Clinical trial NCT03356171: Cardiac Coherence Combined With Personal Physical Activity in Patients With Cancer
Official title: Combination of Cardiac Coherence to Physical Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Cancer
Hematologic Diseases
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* All patients, previously treated and in remission for an Hematologic malignancy, in whom APA is indicated.
* Adult patients aged 18-65 yo
* Followed at South University Hospital of La Réunion Island
* Previously treated for Hematologic Malignancy, and in Remission (complete or partial)
* 6 months or less since last treatment
* Hemoglobin steady ≥ 90g/L
* In whom APA is prescribed
* Ability to give oral informed consent
* French understanding

Exclusion Criteria:

* With contraindication for APA
* Under anti-arhythmic or beta-blocker drugs
* Cardiac insufficiency (Left ventriculi Ejection Fraction less than 40%)
* Participation in another trial

Primary outcomes:
measure: Health-related quality of life
timeFrame: on week 12
Secondary outcomes:
measure: Fatigue improvement
timeFrame: through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up
measure: Anxiety and depression improvement with Hospital Anxiety and Depression Scale (HADS) survey
timeFrame: through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up
measure: Cardiac coherence improvement
timeFrame: through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hpospitalier Universitaire de La REUNION
name: Quentin CABRERA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fournie C, Bouscaren N, Dalleau G, Lenclume V, Mohr C, Zunic P, Cabrera Q, Verkindt C. Adapted physical activity and cardiac coherence in hematologic patients (APACCHE): study protocol for a randomized controlled trial. BMC Sports Sci Med Rehabil. 2020 Mar 14;12:18. doi: 10.1186/s13102-020-00170-3. eCollection 2020.