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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02565771
Acronym
SALTO_GyV
Enrollment
6
Registered
2015-10-01
Start date
2013-03-31
Completion date
2016-06-30
Last updated
2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Complications, Sequels

Keywords

Childhood cancer, Cancer, Sequels, Surgery, Complications, Chemotherapy, Radiotherapy

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.

Interventions

OTHERAdapted physical activity

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Autonomic nervous system activityAt 6 monthsThe 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

MeasureTime frame
Daily activity questionnaireAt 6 months
Quality of Life QuestionnaireAt 6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026