Muscular AtrophyNCT01791010
Effects of Inspiratory Muscle Training in Elders
A study testing Inspiratory muscle training in people with Muscular Atrophy and Sensitivity Training Groups, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Aging causes anatomical and physiological changes in the respiratory system and respiratory muscle strength with decline in its maximum function. This study aimed to evaluate the effects of inspiratory muscle training on respiratory muscle strength, thickness of the diaphragm and diaphragmatic mobility in older women. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscular Atrophy, Sensitivity Training Groups, Aging
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Dec 2012
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly women are able to walk without aid and cognitive integrity.
Who cannot join
- Participation in other training or rehabilitation protocol;
- Contraindication or difficult to perform the evaluation;
- Difficulty adapting or adherence in training protocol;
- Smoking;
- Hemodynamic instability;
- Degenerative neuromuscular disease;
Show all 9Show fewer
- Pulmonary comorbidities;
- Heart disease;
- Users of drugs that interfere in bone metabolism or muscle strength.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Muscle Training in the Elderly: a Strategy for Preservation of Inspiratory and Expiratory Pressures Impacting on Mobility and Thickness of the Diaphragm.
Aging causes anatomical and physiological changes in the respiratory system and respiratory muscle strength with decline in its maximum function. This study aimed to evaluate the effects of inspiratory muscle training on respiratory muscle strength, thickness of the diaphragm and diaphragmatic mobility in older women. The investigators' hypothesis is that inspiratory muscle training improves respiratory muscle strength, the thickness of the diaphragm and diaphragmatic mobility in older women.
- Conditions
- Muscular Atrophy, Sensitivity Training Groups, Aging
- Being tested
- Inspiratory muscle training, Training sham
- Keywords
- Breathing exercises, Aged
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Also called respiratory muscle training
Training shamOther
Conducting fake training with the aim of blind the control group
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training | Experimental | Inspiratory muscle training for 8 weeks using a device that provides a linear resistance in the inspiratory phase. 7 days a week. 8 sets of 2 minutes twice a day. Intensity was at 40% of Maximal Inspiratory Pressure. Receives: Other: Inspiratory muscle training |
| Training sham | Sham comparator | Training sham for 8 weeks using a device without provides resistance. 7 days a week. 8 sets of 2 minutes twice a day. Intensity was canceled. Receives: Other: Training sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory muscle strength
Measured: Change from Baseline Respiratory Muscle Strength at 2 months
Secondary outcomes (1)
Diafragmatic excursion and thickness of the diaphragm in the zone of apposition by ultrasonography
Ultrasound was used to evaluate diaphragm thickness non-invasively in the zone of apposition during tidal breathing and with changes in lung volume.
During respiration to total lung capacity, measurement of the diafragmatic excursion was made by ultrasonography.
Measured: Change from Baseline Diafragmatic Excursion and Thickness of the Diaphragm at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscular AtrophyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helga Cecília Muniz de Souza, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791010
- Sponsor's protocol ID
- IMT in elders
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2013
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Testa A, Soldati G, Giannuzzi R, Berardi S, Portale G, Gentiloni Silveri N. Ultrasound M-mode assessment of diaphragmatic kinetics by anterior transverse scanning in healthy subjects. Ultrasound Med Biol. 2011 Jan;37(1):44-52. doi: 10.1016/j.ultrasmedbio.2010.10.004.
PubMed 21144957Ueki J, De Bruin PF, Pride NB. In vivo assessment of diaphragm contraction by ultrasound in normal subjects. Thorax. 1995 Nov;50(11):1157-61. doi: 10.1136/thx.50.11.1157.
PubMed 8553271Enright SJ, Unnithan VB, Heward C, Withnall L, Davies DH. Effect of high-intensity inspiratory muscle training on lung volumes, diaphragm thickness, and exercise capacity in subjects who are healthy. Phys Ther. 2006 Mar;86(3):345-54.
PubMed 16506871
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Training in the Elderly: a Strategy for Preservation of Inspiratory and Expiratory Pressures Impacting on Mobility and Thickness of the Diaphragm.
- ClinicalTrials.gov ID
- NCT01791010
- Acronym / sponsor ID
- IMT in elders
- Conditions
- Muscular Atrophy, Sensitivity Training Groups, Aging
- Keywords
- Breathing exercises, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Feb 2013 (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.
Aging causes anatomical and physiological changes in the respiratory system and respiratory muscle strength with decline in its maximum function. This study aimed to evaluate the effects of inspiratory muscle training on respiratory muscle strength, thickness of the diaphragm and diaphragmatic mobility in older women. The investigators' hypothesis is that inspiratory muscle training improves respiratory muscle strength, the thickness of the diaphragm and diaphragmatic mobility in older women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training | Experimental | Other: Inspiratory muscle trainingInspiratory muscle training for 8 weeks using a device that provides a linear resistance in the inspiratory phase. 7 days a week. 8 sets of 2 minutes twice a day. Intensity was at 40% of Maximal Inspiratory Pressure. |
| Training sham | Sham comparator | Other: Training shamTraining sham for 8 weeks using a device without provides resistance. 7 days a week. 8 sets of 2 minutes twice a day. Intensity was canceled. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elderly women are able to walk without aid and cognitive integrity.
Key exclusion criteria (9 listed)
- Participation in other training or rehabilitation protocol;
- Contraindication or difficult to perform the evaluation;
- Difficulty adapting or adherence in training protocol;
- Smoking;
- Hemodynamic instability;
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 trainingAlso: respiratory muscle training | Other | Inspiratory muscle training |
| Training shamConducting fake training with the aim of blind the control group | Other | Training sham |
Primary outcome
respiratory muscle strength
Time frame: Change from Baseline Respiratory Muscle Strength at 2 months
1 secondary outcome
Diafragmatic excursion and thickness of the diaphragm in the zone of apposition by ultrasonography
Time frame: Change from Baseline Diafragmatic Excursion and Thickness of the Diaphragm at 2 months
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 13 Feb 2013.
- Background: PubMed 21144957Testa A, Soldati G, Giannuzzi R, Berardi S, Portale G, Gentiloni Silveri N. Ultrasound M-mode assessment of diaphragmatic kinetics by anterior transverse scanning in healthy subjects. Ultrasound Med Biol. 2011 Jan;37(1):44-52. doi: 10.1016/j.ultrasmedbio.2010.10.004.
- Background: PubMed 8553271Ueki J, De Bruin PF, Pride NB. In vivo assessment of diaphragm contraction by ultrasound in normal subjects. Thorax. 1995 Nov;50(11):1157-61. doi: 10.1136/thx.50.11.1157.
- Background: PubMed 16506871Enright SJ, Unnithan VB, Heward C, Withnall L, Davies DH. Effect of high-intensity inspiratory muscle training on lung volumes, diaphragm thickness, and exercise capacity in subjects who are healthy. Phys Ther. 2006 Mar;86(3):345-54.
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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 Muscular Atrophy and Sensitivity Training Groups, run by Universidade Federal de Pernambuco 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 9 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 13 Feb 2013. 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?
respiratory muscle strength (time frame: Change from Baseline Respiratory Muscle Strength at 2 months). 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 NCT01791010, which also lists 3 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 13 Feb 2013.