Diabetes MellitusPhase 4NCT00752440
Inspiratory Muscle Training in Patients With Autonomic Neuropathic
A Phase 4 study testing Inspiratory muscle training (IMT) in people with Diabetes Mellitus and Diabetic Autonomic Neuropathy, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
This study describes a controlled randomized clinical trial to evaluate the effect of inspiratory muscle training in patients with diabetic autonomic neuropathy. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Diabetic Autonomic Neuropathy
- What is being tested?
- Inspiratory muscle training (IMT)
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2006to Jul 2009
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic autonomic neuropathy
- Age between 36 and
- 70 years old and signed in informed consent form
Who cannot join
- Presence of congestive heart failure
- Chronic obstructive pulmonary disease (FEV1 < 70% and/or FEV1%< 80
- Class II or III obesity (body mass index > 35)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Institudo de Cardiologia do Rio Grande do Sul
Porto Alegre, RGS
Beatriz D Schann, MD, ScD, 555132303600 ext. 3757, beatrizschann@gmail.com
About this study
Official title: Inspiratory Muscle Training in Patients With Autonomic Neuropathic: a Randomized Trial
This study describes a controlled randomized clinical trial to evaluate the effect of inspiratory muscle training in patients with diabetic autonomic neuropathy.
Read the detailed description
The diabetic autonomic neuropathy (NAD) is a common complication of diabetes mellitus (DM), both of the type 1 diabetes mellitus (DM1) as of the type 2 diabetes mellitus (DM2). The results of this study, would help to reveal the degree of commitment generated by NAD in respiratory muscle strength, can also enable the development of a new therapeutic approach, such non-pharmacological (respiratory muscle training), with a view to improve the respiratory muscle strength and alleviate the autonomic dysfunction in these patients.
- Conditions
- Diabetes Mellitus, Diabetic Autonomic Neuropathy
- Being tested
- Inspiratory muscle training (IMT)
- Keywords
- Diabetes Mellitus, Autonomic Neuropathy, Inspiratory Muscle training
- Medical subject headings
- Diabetes Mellitus, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training (IMT)Other
Also called Diabetic autonomic neuropathy;, Inspiratory muscle function testing;, forced vital capacity and forced expiratory volume;, Maximal functional capacity with incremental exercise test;
IMT (30 min 7 times per week, for 8 weeks)
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle strength
Measured: eight
Secondary outcomes (1)
Variability of heart rate
Measured: eight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startAug 2006
- Primary completionNov 2008 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Investigators
- Beatriz D Schann, MD, ScD, Principal investigator, Institudo de cardiologia de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752440
- Sponsor's protocol ID
- 3865/06
- Status last verified
- Sep 2008
- First submitted
- 12 Sep 2008
- Last updated
- 16 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training in Patients With Autonomic Neuropathic: a Randomized Trial
- ClinicalTrials.gov ID
- NCT00752440
- Acronym / sponsor ID
- 3865/06
- Conditions
- Diabetes Mellitus, Diabetic Autonomic Neuropathy
- Keywords
- Diabetes Mellitus, Autonomic Neuropathy, Inspiratory Muscle training
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 15 Sep 2008 (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.
This study describes a controlled randomized clinical trial to evaluate the effect of inspiratory muscle training in patients with diabetic autonomic neuropathy.
Detailed description
The diabetic autonomic neuropathy (NAD) is a common complication of diabetes mellitus (DM), both of the type 1 diabetes mellitus (DM1) as of the type 2 diabetes mellitus (DM2). The results of this study, would help to reveal the degree of commitment generated by NAD in respiratory muscle strength, can also enable the development of a new therapeutic approach, such non-pharmacological (respiratory muscle training), with a view to improve the respiratory muscle strength and alleviate the autonomic dysfunction in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetic autonomic neuropathy
- Age between 36 and
- 70 years old and signed in informed consent form
Key exclusion criteria (3 listed)
- Presence of congestive heart failure
- Chronic obstructive pulmonary disease (FEV1 < 70% and/or FEV1%< 80
- Class II or III obesity (body mass index > 35)
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 |
|---|---|---|
| Inspiratory muscle training (IMT)Also: Diabetic autonomic neuropathy;, Inspiratory muscle function testing;, forced vital capacity and forced expiratory volume;, Maximal functional capacity with incremental exercise test;IMT (30 min 7 times per week, for 8 weeks) | Other | – |
Primary outcome
Inspiratory muscle strength
Time frame: eight
1 secondary outcome
Variability of heart rate
Time frame: eight
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2008.
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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.
Beatriz D Schann, MD, ScD principal investigator
Institudo de cardiologia de Porto Alegre
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 Inspiratory muscle training (IMT) in people with Diabetes Mellitus and Diabetic Autonomic Neuropathy, run by Instituto de Cardiologia do Rio Grande do Sul 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 3 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 16 Sep 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatriz D Schaan, MD, ScD (555132303600 ext. 3757, beatrizschann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory muscle strength (time frame: eight). 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 16 Sep 2008.