Clinical Trials Logo
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

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

See also
  Status Clinical Trial Phase
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Active, not recruiting NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development N/A
Recruiting NCT03167372 - Pilot N-of-1 Light Therapy Study N/A
Recruiting NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Completed NCT01077414 - Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness N/A
Enrolling by invitation NCT02565004 - Clinical and Laboratory Analysis of Familial Cancer N/A
Completed NCT01340846 - A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors Phase 1
Active, not recruiting NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center N/A
Recruiting NCT03247309 - TCR-engineered T Cells in NSCLC and HNSCC Patients (ACTengine) Phase 1
Active, not recruiting NCT00587886 - Estrogen, Diet, Genetics and Endometrial Cancer N/A
Active, not recruiting NCT00984035 - Investigation of Cisplatin-Related Kidney Toxicity N/A
Not yet recruiting NCT03257969 - Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients With Risk Factors N/A
Recruiting NCT02869802 - Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis N/A
Recruiting NCT02839889 - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation) Phase 4
Recruiting NCT02883699 - Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study N/A
Active, not recruiting NCT02891993 - Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer N/A
Recruiting NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Recruiting NCT02765451 - Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU) N/A