NCT01001156

Brief Summary

The purpose of this study was to use associated breathing exercises the incentive inspiratory of load lineal pressoric, Threshold® IMT, or of load pressoric alinear, Voldyne®, in institutionalized elderly, comparing the effect of the same ones in the training of the breathing musculature, for the increment of the muscular strength, expressed by the maximum breathing pressures (MIP and MEP). From the total number of admitted people (n = 52), 12 individuals were excluded: one by appearance of cognitive deficit, one by death (stroke), one by visual deficit (glaucoma) and twelve by failure to continue the training. After selecting the sample, the 37 participants were randomly divided into three different groups: the Threshold Group (TG; n = 13, age = 70. 93 ± 8.41 years old, BMI = 24.06 ± 3.69 kg/m²), the Voldyne Group (VG; n = 12, age = 70.54 ± 7. 73 years-old, BMI = 27.17 ± 5.66 kg/m²) and the Control Group (CG; n= 12, age = 73. 92 ± 7.28 years-old, BMI = 24.80 ± 5.42 kg/m²). The TG and VG received treatment with respiratory exercises and Threshold and Voldyne muscular training, respectively. The CG received only respiratory exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
Last Updated

October 23, 2009

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

October 21, 2009

Last Update Submit

October 22, 2009

Conditions

Keywords

AgedBreathing MusclesStrength MusclesInstitution of long Permanence for elderly

Outcome Measures

Primary Outcomes (1)

  • Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) in cmH2O

    One minute

Secondary Outcomes (1)

  • Before and after the respiratory muscle training, inspiratory and expiratory strength were evaluated and analysed through the maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), respectively.

    Ten weeks

Interventions

Three times per week for ten weeks, thirty minutes.

Also known as: Aged, Breathing Muscles, Strength Muscles.

Eligibility Criteria

Age60 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The elderly individuals were required to be in good physical and cognitive condition to be considered for the study

You may not qualify if:

  • Eliminated participation by those who had acute-phase infections of the cardio-respiratory system and those who did not have a satisfactory cognitive level to understand the evaluation tests and the exercises performed in the treatment programs.
  • Also excluded were people who presented skeletal muscle and neurological sequel, presented metabolic syndromes or failed to adhere to the training program for more than one week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marilia de Andrade Fonseca

Rio de Janeiro, Rio de Janeiro, 22780-160, Brazil

Location

Related Publications (1)

  • Hill K, Jenkins SC, Philippe DL, Cecins N, Shepherd KL, Green DJ, Hillman DR, Eastwood PR. High-intensity inspiratory muscle training in COPD. Eur Respir J. 2006 Jun;27(6):1119-28. doi: 10.1183/09031936.06.00105205.

Related Links

MeSH Terms

Interventions

Aging

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • Marilia A. Fonseca, Esp.

    Universidaade Castelo Branco

    PRINCIPAL INVESTIGATOR
  • Samaria A. Cader, Dr.

    Laboratory of Human Kinetics Bioscience from Castelo Branco University - LABIMH-UCB/Rio de Janeiro - RJ- Brazil

    STUDY DIRECTOR
  • Silvia C. Bacelar, Dr.

    National Institute of Cancer (INCA) - Rio de Janeiro - RJ - Brazil

    STUDY CHAIR
  • Elirez B. Silva, Dr.

    Gama Filho University (UGF) - Rio de Janeiro - RJ - Brazil

    STUDY CHAIR
  • Silvânia O. Leal, Esp.

    Laboratory of Human Kinetics Bioscience from Castelo Branco University - LABIMH-UCB/Rio de Janeiro - RJ- Brazil

    STUDY CHAIR
  • Estelio M. Dantas, Phd.

    Laboratory of Human Kinetics Bioscience from Castelo Branco University LABIMH-UCB/ Rio de Janeiro- RJ- Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 23, 2009

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

May 1, 2009

Last Updated

October 23, 2009

Record last verified: 2009-10

Locations