NCT02384798

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable heart-failure

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

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 16, 2015

Last Update Submit

March 4, 2015

Conditions

Heart Failure

Outcome Measures

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.

    AFTER 12 WEEKS FOLLOW

Secondary Outcomes (5)

  • double product

    AFTER 12 WEEKS FOLLOW

  • spirometry

    AFTER 12 WEEKS FOLLOW

  • minnesota questionnaire

    AFTER 12 WEEKS FOLLOW

  • SF-36 questionnaire

    AFTER 12 WEEKS FOLLOW

  • Functional Independence Measure questionnaire

    AFTER 12 WEEKS FOLLOW

Study Arms (2)

ventilatory support

EXPERIMENTAL

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 supportOther: interval training

interval training

ACTIVE COMPARATOR

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

Other: interval training

Interventions

noninvasive ventilatory supportOTHER

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
ventilatory support
interval trainingOTHER

interval training

Also known as: concurrent training
interval trainingventilatory support

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 10987815RESULT

  • 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.

    PMID: 28378600DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • MANSUETO G NETO

    Federal University of Bahia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy course coordinator

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 10, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

March 10, 2015

Record last verified: 2015-03