NCT02565771|Completed
Evaluation of the Improvement of Autonomic Nervous System by a Physical Rehabilitation Program Adapted to Adulthood After Chemotherapy or Radiotherapy in Childhood
SALTO_GyV
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SALTO_GyV
Sponsor study identifier
Secondary identifiers
OTHER · ANSM
observational
6
1 country
1
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 30, 2015
Actual (reported)October 1, 2015
Actual (reported)June 2016
Actual (reported)June 2016
Actual (reported)Autonomic nervous system activity
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
Daily activity questionnaire
At 6 months
Quality of Life Questionnaire
At 6 months
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adults treated for childhood cancer in Rhône-Alpes region in France between 1987 and 1992 with deregulation ANS or autonomic imbalance.
CHU de SAINT-ETIENNE
Saint-Etienne, 42000, France
Claire BERGER, MD
CHU de SAINT-ETIENNE
6 participants (actual enrollment reported by the registry).
First Submitted
September 30, 2015
First Posted
October 1, 2015
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Adapted Physical Activity Study
Contact the study team to confirm eligibility.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
July 12, 2016
Record last verified: 2016-07
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Source: ClinicalTrials.gov.
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