Cardiac Coherence Combined With Personal Physical Activity in Patients With Cancer

NCT ID: NCT03356171

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2024-04-04

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).

Conditions

Physical Activity; Cancer; Hematologic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Cardiac Coherence

Patients participate to Adapted physical activity sessions and to cardiac coherence sessions

Group Type: EXPERIMENTAL

Cardiac Coherence

Intervention Type: PROCEDURE

• 10 sessions of HRV-BF (45mn) weekly over 12 weeks. HRV-BF is a cognitive behavioural therapy consisting on stress management training based on breathing. We use the SYMBIOLINE PC software to record the heart rate variability biofeedback, with an infrared plethysmograph sensor. The sensor is put on the finger, and the patient's HRV pattern is displayed in real time.
• 24 APA sessions (1.5h) bi-weekly over 12 weeks. Each session includes aerobic exercises (walk, step) and resistant exercises (muscular reinforcement). This program is built on previous cancer studies to make it effective.

Adapted Physical Activity

Patients only participate to Adapted physical activity sessions

Group Type: ACTIVE_COMPARATOR

Adapted Physical Activity

Intervention Type: PROCEDURE

\- 24 APA sessions (1.5h) bi-weekly over 12 weeks. Each session includes aerobic exercises (walk, step) and resistant exercises (muscular reinforcement). This program is built on previous cancer studies to make it effective.

Interventions

Cardiac Coherence

• 10 sessions of HRV-BF (45mn) weekly over 12 weeks. HRV-BF is a cognitive behavioural therapy consisting on stress management training based on breathing. We use the SYMBIOLINE PC software to record the heart rate variability biofeedback, with an infrared plethysmograph sensor. The sensor is put on the finger, and the patient's HRV pattern is displayed in real time.
• 24 APA sessions (1.5h) bi-weekly over 12 weeks. Each session includes aerobic exercises (walk, step) and resistant exercises (muscular reinforcement). This program is built on previous cancer studies to make it effective.

Intervention Type: PROCEDURE

Adapted Physical Activity

\- 24 APA sessions (1.5h) bi-weekly over 12 weeks. Each session includes aerobic exercises (walk, step) and resistant exercises (muscular reinforcement). This program is built on previous cancer studies to make it effective.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quentin CABRERA, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de La REUNION, France

Locations

Centre Hospitalier Universitaire de La Réunion

Saint-Pierre, , Reunion

Countries

Reunion

References

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.

Reference Type: DERIVED

PMID: 32190333 (View on PubMed)

Other Identifiers

2017/CHU/06

Identifier Type: -

Identifier Source: org_study_id