- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01791010
Effects of Inspiratory Muscle Training in Elders
February 9, 2013 updated by: Helga Cecília Muniz de Souza, Universidade Federal de Pernambuco
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pernambuco
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Recife, Pernambuco, Brazil
- Federal University of Pernambuco
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Elderly women are able to walk without aid and cognitive integrity.
Exclusion Criteria:
- 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;
- Pulmonary comorbidities;
- Heart disease;
- Users of drugs that interfere in bone metabolism or muscle strength.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inspiratory muscle training
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.
|
Other Names:
|
Sham Comparator: Training sham
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.
|
Conducting fake training with the aim of blind the control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
respiratory muscle strength
Time Frame: Change from Baseline Respiratory Muscle Strength at 2 months
|
Change from Baseline Respiratory Muscle Strength at 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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. |
Change from Baseline Diafragmatic Excursion and Thickness of the Diaphragm at 2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Ueki 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.
- Enright 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
February 6, 2013
First Submitted That Met QC Criteria
February 9, 2013
First Posted (Estimate)
February 13, 2013
Study Record Updates
Last Update Posted (Estimate)
February 13, 2013
Last Update Submitted That Met QC Criteria
February 9, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMT in elders
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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