In Brazil, Which Has an Increasing Number of Elderly People.Phase 2/3NCT01001156
Effects of the Breathing Muscular Training of Institutionalized Elderly
A Phase 2/3 study testing Comparison of different breathing muscular training in people with In Brazil, Which Has an Increasing Number of Elderly People. and The Physiological Alterations of Aging Are Systemic., run by Universidade Camilo Castelo Branco at 1 site in Brazil.
Trial summary
The purpose of this study was to use associated breathing exercises the incentive inspiratory of load lineal pressoric, Threshold® IMT, or of load pressoric alinear, Voldyne®, in institutionalized elderly, comparing the effect of the same ones in the training of the breathing musculature, for the increment of the… Read more about this study
- Who is it for?
- Ages 60 to 82 years
- Conditions the study is for
- In Brazil, Which Has an Increasing Number of Elderly People., The Physiological Alterations of Aging Are Systemic.
- What is being tested?
- Comparison of different breathing muscular training
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2008to May 2009
- 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 60 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The elderly individuals were required to be in good physical and cognitive condition to be considered for the study
Who cannot join
- Eliminated participation by those who had acute-phase infections of the cardio-respiratory system and those who did not have a satisfactory cognitive level to understand the evaluation tests and the exercises performed in the treatment programs.
- Also excluded were people who presented skeletal muscle and neurological sequel, presented metabolic syndromes or failed to adhere to the training program for more than one week.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Marilia de Andrade Fonseca
Rio de Janeiro, Rio de Janeiro, 22780-160
About this study
Official title: Effects of the Breathing Muscular Training to Volume and the Pressure in MIP and MEP of Institutionalized Elderly
The purpose of this study was to use associated breathing exercises the incentive inspiratory of load lineal pressoric, Threshold® IMT, or of load pressoric alinear, Voldyne®, in institutionalized elderly, comparing the effect of the same ones in the training of the breathing musculature, for the increment of the muscular strength, expressed by the maximum breathing pressures (MIP and MEP).
From the total number of admitted people (n = 52), 12 individuals were excluded: one by appearance of cognitive deficit, one by death (stroke), one by visual deficit (glaucoma) and twelve by failure to continue the training. After selecting the sample, the 37 participants were randomly divided into three different groups: the Threshold Group (TG; n = 13, age = 70. 93 ± 8.41 years old, BMI = 24.06 ± 3.69 kg/m²), the Voldyne Group (VG; n = 12, age = 70.54 ± 7. 73 years-old, BMI = 27.17 ± 5.66 kg/m²) and the Control Group (CG; n= 12, age = 73. 92 ± 7.28 years-old, BMI = 24.80 ± 5.42 kg/m²). The TG and VG received treatment with respiratory exercises and Threshold and Voldyne muscular training, respectively. The CG received only respiratory exercises.
Read the detailed description
The physiologic alterations of the aging are systemic and they seem to be more evident in the institutionalized elderly. The advanced age is associated to the decrease of the force of the skeletal muscles, as well as the one of the muscles respiratory. In the breathing system happen important muscle-skeletal alterations, interfering in the mechanics ventilatory. The changes in the compliance of the thoracic wall and of the lung stcruture resulting in imprisonment of air, air-trapping ", increasing the breathing work simultaneously the and functional residual capacity (FRC) with consequent decrease of the pressure maximum expiratory. Also the decreases of the pick of flow expiratory and changes in the curve flow-volume contributing to the closing of the outlying aerial roads. This way the breathing muscular function will be strongly harmed and correlated with the state nutritional and it forces muscular outlying. Besides, modifications in the curvature of the diaphragm, with a negative effect for the capacity to generate muscular force, collaborating for the decrease inspiratory.
The participant was completely evaluated, including personal information, medical history and a physical examination.
Measurement of Translation provided gratis.
MIP and MEP: Before and after the respiratory muscle training, inspiratory and expiratory strength were evaluated and analysed through the maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), respectively. This was measured using a device called a vacuum manometer (analogical with operational intervals of -120 to + 120 cmH2O, Critical Med/USA-2002 and display with scale intervals of 4 cmH2O). During MIP measurements, a nasal clip was used, which prevented air from escaping during the evaluation. In MIP measurements, the mouth and oropharynx can create negative pressure that can alter the results depending on whether the glottis opens (correct form) or closes (improper form). To prevent this interference of the orofacial musculature in the MIP measurements, an escape orifice was placed in the measurement instrument. This orifice relieved the pressure without significantly affecting the pressure produced by the respiratory muscles. Five tests were carried out to get three acceptable measures (i.e., duration of at least 2 seconds and an absence of emptying).
Acceptable tests were required to have at least two reproducible measurements (a maximum difference of 5% between the two maxima). A rest of at least one minute between tests was used for better equalization of the volumes and (consequently) the attainment of maximum pressures. To measure MEP, the patient was instructed to inhale until reaching total pulmonary capacity (TPC) and to carry through a supported expiratory effort down to the residual volume (RV). A seated position was used when measuring both MIP and MEP.
Threshold Group Training: after the measurement of the initial MIP and MEP (pre-training), the elderly individuals of the TG were submitted to a respiratory exercise program. The research of Ide et al. (2007) showed that this program contributes to an increase in chest expansion in healthy elderly people. The program was composed of the following exercises: active/resistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint; active/resistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk; active/resistance exercise of lateral rotation of the trunk; active/resistance exercise to put the superior members above the head. The relaxation protocol consisted of inspiration and deep expiration without the accompaniment of other movements. After training, the Threshold® IMT (Respironics USA - 2004) was used. This device is commercially offered in the form of a transparent plastic cylinder; at one end is a valve that is kept closed for the positive pressure by a spring, while at the other end is a nipple. The valve blocks the aerial flow until the patient generates inspiratory pressure sufficient to overcome the spring.
The utilization of Threshold in this research began with a gradual load, starting with 50% of the MIP of each individual and increasing 10% per week until the fourth week. From the fifth week on, this was increased by 5% until 100% was reached in the eighth week or the maximum pressure value of the Threshold IMT (41 cmH2O) was reached. Thereafter, this value was kept constant in the final two weeks. The sessions lasted 20 minutes and consisted of seven series of strengthening (2 minutes each) with an interval of 1 minute between the series; sessions were conducted three times per week for ten weeks.
In the use of this training program, all the elderly individuals had been evaluated separately and trained in a group with individualized attention.
Voldyne Group Training: The same respiratory exercises used in the TG were used in the VG.
The maximum inspiratory sustentation technique (MIS) using the Voldyne mobilizes great pulmonary volumes and thereby increases the intra-alveolar pressure until the end of the supported inspiration. The increase in the intra-alveolar pressure is directly proportional to the contractile strength of the respiratory muscles (diaphragm and accessories), thus justifying the fact that intense muscular activity is required to reach the total pulmonary capacity (TPC) and to support inspiration at this level.
The use of EI (Voldyne®) incentive spirometry as muscular training in elderly people and as a basis for physiotherapy followed some guidelines. The patient's trunk was positioned at 30º relative to the horizontal plane, providing more diaphragmatic conscription. The device was positioned vertically. The volume indicator was visible to the patient to provide visual biofeedback. The patient was instructed to carry out a slow and deep inspiration until reaching TPC from the functional residual capacity (FRC). Slow inspiration favours a laminar flow. A sustentation of the maximum inspiration of around three seconds was recommended. Expiration occurred normally until the FRC was reached. During the use of Voldyne, patient hyperventilation was avoided. Intervals of 60 seconds between the inspiration support maxima were recommended 11. The elderly subjects received a verbal command to initiate a new inspiration. In this study, the Voldyne was used for 20 minutes, that is, 40 repetitions with 2 repetitions per minute. The procedure lasted 10 weeks at a frequency of three times per week. The group was supervised intermittently during the twenty minutes to ensure that hyperventilation was not occurring.
Control Group Training: This group received only respiratory exercises. The exercises was composed of the following exercises: active/resistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint; active/resistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk; active/resistance exercise of lateral rotation of the trunk; active/resistance exercise to put the superior members above the head. The relaxation protocol consisted of inspiration and deep expiration without the accompaniment of other movements.
Statistical Treatment:The average and standard deviation (av ± sd) were calculated for age, body mass index, maximum respiratory pressure and functional autonomy. The normality of the sample was evaluated by the Shapiro-Wilk test and the homogeneity of the variance by the test of Levene. For the within-groups analysis variables, the parametric Student's t test or Wilcoxon was used when appropriate (for homogeneous or heterogeneous distribution of the data, respectively). For the between-groups evaluation, the nonparametric Kruskal-Wallis test was used followed by the Mann-Whitney multiple comparisons test. The statistical significance level adopted was p < 0.05. Excel and the SPSS v14.0 statistical package program were used to evaluate the data.
- Conditions
- In Brazil, Which Has an Increasing Number of Elderly People., The Physiological Alterations of Aging Are Systemic.
- Being tested
- Comparison of different breathing muscular training
- Keywords
- Aged, Breathing Muscles, Strength Muscles, Institution of long Permanence for elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of different breathing muscular trainingOther
Also called Aged, Breathing Muscles, Strength Muscles.
Three times per week for ten weeks, thirty minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) in cmH2O
Measured: One minute
Secondary outcomes (1)
Before and after the respiratory muscle training, inspiratory and expiratory strength were evaluated and analysed through the maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), respectively.
Measured: Ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionMay 2009
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 In Brazil, Which Has an Increasing Number of Elderly People.Studies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Camilo Castelo Branco
- Sponsor type
- University, hospital or other
- Investigators
- Marilia A. Fonseca, Esp., Principal investigator, Universidaade Castelo BrancoSamaria A. Cader, Dr., Study director, Laboratory of Human Kinetics Bioscience from Castelo Branco University - LABIMH-UCB/Rio de Janeiro - RJ- BrazilSilvia C. Bacelar, Dr., Study chair, National Institute of Cancer (INCA) - Rio de Janeiro - RJ - BrazilElirez B. Silva, Dr., Study chair, Gama Filho University (UGF) - Rio de Janeiro - RJ - BrazilSilvânia O. Leal, Esp., Study chair, Laboratory of Human Kinetics Bioscience from Castelo Branco University - LABIMH-UCB/Rio de Janeiro - RJ- BrazilEstelio M. Dantas, Phd., Study director, Laboratory of Human Kinetics Bioscience from Castelo Branco University LABIMH-UCB/ Rio de Janeiro- RJ- Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001156
- Sponsor's protocol ID
- 0043-2008
- Status last verified
- Oct 2009
- First submitted
- 21 Oct 2009
- Last updated
- 23 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hill K, Jenkins SC, Philippe DL, Cecins N, Shepherd KL, Green DJ, Hillman DR, Eastwood PR. High-intensity inspiratory muscle training in COPD. Eur Respir J. 2006 Jun;27(6):1119-28. doi: 10.1183/09031936.06.00105205.
PubMed 16772388
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Breathing Muscular Training to Volume and the Pressure in MIP and MEP of Institutionalized Elderly
- ClinicalTrials.gov ID
- NCT01001156
- Acronym / sponsor ID
- 0043-2008
- Conditions
- In Brazil, Which Has an Increasing Number of Elderly People., The Physiological Alterations of Aging Are Systemic.
- Keywords
- Aged, Breathing Muscles, Strength Muscles, Institution of long Permanence for elderly
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universidade Camilo Castelo BrancoUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Oct 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.
The purpose of this study was to use associated breathing exercises the incentive inspiratory of load lineal pressoric, Threshold® IMT, or of load pressoric alinear, Voldyne®, in institutionalized elderly, comparing the effect of the same ones in the training of the breathing musculature, for the increment of the muscular strength, expressed by the maximum breathing pressures (MIP and MEP).
From the total number of admitted people (n = 52), 12 individuals were excluded: one by appearance of cognitive deficit, one by death (stroke), one by visual deficit (glaucoma) and twelve by failure to continue the training. After selecting the sample, the 37 participants were randomly divided into three different groups: the Threshold Group (TG; n = 13, age = 70. 93 ± 8.41 years old, BMI = 24.06 ± 3.69 kg/m²), the Voldyne Group (VG; n = 12, age = 70.54 ± 7. 73 years-old, BMI = 27.17 ± 5.66 kg/m²) and the Control Group (CG; n= 12, age = 73. 92 ± 7.28 years-old, BMI = 24.80 ± 5.42 kg/m²). The TG and VG received treatment with respiratory exercises and Threshold and Voldyne muscular training, respectively. The CG received only respiratory exercises.
Detailed description
The physiologic alterations of the aging are systemic and they seem to be more evident in the institutionalized elderly. The advanced age is associated to the decrease of the force of the skeletal muscles, as well as the one of the muscles respiratory. In the breathing system happen important muscle-skeletal alterations, interfering in the mechanics ventilatory. The changes in the compliance of the thoracic wall and of the lung stcruture resulting in imprisonment of air, air-trapping ", increasing the breathing work simultaneously the and functional residual capacity (FRC) with consequent decrease of the pressure maximum expiratory. Also the decreases of the pick of flow expiratory and changes in the curve flow-volume contributing to the closing of the outlying aerial roads. This way the breathing muscular function will be strongly harmed and correlated with the state nutritional and it forces muscular outlying. Besides, modifications in the curvature of the diaphragm, with a negative effect for the capacity to generate muscular force, collaborating for the decrease inspiratory.
The participant was completely evaluated, including personal information, medical history and a physical examination.
Measurement of Translation provided gratis.
MIP and MEP: Before and after the respiratory muscle training, inspiratory and expiratory strength were evaluated and analysed through the maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), respectively. This was measured using a device called a vacuum manometer (analogical with operational intervals of -120 to + 120 cmH2O, Critical Med/USA-2002 and display with scale intervals of 4 cmH2O). During MIP measurements, a nasal clip was used, which prevented air from escaping during the evaluation. In MIP measurements, the mouth and oropharynx can create negative pressure that can alter the results depending on whether the glottis opens (correct form) or closes (improper form). To prevent this interference of the orofacial musculature in the MIP measurements, an escape orifice was placed in the measurement instrument. This orifice relieved the pressure without significantly affecting the pressure produced by the respiratory muscles. Five tests were carried out to get three acceptable measures (i.e., duration of at least 2 seconds and an absence of emptying).
Acceptable tests were required to have at least two reproducible measurements (a maximum difference of 5% between the two maxima). A rest of at least one minute between tests was used for better equalization of the volumes and (consequently) the attainment of maximum pressures. To measure MEP, the patient was instructed to inhale until reaching total pulmonary capacity (TPC) and to carry through a supported expiratory effort down to the residual volume (RV). A seated position was used when measuring both MIP and MEP.
Threshold Group Training: after the measurement of the initial MIP and MEP (pre-training), the elderly individuals of the TG were submitted to a respiratory exercise program. The research of Ide et al. (2007) showed that this program contributes to an increase in chest expansion in healthy elderly people. The program was composed of the following exercises: active/resistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint; active/resistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk; active/resistance exercise of lateral rotation of the trunk; active/resistance exercise to put the superior members above the head. The relaxation protocol consisted of inspiration and deep expiration without the accompaniment of other movements. After training, the Threshold® IMT (Respironics USA - 2004) was used. This device is commercially offered in the form of a transparent plastic cylinder; at one end is a valve that is kept closed for the positive pressure by a spring, while at the other end is a nipple. The valve blocks the aerial flow until the patient generates inspiratory pressure sufficient to overcome the spring.
The utilization of Threshold in this research began with a gradual load, starting with 50% of the MIP of each individual and increasing 10% per week until the fourth week. From the fifth week on, this was increased by 5% until 100% was reached in the eighth week or the maximum pressure value of the Threshold IMT (41 cmH2O) was reached. Thereafter, this value was kept constant in the final two weeks. The sessions lasted 20 minutes and consisted of seven series of strengthening (2 minutes each) with an interval of 1 minute between the series; sessions were conducted three times per week for ten weeks.
In the use of this training program, all the elderly individuals had been evaluated separately and trained in a group with individualized attention.
Voldyne Group Training: The same respiratory exercises used in the TG were used in the VG.
The maximum inspiratory sustentation technique (MIS) using the Voldyne mobilizes great pulmonary volumes and thereby increases the intra-alveolar pressure until the end of the supported inspiration. The increase in the intra-alveolar pressure is directly proportional to the contractile strength of the respiratory muscles (diaphragm and accessories), thus justifying the fact that intense muscular activity is required to reach the total pulmonary capacity (TPC) and to support inspiration at this level.
The use of EI (Voldyne®) incentive spirometry as muscular training in elderly people and as a basis for physiotherapy followed some guidelines. The patient's trunk was positioned at 30º relative to the horizontal plane, providing more diaphragmatic conscription. The device was positioned vertically. The volume indicator was visible to the patient to provide visual biofeedback. The patient was instructed to carry out a slow and deep inspiration until reaching TPC from the functional residual capacity (FRC). Slow inspiration favours a laminar flow. A sustentation of the maximum inspiration of around three seconds was recommended. Expiration occurred normally until the FRC was reached. During the use of Voldyne, patient hyperventilation was avoided. Intervals of 60 seconds between the inspiration support maxima were recommended 11. The elderly subjects received a verbal command to initiate a new inspiration. In this study, the Voldyne was used for 20 minutes, that is, 40 repetitions with 2 repetitions per minute. The procedure lasted 10 weeks at a frequency of three times per week. The group was supervised intermittently during the twenty minutes to ensure that hyperventilation was not occurring.
Control Group Training: This group received only respiratory exercises. The exercises was composed of the following exercises: active/resistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint; active/resistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk; active/resistance exercise of lateral rotation of the trunk; active/resistance exercise to put the superior members above the head. The relaxation protocol consisted of inspiration and deep expiration without the accompaniment of other movements.
Statistical Treatment:The average and standard deviation (av ± sd) were calculated for age, body mass index, maximum respiratory pressure and functional autonomy. The normality of the sample was evaluated by the Shapiro-Wilk test and the homogeneity of the variance by the test of Levene. For the within-groups analysis variables, the parametric Student's t test or Wilcoxon was used when appropriate (for homogeneous or heterogeneous distribution of the data, respectively). For the between-groups evaluation, the nonparametric Kruskal-Wallis test was used followed by the Mann-Whitney multiple comparisons test. The statistical significance level adopted was p < 0.05. Excel and the SPSS v14.0 statistical package program were used to evaluate the data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The elderly individuals were required to be in good physical and cognitive condition to be considered for the study
Key exclusion criteria (2 listed)
- Eliminated participation by those who had acute-phase infections of the cardio-respiratory system and those who did not have a satisfactory cognitive level to understand the evaluation tests and the exercises performed in the treatment programs.
- Also excluded were people who presented skeletal muscle and neurological sequel, presented metabolic syndromes or failed to adhere to the training program for more than one week.
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 |
|---|---|---|
| Comparison of different breathing muscular trainingAlso: Aged, Breathing Muscles, Strength Muscles.Three times per week for ten weeks, thirty minutes. | Other | – |
Primary outcome
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) in cmH2O
Time frame: One minute
1 secondary outcome
Before and after the respiratory muscle training, inspiratory and expiratory strength were evaluated and analysed through the maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), respectively.
Time frame: Ten 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 23 Oct 2009.
- Results publication: PubMed 16772388Hill K, Jenkins SC, Philippe DL, Cecins N, Shepherd KL, Green DJ, Hillman DR, Eastwood PR. High-intensity inspiratory muscle training in COPD. Eur Respir J. 2006 Jun;27(6):1119-28. doi: 10.1183/09031936.06.00105205.
- Comparative study of elderly inpatients clinically diagnosed with community-acquired pneumonia, with or without radiological confirmation.Link provided by the sponsor.
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.
Marilia A. Fonseca, Esp. principal investigator
Universidaade Castelo Branco
Samaria A. Cader, Dr. study director
Laboratory of Human Kinetics Bioscience from Castelo Branco University - LABIMH-UCB/Rio de Janeiro - RJ- Brazil
Silvia C. Bacelar, Dr. study chair
National Institute of Cancer (INCA) - Rio de Janeiro - RJ - Brazil
1 site 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 Comparison of different breathing muscular training in people with In Brazil, Which Has an Increasing Number of Elderly People. and The Physiological Alterations of Aging Are Systemic., run by Universidade Camilo Castelo Branco 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 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 23 Oct 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 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?
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) in cmH2O (time frame: One minute). 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 NCT01001156, 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 23 Oct 2009.