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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT02565771

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Sequels Complications	Other: Adapted physical 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 Design

Study Type:

Observational

Actual Enrollment :

6 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

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

Daily activity questionnaire [At 6 months]
Quality of Life Questionnaire [At 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de SAINT-ETIENNE	Saint-etienne		France	42000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: Claire BERGER, MD, CHU de SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT02565771

Other Study ID Numbers:

1208137
2012-A01220-43

First Posted:

Oct 1, 2015

Last Update Posted:

Jul 12, 2016

Last Verified:

Jul 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Study Results

No Results Posted as of Jul 12, 2016