Cardiac Coherence Combined With Personal Physical Activity in Patients With Cancer

NCT03356171 | Completed

• 1 other identifier: 2017/CHU/06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Cancer; Hematologic Diseases

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life

  Health-related quality is assessed by the Quality of Life Questionnaire dedicated to cancer patients and including 30 items (QLQ-C30) developed by the European Organization for Research and Treatment of Cancer (EORTC). This questionnaire is a multimodal construct, typically including physical, emotional and psychological health issues; evaluated with the QLQ-C30 survey of the European Organization for Research and Treatment of Cancer. QLQ-C30 items are coded with the same response categories as items 6 to 28, namely "Not at all", "A little", "Quite a bit" and "Very much." Score ranges from 0 to 100, with higher score indicating higher levels of quality of life.

  on week 12

Secondary Outcomes (3)

• Fatigue improvement

  through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up

• Anxiety and depression improvement with Hospital Anxiety and Depression Scale (HADS) survey

  through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up

• Cardiac coherence improvement

  through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up

Study Arms (2)

Cardiac Coherence

EXPERIMENTAL

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

Procedure: Cardiac Coherence

Adapted Physical Activity

ACTIVE COMPARATOR

Patients only participate to Adapted physical activity sessions

Procedure: Adapted Physical Activity

Interventions

Cardiac Coherence 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.

Cardiac Coherence

Adapted Physical Activity 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.

Adapted Physical Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• months or less since last treatment
• Hemoglobin steady ≥ 90g/L
• In whom APA is prescribed
• Ability to give oral informed consent
• French understanding

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Centre Hospitalier Universitaire de La Réunion

Saint-Pierre, 97410, Reunion

Location

Related Publications (1)

• 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.

  PMID: 32190333 DERIVED

MeSH Terms

Conditions

Motor Activity; Neoplasms; Hematologic Diseases

Condition Hierarchy (Ancestors)

Behavior; Hemic and Lymphatic Diseases

Study Officials

• Quentin CABRERA, MD

  Centre Hospitalier Universitaire de La REUNION, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: November 29, 2017
• Study Start: January 1, 2018
• Primary Completion: October 13, 2023
• Study Completion: April 4, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)