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Relaxation with heart: Short- and medium-term effects of autogenic training on psychological and psychobiological stress indicators in chronic heart failure

Relaxation with heart: Short- and medium-term effects of autogenic training on psychological and psychobiological stress indicators in chronic heart failure - Relaxation with heart

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023810
Enrollment
36
Registered
2021-01-21
Start date
2020-12-03
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50.12 I50.13

Interventions

Group 1: The autogenic training extends over 8 weeks with 1 group session per week (length: 30-40 minutes). Each intervention group consists of 2-3 patients and 1 course instructor. The intervention

Sponsors

Universität Trier, Fachbereich I - Pflegewissenschaft, Abteilung für Gesundheitspsychologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: • Age between 18 and 85 years (typical age cohort in systolic HI studies) • Diagnosis of chronic systolic dysfunction (LVEF <40%, diagnosed via echocardiography) • The underlying disease is a dilated cardiomyopathy, ischemic heart disease or hypertensive heart failure • NYHA Class II or III or Stage C of the ACC / AHA classification • Intrinsic sinus rhythm • subjectl understand the principle of the study and has the physical, psychological and cognitive requirements for learning AT and gives written consent.

Exclusion criteria

Exclusion criteria: • Diagnosed heart failure with preserved ejection fraction • Atrial fibrillation and chronotropic incompetence • Myocarditis in the past six months • Alcohol or drug abuse in the past six months • Currently severe symptomatic heart valve stenosis or regurgitation • Unstable angina pectoris • Chronic renal failure • Diagnosis of a mental disorder (F48.1, F44.x) • Gastrointestinal disorder (K27, K28 and K92), because activation of the solar plexus by AT promotes blood flow to the tissues • Implanted mechanical cardiac assist system • Treatment with anti-TNF therapy, for example for rheumatism or psoriasis • Other serious illness (e.g. advanced cancer) • Lack of German language skills. • The screening for AT (anamnesis sheet AT-ANAM) provides indications of contraindications and lack of motivation that lead to exclusion.

Design outcomes

Primary

MeasureTime frame
Changes in objectively recorded stress markers from T1 to T2 and to T3 willl be examined as primary outcomes. 1) Changes in blood pressure and autonomic nervous system: · Systolic and diastolic blood pressure, pulse · Plasma adrenaline / noradrenaline concentrations. The blood samples are taken i the supine position after a 10-minute habituation period in order to avoid a significant increase in the catecholamine concentration. · Alpha-amylase in saliva, determined as a morning and day profile on two consecutive days with a total of 14 measurement times. 2) Changes in the activation of the HPA axis: · Salivary cortisol, determined as a morning and day profile (cortisol awakening response with 4 samples in the morning: +1, +15, +30, +60 min, additionally one sample at 11 a.m., 3 p.m. and 8 p.m.). In order to obtain stable values, the measurement is repeated on the following day, so that a total of 14 measurement times result. MemsCaps are used to control when the samples were taken. 3) Changes in inflammatory markers: · Plasma concentrations of the proinflammatory cytokines TNF-a and interleukin-6 · Plasma concentrations of the anti-inflammatory cytokine IL-10

Secondary

MeasureTime frame
Secundary outcomes will be changes in the subjective stress levels from T1 to T2 and to T3 by established standardized measurement instruments. · Stressors and stress levels (Trier inventory of chronic stress; TICS) · Symptoms and complaint burden (change-sensitive symptom list on relaxation experience, well-being, complaint and symptom burden; ASS-SYM) · State and trait depression and state and trait anxiety (State-Trait-Anxiety-Depression Inventory; STADI) · Self-reported coping (stress management questionnaire; SVF 120-S) In addition, changes in indicators of disease severity from T1 to T2 and to T3 will be recorded as exploratory outcomes: · Plasma concentration of the N-terminal pro brain natriuretic peptide (NT-proBNP) · 6-minutes walking distance

Countries

Germany

Contacts

Public ContactTara Partetzke

Universität Trier, Fachbereich I - Pflegewissenschaft, Abteilung für Diagnostik in der Gesundheitsversorgung & E-Health

partetz@uni-trier.de+49 (0)651 / 201 - 3870

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026