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Completed

NCT Number: NCT02565771

Evaluation of the Improvement of Autonomic Nervous System by a Physical Rehabilitation Program Adapted to Adulthood After Chemotherapy or Radiotherapy in Childhood

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.

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Key information

Conditions

Cancer Complications Neoplasms Sequels

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

About this study

The main objective of this study is to evaluate improvement of ANS parameters after 6 months of adapted physical activity in adults treated for childhood cancer in Rhône-alpes region in France who have deregulation ANS or autonomic imbalance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adapted physical activity

Other

The adapted physical activity is done by Education Physique et Gymnastique Volontaire (EPGV) centres.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Daily activity questionnaire

    Time frame: At 6 months

  2. Quality of Life Questionnaire

    Time frame: At 6 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: SALTO_GyV

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 1, 2015
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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