NCT01912482

Brief Summary

The cardiorespiratory training can increase muscle strength ventilatory.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 3, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1.9 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

June 3, 2013

Last Update Submit

January 3, 2015

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

  • Ventilatory muscle strength

    The MIP and MEP are measured by a digital manometer 300(BRAZIL). During the measurement the participants should be seated in a chair type office allowing your upper body to remain in contact with the back of it, forming an angle of 90° to the hip, the arms extended along the body, knees flexed too 90° and feet flat on the floor. Participants will use a nose clip. The evaluator will manually compress the face of the participant not allowing the contraction of the buccinator muscles increase intraoral pressure and interfere with the measurement result. In the measurement of MIP participants should hold a maximum inspiration from residual volume (RV) and MEP maximum exhalation from total lung capacity (TLC).

    The ventilatory muscle strength (MIP and MEP) will be measured after 18 cardiorespiratory training sessions held in 6 weeks.

Study Arms (3)

Cardiorespiratory training

EXPERIMENTAL

The cardiorespiratory training group will undergo 18 sessions, these also periodized in a maximum six weeks, respecting the minimum weekly frequency of 3 sessions.

Other: Cardiorespiratory training

Ventilatory Training

ACTIVE COMPARATOR

The ventilatory training group will undergo 18 sessions, periodized in a maximum six weeks, respecting the minimum weekly frequency of three sessions.

Other: ventilatory training

Crontrol Group

NO INTERVENTION

This condition will last six weeks, this period will be held six lectures sixty minutes long and periodization weekly.

Interventions

Cardiorespiratory trainingOTHER

The cardiorespiratory training group will undergo 18 sessions, these also periodized in a maximum six weeks, respecting the minimum weekly frequency of 3 sessions.

Also known as: GTC
Cardiorespiratory training
ventilatory trainingOTHER

The ventilatory training group will undergo 18 sessions, periodized in a maximum six weeks, respecting the minimum weekly frequency of three sessions.

Also known as: GTV
Ventilatory Training

Eligibility Criteria

Age60 Years - 79 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Have lower maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values normative reference proposed by the Brazilian Society of Thoracic.

You may not qualify if:

  • Not be voluntary to the present study.
  • Conditions that oblige participants are absent for more than two weeks of activities performed in the experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gama Filho University

Rio de Janeiro, Rio de Janeiro, 23050-260, Brazil

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Fabio D Pereira, MSc

    Gama Filho University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio D Pereira, MSc

CONTACT

552178705024profabiodutra@hotmail.com

Elirez B Silva, Doctoral

CONTACT

552125997170elirezsilva@ugf.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chronic effect of cardiorespiratory training on ventilatory muscle strength in elderly women: Experiment controlled, randomized and double blind.

Study Record Dates

First Submitted

June 3, 2013

First Posted

July 31, 2013

Study Start

July 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations

BR(1)