- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02565771
Evaluation of the Improvement of Autonomic Nervous System by a Physical Rehabilitation Program Adapted to Adulthood After Chemotherapy or Radiotherapy in Childhood (SALTO_GyV)
Survival rate of childhood cancers is now reaching 80%. However, early or late complications related to surgery, chemotherapy and radiotherapy remain high and greatly increase the risk of late mortality.
Health of individuals is closely correlated to the stability of the autonomic nervous system (ANS), a key system for maintaining homeostasis in any living species. Efficient computer tools allowed the opportunity to assess the intrinsic autonomic regulation of the ANS either directly or at a later time by an analysis of the heart rate variability (HRV). These tools have become very powerful predictors of cardiovascular morbidity and neurological aging. Physical endurance training improves both maximal aerobic capacity and ANS activity.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Saint-etienne, France, 42000
- CHU de Saint-Etienne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Included in the SALTO_SNA study (NCT01574196)
- Alteration of the autonomic nervous system activity or deregulation of the sympatho-vagal balance
Exclusion Criteria:
- Written consent form
- Left ventricular dysfunction
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Young adult survivors of childhood cancer
Adults treated for childhood cancer in Rhône-Alpes region in France between 1987 and 1992 with deregulation ANS or autonomic imbalance.
|
The adapted physical activity is done by Education Physique et Gymnastique Volontaire (EPGV) centres.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autonomic nervous system activity
Time Frame: At 6 months
|
The autonomic nervous system activity is classified in sympatho-vagal equilibrium as "normal", "altered" or "severely abnormal". For this classification, we need the values obtained for some temporal indices (Standard Deviation NN intervals (SDNN), Root Mean Square of Successive Differences (RMSSD)) and frequencies (Ptot, High Frequency (HF), Low Frequency (LF) , Very-Low Frequency (VLF), ratio LF / HF) compared to validated standards for the age (mean +/- standard deviation). |
At 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Daily activity questionnaire
Time Frame: At 6 months
|
At 6 months
|
Quality of Life Questionnaire
Time Frame: At 6 months
|
At 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Claire BERGER, MD, CHU de Saint-Etienne
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1208137
- 2012-A01220-43 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
Clinical Trials on Adapted physical activity
-
Assistance Publique Hopitaux De MarseilleNot yet recruiting
-
University Hospital, CaenNot yet recruitingChronic Pain | Multiple Myeloma | Adapted Physical Activity
-
Central Hospital, Nancy, FranceRecruiting
-
WepromRecruitingLymphoma | Myeloma | Autologous TransplantFrance
-
Centre Hospitalier Universitaire de NiceCompleted
-
Support and Education Technic CentreCompletedHeart Failure | Cardiovasculars Risk FactorsFrance, Cameroon
-
University of LausanneCompletedPostural ControlSwitzerland
-
University Hospital, AngersNot yet recruitingCardio-Respiratory FailureFrance
-
Mon Stade Sports Medicine CentreLaboratory MOVE, Faculty of Sport Sciences, University of Poitiers, France; Public Health Foundation of MGEN, France and other collaboratorsRecruitingPhysical Activity | Life Style, Healthy | Adherence, Patient | Life Style | Cost-Benefit Analysis | Behavior and Behavior Mechanisms | Exercise Therapy | Adapted Physical Activity | Lifestyle, Sedentary | PrescriptionsFrance
-
Centre Hospitalier Universitaire de NiceCompleted