDE SOME BENEFIT ON THORACOABDOMINAL MECHANICS, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Dyspnea, Quality of Life, Respiratory Symptoms
- What is being tested?
- Stretching Exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesBrazil
- Study dates
- Nov 2011to Jan 2014
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Obstructive Pulmonary Disease Diagnosis
- Clinical stability
- Absence of previous thoracic surgery
- Absence of other limitations
Who cannot join
- Copd exacerbation
- Absence greater than three days
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Physiotherapy Departament of University of São Paulo
São Paulo, São Paulo, 05360-000
FOFITO
São Paulo, São Paulo, 05360000
Hospital das Clinicas
São Paulo, São Paulo
About this study
Official title: EFFECTS OF RESPIRATORY MUSCLE STRETCH ON THORACOABDOMINAL MECHANIC, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
THE AIM OF THIS STUDY IS TO TEST IF THE STRETCHING OF THE RESPIRATORY ACCESSORY MUSCLE PROVIDE SOME BENEFIT ON THORACOABDOMINAL MECHANICS, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Read the detailed description
PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE WILL BE SUBMITTED TO PASSIVE STRETCHING OF RESPIRATORY MUSCLES AND EXERCISE IN TREADMILL DURING 12 WEEKS, TWICE A WEEK. ONE WEEK AFTER THE TRAINING PERIOD, THE FUNCTIONAL CAPACITY, THE THORACOABDOMINAL MECHANICS AND LEVELS OF ANXIETY AND DEPRESSION WILL BE ASSESSED.
- Conditions
- Dyspnea, Quality of Life, Respiratory Symptoms
- Being tested
- Stretching Exercises
- Keywords
- Chronic Obstructive Pulmonary Disease, Thoracoabdominal Mechanics, Functional capacity, Quality of life
- Medical subject headings
- Dyspnea, Signs and Symptoms, Respiratory, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching ExercisesOther
The group submitted to stretching exercises in the respiratory muscles and treadmill exercises
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | The group submitted to stretching exercises in the respiratory muscles and treadmill exercises Receives: Other: Stretching Exercises |
| Control Group | Sham comparator | The control group received stretching exercises in the fist and ankle muscles and treadmill exercises Receives: Other: Stretching Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Distance obtained (in meters) during six minutes walking test
Measured: One week after the end of training
Secondary outcomes (1)
Thoracoabdominal mechanics
The kinematic will be analyzed by optoelectronic plethysmograph during 30 seconds at rest, followed by 30 seconds after 3 minutes cycling without load, followed by 30 seconds after 30 minutes pedaling with load (25% of the calculated maximum watt).
Measured: One week after the end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startNov 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliano Wada, University of Sao Paulo
- Investigators
- Celso Carvalho, Dr., Study director, Physiotherapy Departament of University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036762
- Sponsor's protocol ID
- HCFMUSP 1295/09
- Status last verified
- Jan 2014
- First submitted
- 15 Aug 2013
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF RESPIRATORY MUSCLE STRETCH ON THORACOABDOMINAL MECHANIC, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
- ClinicalTrials.gov ID
- NCT02036762
- Acronym / sponsor ID
- HCFMUSP 1295/09
- Conditions
- Dyspnea, Quality of Life, Respiratory Symptoms
- Keywords
- Chronic Obstructive Pulmonary Disease, Thoracoabdominal Mechanics, Functional capacity, Quality of life
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Jan 2014 (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 AIM OF THIS STUDY IS TO TEST IF THE STRETCHING OF THE RESPIRATORY ACCESSORY MUSCLE PROVIDE SOME BENEFIT ON THORACOABDOMINAL MECHANICS, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Detailed description
PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE WILL BE SUBMITTED TO PASSIVE STRETCHING OF RESPIRATORY MUSCLES AND EXERCISE IN TREADMILL DURING 12 WEEKS, TWICE A WEEK. ONE WEEK AFTER THE TRAINING PERIOD, THE FUNCTIONAL CAPACITY, THE THORACOABDOMINAL MECHANICS AND LEVELS OF ANXIETY AND DEPRESSION WILL BE ASSESSED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Other: Stretching ExercisesThe group submitted to stretching exercises in the respiratory muscles and treadmill exercises |
| Control Group | Sham comparator | Other: Stretching ExercisesThe control group received stretching exercises in the fist and ankle muscles and treadmill exercises |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic Obstructive Pulmonary Disease Diagnosis
- Clinical stability
- Absence of previous thoracic surgery
- Absence of other limitations
Key exclusion criteria (2 listed)
- Copd exacerbation
- Absence greater than three 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 |
|---|---|---|
| Stretching ExercisesThe group submitted to stretching exercises in the respiratory muscles and treadmill exercises | Other | Control Group, Treatment Group |
Primary outcome
Functional Capacity
Time frame: One week after the end of training
Distance obtained (in meters) during six minutes walking test
1 secondary outcome
Thoracoabdominal mechanics
Time frame: One week after the end of training
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 15 Jan 2014.
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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.
Celso Carvalho, Dr. study director
Physiotherapy Departament of University of São Paulo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Stretching Exercises in people with Dyspnea and Quality of Life, run by University of Sao Paulo at 3 sites 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: finished, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Functional Capacity (time frame: One week after the end of training). 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 15 Jan 2014.