NCT01791010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

11 months

First QC Date

February 6, 2013

Last Update Submit

February 9, 2013

Conditions

Muscular AtrophySensitivity Training GroupsAging

Keywords

Breathing exercisesAged

Outcome Measures

Primary Outcomes (1)

  • respiratory muscle strength

    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

    Change from Baseline Diafragmatic Excursion and Thickness of the Diaphragm at 2 months

Study Arms (2)

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.

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.

Other: Training sham

Interventions

Inspiratory muscle trainingOTHER
Also known as: respiratory muscle training
Inspiratory muscle training
Training shamOTHER

Conducting fake training with the aim of blind the control group

Training sham

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly women are able to walk without aid and cognitive integrity.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 21144957BACKGROUND

  • 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.

    PMID: 8553271BACKGROUND

  • 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.

    PMID: 16506871BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 13, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

BR(1)