Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    apacche
Previous Study | Return to List | Next Study

Cardiac Coherence Combined With Personal Physical Activity in Patients With Cancer (APACCHE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03356171
Recruitment Status : Unknown
Verified December 2017 by Centre Hospitalier Universitaire de la Réunion.
Recruitment status was:  Not yet recruiting
First Posted : November 29, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Tracking Information
First Submitted Date  ICMJE November 23, 2017
First Posted Date  ICMJE November 29, 2017
Last Update Posted Date December 19, 2017
Estimated Study Start Date  ICMJE January 2018
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
Health-related quality of life [ Time Frame: on week 12 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2017)
Health-related quality of life [ Time Frame: on wekk 12 ]
Health-related quality is assessed by the Quality of Life Questionnaire 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
  • Fatigue improvement [ Time Frame: through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up ]
    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.
  • Anxiety and depression improvement with Hospital Anxiety and Depression Scale (HADS) survey [ Time Frame: through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up ]
    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
  • Cardiac coherence improvement [ Time Frame: through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up ]
    Increased percentage of cardiac coherence is measured with SYMBIOLINE software
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2017)
  • Fatigue improvement [ Time Frame: through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up ]
    Fatigue improvement is assessed by MFI-20 survey
  • Anxiety and depression improvement with HADS survey [ Time Frame: through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up ]
    Anxiety and depression improvement is assessed by HADS survey
  • Cardiac coherence improvement [ Time Frame: through study completion: initially (T1), at 6 weeks (T2), 12 weeks (T3) and after at 24 weeks (T4) follow-up ]
    Increased percentage of cardiac coherence is measured with SYMBIOLINE software
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiac Coherence Combined With Personal Physical Activity in Patients With Cancer
Official Title  ICMJE Combination of Cardiac Coherence to Physical Activity
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Physical Activity
  • Cancer
  • Hematologic Diseases
Intervention  ICMJE
  • Procedure: 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Cardiac Coherence
    Patients participate to Adapted physical activity sessions and to cardiac coherence sessions
    Intervention: Procedure: Cardiac Coherence
  • Active Comparator: Adapted Physical Activity
    Patients only participate to Adapted physical activity sessions
    Intervention: Procedure: Adapted Physical Activity
Publications * Fournié 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 23, 2017)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03356171
Other Study ID Numbers  ICMJE 2017/CHU/06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de la Réunion
Study Sponsor  ICMJE Centre Hospitalier Universitaire de la Réunion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Quentin CABRERA, MD Centre Hpospitalier Universitaire de La REUNION
PRS Account Centre Hospitalier Universitaire de la Réunion
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP