The objective of the study is to investigate if respiratory feedback training as an additional rehabilitation method after acute myocardial infarction might improve quality of live Primary objective: Is quality of live as measured by the "Heart…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The sumscore of the Spielburger state-trait anxiety inventory (STAI)
Secondary outcome
Time domain parameters for heart rate variability.
Mean heart rate (beats/min)
Mean RR tijdintervals (ms)
Standard deviation RR intervals (ms)
Standaard deviation of successive RR interval differences, RMSSD (ms).
Number of successive intervals differing more than 50 ms express as an
percentage (pNN50).
Frequency domain parameters for heart rate variability.
Integrated power in the low frequency (LF) band (0.04 -0.15 Hz).
Integrated power in the high frequency (HF) band (0.15 - 0.4 Hz).
The ratio between Lf an HF band powers powers (L/H ratio).
The QT interval
Background summary
Respiratory bio feedback training as an additional rehabilitation method for
patients after an acute ST elevated myocardial infarction with primary coronair
intervention in the acute phase.
Mental stress is common in patients with coronary heart disease and is a risk
factor for cardiac morbidity and mortality. Depression is associated with
autonomic nervous system dysfunction, which may at least partially explain this
increased risk (1).
The autonomuc nervous system activity is increased after myocard infarction
characterized by sympathetic hyperactivity and reduced vagal activity (2.3,4).
Biofeedback is a self-regulating therapy in which the patient can influence the
activity of its own autonomic nervous system. Up to the fifties scientists
believed that autonomic funtions such as digestion, blood pressure, and body
temperature could not be self controled. However, after the fifties it became
clear that
the input of the autonomic nervous system can be regulated by mindfulness and
training (5). Heart rate variability describes the variations between
consecutive heartbeats and can be used to reflect sympatho-vagal balance.
This non invasive measurement of the autonomic nervous activity gives
information about vagal modulation and symphatovagal interaction. In particular
HRV depends on extrinsic heart rate regulation and reflects the ability of the
heart to adapt fast to non-predictable circumstances (6). Reduced heart rate
variability is associated with poor prognostics after myocardial infarction
(3,6). Heart rate variability can be increased by respiratory biofeedback
training (5). Only little is known about the effect size of respiratory
feedback training in patients with acute myocardial infarct and PCI.QT Interval
variability will be determined during exercise as a measure of autonomic
activity.
The objective of the study is to investigate the use of respiratory feedback
training as a means of stress management to improve prognosis after an acute ST
elevated myocardinal infarction with primary coronair intervention in the acute
phase.
Literature
1)
R.M. Carney, K.E. Freeland. Depression and heart rate variability in patients
with coronary heart disease, Cleveland Clinic Journal of Medicine (2009)
76:S13-17.
2)
G. R. H. Sandercock, R. Grocott-Mason, D. A. Brodie, Changes in short-term
measures of heart rate variability after eight weeks of cardiac
rehabilitation, Clin Auton Res (2007) 17:39-45.
3)
M. Quintana, N. Storckf, L. E. Lindbladf, K. Lindvall and M. Ericson, Heart
rate variability as a means of assessing prognosis after acute myocardial
infarction, a 3-year follow-up study, European Heart Journal (1997) 18, 789-797.
4)
Balanescu S, Corlan A, Dorobantu M, Gherasim L (2004) Prognostic value of heart
rate variability after acute myocardial infaction. Med Sci Monit, 10:CR307-
CR315.
5)
C. S. Moravec, Biofeedback therapy in cardiovascular disease: Rationale and
research overview, Cleveland Clinic Journal Of Medicine (2008) 75 S35-S38.
6)
U. R. Acharya, K. P. Joseph , N. Kannathal, C. Min Lim, J. S. Suri, Heart rate
variability: a review, Med Bio Eng Comput (2006) 44:1031-1051.
7)
N. Singh, D. Mironov, P.W. Armstrong, A. M. Ross, A. Langer,for the GUSTO ECG
Substudy Investigators, Heart Rate Variability Assessment Early After Acute
Myocardial Infarction, Circulation. 1996;93:1388-1395.
Study objective
The objective of the study is to investigate if respiratory feedback training
as an additional rehabilitation method after acute myocardial infarction might
improve quality of live
Primary objective:
Is quality of live as measured by the "Heart Patients Psychological
Questionaire (HPPQ) at the end of rehabilitation and one year after myocardial
infarction and Percutaneous Coronary Intervention (PCI) more improved in the
intervention group compared to the non intervantion group.
secondarily objective:
Are heart rate variability parameters in the intervention- and non intervention
group different from each other at the end of the rehabilitation period and
one year after myocardial infarction.
Study design
Prospective randomized case control trial matched for gender and age.
Study burden and risks
The burden for the intervention group is 30 minutes coaching a week and 5
minutes daily training. It is anticipated that coaching and training will be
appreciated. If not the patient is free to end the program any time he or she
would like to be. The burden for both the intervention and non-intervention
group is to fill in the STAI questionnaire at intake and after one year. It is
considered that the program is free of any risk.
Postbus 9100
6500 HB Nijmegen
NL
Postbus 9100
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Patients with ST elavated myocardial infarct treated with primary PTCA in the acute phase.
age 40-70 years old
good Dutch understanding and writing
Exclusion criteria
Patients who do not participate in the standard revalidation program.
younger than 40 years
older than 70 years
patients unable to speak or write Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28092.091.09 |