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Physical ActivityAPACCHENCT03356171

Cardiac Coherence Combined With Personal Physical Activity in Patients With Cancer

A study testing Cardiac Coherence and Adapted Physical Activity in people with Physical Activity and Cancer, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Physical Activity, Cancer, Hematologic Diseases
What is being tested?
Cardiac Coherence and Adapted Physical Activity
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteReunion
Study dates
1 Jan 2018to 4 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • In whom APA is prescribed
  • Ability to give oral informed consent
  • French understanding

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Reunion1 site

  • Centre Hospitalier Universitaire de La Réunion

    Saint-Pierre, 97410

Other trials in Reunion

About this study

Official title: Combination of Cardiac Coherence to Physical Activity

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.

Read the 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).

Being tested
Cardiac Coherence, Adapted Physical Activity
Medical subject headings
Motor Activity, Neoplasms, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac CoherenceProcedure or surgery

    • 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 ActivityProcedure or surgery

    • 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.
Study groups in NCT03356171
Study groupRoleWhat they receive
Cardiac CoherenceExperimentalPatients participate to Adapted physical activity sessions and to cardiac coherence sessions
Receives: Procedure: Cardiac Coherence
Adapted Physical ActivityActive comparatorPatients only participate to Adapted physical activity sessions
Receives: Procedure: Adapted Physical Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: on week 12

Secondary outcomes (3)

  1. Fatigue improvement

    Fatigue improvement is assessed by multidimensional fatigue inventory (MFI-20 survey).

    MFI-20 consists of five subscales used to express: general fatigue, physical, reduced activities, reduced motivation, mental fatigue.

    Each scale contains four items for which the person had to indicate the extent the items describe their situations in the recent few days on a 5-point Likert scale, ranging from "yes, that is true" to "no, that is not true" Scores on each subscale range from 4 to 20, with higher scores indicating higher levels of fatigue.

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

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

    Anxiety and depression improvement is assessed by HADS survey. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3: a person can score between 0 and 21 for either anxiety or depression.

    Higher scores indicate higher levels of depression or anxiety

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

  3. Cardiac coherence improvement

    Increased percentage of cardiac coherence is measured with SYMBIOLINE software

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2017
  2. Study start1 Jan 2018
  3. Primary completion13 Oct 2023
  4. Study completion4 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03356171
Sponsor's protocol ID
2017/CHU/06
Acronym
APACCHE
Status last verified
Sep 2025
First submitted
23 Nov 2017
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32190333

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac Coherence and Adapted Physical Activity in people with Physical Activity and Cancer, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life (time frame: on week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03356171, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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