NCT00966303

Brief Summary

This quantitative study aimed to evaluate the respiratory muscle strength, pulmonary function, cardiovascular function, and impact on quality of life in patients after cardiac rehabilitation associated with the diaphragmatic muscle training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

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

June 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
Last Updated

October 6, 2009

Status Verified

October 1, 2009

Enrollment Period

10 months

First QC Date

August 25, 2009

Last Update Submit

October 5, 2009

Conditions

Cardiomyopathies

Keywords

rehabilitationdyspneastrength

Outcome Measures

Primary Outcomes (1)

  • The effectiveness of a cardiac rehabilitation in patients with cardiomyopathy, evaluating the respiratory muscle strength, pulmonary function, cardiovascular function, and impact on quality of life.

    8 weeks / Twice a week

Study Arms (1)

Cardiac Rehabilitation

EXPERIMENTAL

9 patients with cardiomyopathy in functional class III or IV, submitted to an 8-week program with exercises and respiratory muscle training.

Other: Cardiac Rehabilitation with diaphragmatic muscle training

Interventions

Cardiac Rehabilitation with diaphragmatic muscle trainingOTHER

Stretching and aerobic exercises and respiratory muscle training with a Threshold ® device, with load of 40% of the maximal inspiratory pressure (MIP), two times a week during one hour.

Cardiac Rehabilitation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Cardiomyopathies in functional class III or IV (New York Heart Association)
  • Aged over 18 years
  • Body mass index below 30 kg/m2

You may not qualify if:

  • Confused and depressed patients
  • Cardiac instability and worsening dyspnea after initiation of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortaleza University - Nucleus of Integrated Medical Attention

Fortaleza, Ceará, Brazil

Location

MeSH Terms

Conditions

CardiomyopathiesDyspnea

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Davi S Sales, Bachelor

    Fortaleza University

    PRINCIPAL INVESTIGATOR

  • Daniela GB Mont'Alverne, Doctor

    Fortaleza University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

June 1, 2008

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

October 6, 2009

Record last verified: 2009-10

Locations

BR(1)