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CompletedNCT02384798SVNIUpdated Mar 10, 2015

Ventilatory Support Associated With Exercise in Heart Failure

An interventional study of noninvasive ventilatory support and interval training in Heart Failure, sponsored by Federal University of Bahia. Completed. Per ClinicalTrials.gov, last updated 2015-03-10.

Sponsored by Federal University of Bahia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
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Study summary

Due to the symptoms of heart failure (HF), as dyspnea and fatigue, patients have a reduced functional capacity, evidenced during usual daily activities and exercises. The Cardiac Rehabilitation with emphasis on resistance and aerobic exercises performed in the same session (concurrent training), can be added to pharmacological treatment as improvement strategy in functional capacity and quality of life.

Read the detailed description

A randomized clinical trial, divided into two stages will be held. In step 1 the function will be assessed by the 6-minute walk test, spirometry, and questionnaires to evaluate quality of life. After fulfilled the series of assessments individuals will be randomly divided into two groups, with group 1 (control) will hold only one interval aerobic exercise program on treadmill and group 2 (intervention) will hold a combined exercise program for prior use of ventilatory support noninvasive. For both groups will be held an aerobic exercise program associated with resistance exercise for 12 weeks. The first two weeks will be considered in period. In the 10 weeks following both groups maintain the preset exercise program gradually. In the intervention group will be added before the exercise program the use of noninvasive ventilation for 30 minutes.

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Conditions studied

  • Heart Failure

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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 60 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Federal University of Bahia is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Will be included 60 patients of both sexes, adults with medical diagnosis divided into two groups: Group A consisted of 30 patients use non-invasive ventilation added to interval training and group B consisted of 30 patients also only use interval training.

Exclusion criteria

Exclusion Criteria:

  • Will be excluded from the study patients who have chest pain (angina), arrhythmias, spo2 ≤ 90%, hypertension or hypotension, neurological or osteoarticular disease preventing the ambulation of these individuals.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    ventilatory support

    noninvasive ventilatory support to 5cmH2O used before the session of interval training and resistance exercises performed three times a week for 12 weeks

    Other: noninvasive ventilatory support · Other: interval training

  • Active comparator
    interval training

    sessions of interval training and resistance exercises performed three times a week for 12 weeks

    Other: interval training

Interventions

  • Othernoninvasive ventilatory support

    noninvasive ventilatory support with 5-minute ramp and positive end expiratory pressure (PEEP) of 5 cm H2O for 30 minutes, then there will be the interval aerobic training on a treadmill added to resistance exercises

    Also known as: CPAP of redmed brand

  • Otherinterval training

    interval training

    Also known as: concurrent training

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What researchers measure

Primary outcomes

  1. SIX MINUTES WALK TEST

    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.

    Time frame: AFTER 12 WEEKS FOLLOW

Secondary outcomes

  1. double product

    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.

    Time frame: AFTER 12 WEEKS FOLLOW

  2. spirometry

    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.

    Time frame: AFTER 12 WEEKS FOLLOW

  3. minnesota questionnaire

    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.

    Time frame: AFTER 12 WEEKS FOLLOW

  4. SF-36 questionnaire

    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.

    Time frame: AFTER 12 WEEKS FOLLOW

  5. Functional Independence Measure questionnaire

    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.

    Time frame: AFTER 12 WEEKS FOLLOW

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Paterson JM, Smith SM, Simpson J, Grace OC, Sosunov AA, Bell JE, Antoni FA. Characterisation of human adenylyl cyclase IX reveals inhibition by Ca(2+)/Calcineurin and differential mRNA plyadenylation. J Neurochem. 2000 Oct;75(4):1358-67. doi: 10.1046/j.1471-4159.2000.0751358.x. PubMed 10987815 ↗
  • Bittencourt HS, Cruz CG, David BC, Rodrigues E Jr, Abade CM, Junior RA, Carvalho VO, Dos Reis FBF, Gomes Neto M. Addition of non-invasive ventilatory support to combined aerobic and resistance training improves dyspnea and quality of life in heart failure patients: a randomized controlled trial. Clin Rehabil. 2017 Nov;31(11):1508-1515. doi: 10.1177/0269215517704269. Epub 2017 Apr 5. PubMed 28378600 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02384798
Lead sponsor
Federal University of Bahia
Collaborators
Hospital Ana Nery
Responsible party
Mansueto Gomes Neto (Physiotherapy course coordinator, Federal University of Bahia) — Principal investigator
First posted
Mar 10, 2015
Start date
Jan 2014
Primary completion
Jan 2015
Completion
Feb 2015
Last update
Mar 10, 2015

Study contacts

MANSUETO G NETO
principal investigator · Federal University of Bahia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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