NCT01454128

Brief Summary

Heart failure (HF) is a complex syndrome characterized by myocardial dysfunction and an impaired regulatory function of multiple organ systems which were resulted from impaired cardiac output and consequently impaired perfusion of target organ. In cardiopulmonary exercise test (CPET), the investigators found there is periodic oscillation in minute ventilation of some patient. With periodic breathing (PB), clear oscillations in oxygen uptake, carbon dioxide output, tidal volume and left ventricle ejection fraction (LVEF) were also noted. Exertional hyper-ventilation that is caused by HF may further induce vasoconstriction during exercise and lead to further dysfunction of end-organ and muscle. Reduced end-organ perfusion/oxygenation may critically limit exercise performance. Hypoxic change during nadir phase of PB may deteriorate the exercise limitation. Physical training can have beneficial effects which can effectively counteract the progression of deleterious compensatory mechanisms of HF. Whether exercise yields the same beneficial effect on ventilation oscillation and inefficacy is not clear. The investigators will observe the real-time cardiac and hemodynamic change respond to exercise with periodic breathing change. The investigators expect that these results obtained from this study can aid in determining appropriate exercise intervention to improve aerobic fitness as well as simultaneously improve hemodynamic control in patients with HF. A quasi-experimental design will be used in this investigation. 60 HF patients will be recruited from Chang Gung Medical Foundation, Keelung Branch after they have provided informed consent. These subjects will be divided into PB (n=30) and non-PB groups (n=30) by their expression of CPET. Patients from each groups received the same therapy and trace course for 2years including CV clinics, CPET and polysomnography. The investigators will measure subjects' physical fitness, oxygen transport and utilization of exercising skeletal muscles, cardiovascular functions and hemodynamics, blood cell parameters, RBC deformity and aggregation, plasma biomarkers of myocardial damage, oxygen stress and quality of life at pre-training stage and following the 6th , 12th, 18th, 24th months of the tracing program. Experimental results were analyzed by descriptive statistics, independent t-test, and repeated measure ANOVA. The investigators study the above parameter to realize the physiological response to exercise of these patients and discover the appropriate exercise intensity for prescription for EPB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

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

April 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

October 14, 2011

Last Update Submit

May 17, 2019

Conditions

Impaired Oxygen DeliveryIschemic Reperfusion Injury

Keywords

exercise base rehabilitationheart failureperiodic breathingaerobic fitness

Outcome Measures

Primary Outcomes (1)

  • VO2 max(maximal oxygen consumption)

    During cardiopulmonary exercise test, we could measure the value of patients' maximal oxygen consumption. It could represent the functional level of heart failure patient and be the mortality prediction.

    2 years

Secondary Outcomes (2)

  • EPB pattern

    2 years

  • All-cause mortality/CV morbidity

    2 years

Study Arms (2)

Non-EPB

ACTIVE COMPARATOR

with exercise

Behavioral: exercise

EPB with exercise

EXPERIMENTAL

with exercise

Behavioral: exercise

Interventions

exerciseBEHAVIORAL

36 session supervised exercise intervention

Also known as: cardiac rehabilitation
EPB with exerciseNon-EPB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cardiac event with optimal medial treatment within 3 months and have 4 more weeks spared from heart disease attack or major cardiac procedure.

You may not qualify if:

  • unstable angina pectoris
  • uncompensated heart failure
  • myocardial infarction during the past 4 weeks
  • complex ventricular arrhythmias
  • orthopedic or neurological limitations to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

Related Publications (5)

  • Corra U, Pistono M, Mezzani A, Braghiroli A, Giordano A, Lanfranchi P, Bosimini E, Gnemmi M, Giannuzzi P. Sleep and exertional periodic breathing in chronic heart failure: prognostic importance and interdependence. Circulation. 2006 Jan 3;113(1):44-50. doi: 10.1161/CIRCULATIONAHA.105.543173. Epub 2005 Dec 27.

    PMID: 16380551BACKGROUND

  • Bradley TD, Logan AG, Kimoff RJ, Series F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS; CANPAP Investigators. Continuous positive airway pressure for central sleep apnea and heart failure. N Engl J Med. 2005 Nov 10;353(19):2025-33. doi: 10.1056/NEJMoa051001.

    PMID: 16282177BACKGROUND

  • Francis DP, Davies LC, Piepoli M, Rauchhaus M, Ponikowski P, Coats AJ. Origin of oscillatory kinetics of respiratory gas exchange in chronic heart failure. Circulation. 1999 Sep 7;100(10):1065-70. doi: 10.1161/01.cir.100.10.1065.

    PMID: 10477531BACKGROUND

  • Leite JJ, Mansur AJ, de Freitas HF, Chizola PR, Bocchi EA, Terra-Filho M, Neder JA, Lorenzi-Filho G. Periodic breathing during incremental exercise predicts mortality in patients with chronic heart failure evaluated for cardiac transplantation. J Am Coll Cardiol. 2003 Jun 18;41(12):2175-81. doi: 10.1016/s0735-1097(03)00460-1.

    PMID: 12821243BACKGROUND

  • Yajima T, Koike A, Sugimoto K, Miyahara Y, Marumo F, Hiroe M. Mechanism of periodic breathing in patients with cardiovascular disease. Chest. 1994 Jul;106(1):142-6. doi: 10.1378/chest.106.1.142.

    PMID: 8020261BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

ExerciseCardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Tieh-Cheng Fu, M.D

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 18, 2011

Study Start

April 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations

TW(1)