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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01791010
Other study ID # IMT in elders
Secondary ID
Status Completed
Phase N/A
First received February 6, 2013
Last updated February 9, 2013
Start date January 2012
Est. completion date December 2012

Study information

Verified date February 2013
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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. The investigators' hypothesis is that inspiratory muscle training improves respiratory muscle strength, the thickness of the diaphragm and diaphragmatic mobility in older women.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Inspiratory muscle training

Training sham
Conducting fake training with the aim of blind the control group

Locations

Country Name City State
Brazil Federal University of Pernambuco Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary respiratory muscle strength Change from Baseline Respiratory Muscle Strength at 2 months No
Secondary 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.
Change from Baseline Diafragmatic Excursion and Thickness of the Diaphragm at 2 months No
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