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

Completed

• Conditions: Cancer; Sequels; Complications

• Registration Number: NCT02565771
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Autonomic nervous system activity	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 Outcome Measures

Name	Time	Method
Quality of Life Questionnaire	At 6 months
Daily activity questionnaire	At 6 months

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France