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Clinical Trial Summary

APACCHE (Adapted Physical Activity and Cardiac Coherence in HEmatologic patients) study investigates effects of heart rate variability biofeedback training, combined with classical adapted physical activity, on health-related quality of life in patients previously treated for hematologic malignancies. It is a prospective, randomized clinical trial from University Hospital of Reunion Island. The main objective is evaluated with QLQ-C30 survey score differences.

Clinical Trial Description

Hematologic malignancies are aggressive cancers with significant long-term effects on physical and psychological health, due to the disease itself or aggressive treatments. Physical activity, with specific treatments, improves physical and psychological health in solid tumors patients. However, in hematologic malignancies, there is unsatisfactory quality of evidence that physical activity alone improves the various dimensions of quality of life.

Recent studies on heart-brain connections suggest that a high level of coherence in the heart rate variability may induce psychophysiological positive effects. Cardiac coherence is reached when the heart rhythm pattern becomes sine-wave-like at a frequency around 0.1 Hz. This status can be increased by the mean of deep and slow breathing control and/or positive emotions. By using a heart rate variability biofeedback training, previous studies have shown effects on physiological variables such as reduction of blood pressure or increase of vagal heart rate control, and also on psychological variables such as reduction of stress, anxiety, and depression.

The APACCHE protocol investigate if cardiac coherence biofeedback training, associated with an adapted physical activity program, can improve health related quality of life in adult hematologic patients.

70 patients are randomly assigned to receive either ten sessions of cardiac coherence biofeedback (CC-BF) and the adapted physical activity program (APA) or just APA. Both interventions are conducted simultaneously over 12 weeks, with 10 sessions of CC-BF (45mn) weekly and 24 sessions of APA (1h30) bi-weekly.

Data are collected at enrollment(T1), at 6 weeks (T2), at intervention ending at 12 weeks (T3) and after a 24 weeks follow-up (T4). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03356171
Study type Interventional
Source Centre Hospitalier Universitaire de la Réunion
Contact Christine JUHEL, PHD
Phone +262262359949
Status Not yet recruiting
Phase N/A
Start date January 2018
Completion date June 2019

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