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CompletedNCT02565771SALTO_GyVUpdated Jul 12, 2016

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

An observational study in Cancer, Sequels and Complications, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-12.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer
  • Sequels
  • Complications

Keywords

  • Childhood cancer
  • Cancer
  • Sequels
  • Surgery
  • Complications
  • Chemotherapy
  • Radiotherapy
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In context

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults treated for childhood cancer in Rhône-Alpes region in France between 1987 and 1992 with deregulation ANS or autonomic imbalance.

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

Exclusion Criteria:

  • Written consent form
  • Left ventricular dysfunction
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Adapted physical activity

Interventions

  • OtherAdapted physical activity

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: At 6 months

Secondary outcomes

  1. Daily activity questionnaire

    Time frame: At 6 months

  2. Quality of Life Questionnaire

    Time frame: At 6 months

07

Study locations

1 site
  • CHU de SAINT-ETIENNE
    Saint-etienne, 42000, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02565771
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Oct 1, 2015
Start date
Mar 2013
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jul 12, 2016

Study contacts

Claire BERGER, MD
principal investigator · CHU de SAINT-ETIENNE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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