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Effects of Inspiratory Muscle Training in Elders

Primary Purpose

Muscular Atrophy, Sensitivity Training Groups, Aging

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle training
Training sham
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Atrophy focused on measuring Breathing exercises, Aged

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of Pernambuco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inspiratory muscle training

Training sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

respiratory muscle strength

Secondary Outcome Measures

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.

Full Information

First Posted
February 6, 2013
Last Updated
February 9, 2013
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT01791010
Brief Title
Effects of Inspiratory Muscle Training in Elders
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Atrophy, Sensitivity Training Groups, Aging
Keywords
Breathing exercises, Aged

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
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.
Arm Title
Training sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Other Intervention Name(s)
respiratory muscle training
Intervention Type
Other
Intervention Name(s)
Training sham
Intervention Description
Conducting fake training with the aim of blind the control group
Primary Outcome Measure Information:
Title
respiratory muscle strength
Time Frame
Change from Baseline Respiratory Muscle Strength at 2 months
Secondary Outcome Measure Information:
Title
Diafragmatic excursion and thickness of the diaphragm in the zone of apposition by ultrasonography
Description
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.
Time Frame
Change from Baseline Diafragmatic Excursion and Thickness of the Diaphragm at 2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Federal University of Pernambuco
City
Recife
State/Province
Pernambuco
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21144957
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.
Results Reference
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PubMed Identifier
8553271
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. doi: 10.1136/thx.50.11.1157.
Results Reference
background
PubMed Identifier
16506871
Citation
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.
Results Reference
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Effects of Inspiratory Muscle Training in Elders

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