Diabetes ComplicationsNCT00815178
Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness
A study testing Inspiratory muscle training in people with Diabetes Complications and Inspiratory Muscle Weakness, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of the study is to determine if inspiratory muscle training improves inspiratory muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Complications, Inspiratory Muscle Weakness
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2006to Sep 2008
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes melittus
- sedentary
- inspiratory muscle weakness with PImax < 70% of the predicted
Who cannot join
- mass index > 33 kg/m2
- exercise-induced asthma history
- infectious disease
- osteoarticular disease
- regular alcohol or tobacco consumption in the past 6 months
- cardiac disease
- pulmonary disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness: A Randomized, Controlled Clinical Trial
The purpose of the study is to determine if inspiratory muscle training improves inspiratory muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness.
Read the detailed description
In congestive heart failure patients, inspiratory muscle weakness can be reversed by developing diaphragmatic hypertrophy through inspiratory muscle training, improving functional capacity and quality of life. In type 2 diabetes mellitus patients the frequency of inspiratory muscle weakness is unknown, as well as the response to inspiratory muscle training. For this reason, the present study evaluated the inspiratory muscle strength in type 2 diabetes mellitus patients and the effect of inspiratory muscle training on inspiratory muscle strength, pulmonary function, functional capacity and autonomic modulation assessed through heart rate variability.
- Being tested
- Inspiratory muscle training, Inpiratory muscle training placebo
- Keywords
- inspiratory muscle weakness, autonomic modulation, diabetes mellitus, heart rate variability, functional capacity
- Medical subject headings
- Diabetes Complications, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingBehavioural
For Inspiratory muscle training (IMT)patients carried out the IMT on a daily basis for eight weeks, with duration of 30 minutes and intensity corresponding to 30% of resting PImax, with a linear pressure resistance device (Threshold®). Weekly maximum inspiratory pressure (PImax) evaluations and workload adjustments were performed. Inspiratory load was adjusted on a weekly basis to maintain 30% of the subject's PImax. Training sessions were carried out at home for both groups and supervised once a week at the hospital.
Inpiratory muscle training placeboBehavioural
Inspiratory muscle training was carried out on the same basis as in the intervention group but with no inspiratory load.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training | Experimental | Not described Receives: Behavioral: Inspiratory muscle training |
| Placebo | Placebo comparator | Not described Receives: Behavioral: Inpiratory muscle training placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inspiratory pressure
Measured: 8 weeks
Secondary outcomes (3)
Peak exercise oxigen consumption
Measured: 8 weeks
pulmonary function
Measured: 8 weeks
autonomic modulation assessed by heart rate variability
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815178
- Sponsor's protocol ID
- Inspiratory training diabetes
- Status last verified
- Dec 2008
- First submitted
- 26 Dec 2008
- Last updated
- 29 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.
PubMed 18436118Correa AP, Ribeiro JP, Balzan FM, Mundstock L, Ferlin EL, Moraes RS. Inspiratory muscle training in type 2 diabetes with inspiratory muscle weakness. Med Sci Sports Exerc. 2011 Jul;43(7):1135-41. doi: 10.1249/MSS.0b013e31820a7c12.
PubMed 21200342
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness: A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00815178
- Acronym / sponsor ID
- Inspiratory training diabetes
- Keywords
- inspiratory muscle weakness, autonomic modulation, diabetes mellitus, heart rate variability, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 29 Dec 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.
The purpose of the study is to determine if inspiratory muscle training improves inspiratory muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness.
Detailed description
In congestive heart failure patients, inspiratory muscle weakness can be reversed by developing diaphragmatic hypertrophy through inspiratory muscle training, improving functional capacity and quality of life. In type 2 diabetes mellitus patients the frequency of inspiratory muscle weakness is unknown, as well as the response to inspiratory muscle training. For this reason, the present study evaluated the inspiratory muscle strength in type 2 diabetes mellitus patients and the effect of inspiratory muscle training on inspiratory muscle strength, pulmonary function, functional capacity and autonomic modulation assessed through heart rate variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training | Experimental | Behavioral: Inspiratory muscle training |
| Placebo | Placebo comparator | Behavioral: Inpiratory muscle training placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabetes melittus
- sedentary
- inspiratory muscle weakness with PImax < 70% of the predicted
Key exclusion criteria (7 listed)
- mass index > 33 kg/m2
- exercise-induced asthma history
- infectious disease
- osteoarticular disease
- regular alcohol or tobacco consumption in the past 6 months
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 trainingFor Inspiratory muscle training (IMT)patients carried out the IMT on a daily basis for eight weeks, with duration of 30 minutes and intensity corresponding to 30% of resting PImax, with a linear pressure resistance device (Threshold®). Weekly maximum inspiratory pressure (PImax) evaluations and workload adjustments were performed. Inspiratory load was adjusted on a weekly basis to maintain 30% of the subject's PImax. Training sessions were carried out at home for both groups and supervised once a week at the hospital. | Behavioural | Inspiratory muscle training |
| Inpiratory muscle training placeboInspiratory muscle training was carried out on the same basis as in the intervention group but with no inspiratory load. | Behavioural | Placebo |
Primary outcome
Maximum inspiratory pressure
Time frame: 8 weeks
3 secondary outcomes
Peak exercise oxigen consumption
Time frame: 8 weeks
pulmonary function
Time frame: 8 weeks
autonomic modulation assessed by heart rate variability
Time frame: 8 weeks
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 29 Dec 2008.
- Background: PubMed 18436118Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.
- Derived from this study: PubMed 21200342Correa AP, Ribeiro JP, Balzan FM, Mundstock L, Ferlin EL, Moraes RS. Inspiratory muscle training in type 2 diabetes with inspiratory muscle weakness. Med Sci Sports Exerc. 2011 Jul;43(7):1135-41. doi: 10.1249/MSS.0b013e31820a7c12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Diabetes Complications and Inspiratory Muscle Weakness, run by Hospital de Clinicas de Porto Alegre 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 7 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 29 Dec 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. 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.
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?
Maximum inspiratory pressure (time frame: 8 weeks). 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 NCT00815178, which also lists 2 linked publications.
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 29 Dec 2008; AzTrials last refreshed its copy on 8 Nov 2026.