Text Size

Effects of Training in Healthy Sedentary Subjects

This study has been completed.
Sponsor:
Collaborators:
Centre Hospitalier Régional Universitaire Montpellier
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Groupe Fontalvie
ClinicalTrials.gov Identifier:
NCT01183039
First received: August 16, 2010
Last updated: September 3, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to understand underlying mechanisms of improved exercise tolerance in Healthy Sedentary Subjects after training program.


Condition Intervention
Sedentary Subjects
 Other: Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Cellular Effects of Training in Healthy Sedentary Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Groupe Fontalvie:

Primary Outcome Measures:
  • Effects of training program on mitochondrial function and oxidative stress [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between mitochondrial function, oxidative stress and exercise tolerance in COPD patients [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ventilatory threshold
Training at the ventilatory threshold
 Other: Training
20 sessions of training
Other Names:
  • Vt
  • Mt
Active Comparator: Metabolic threshold
Training at the metabolic threshold
 Other: Training
20 sessions of training
Other Names:
  • Vt
  • Mt

Detailed Description:

Training protocol used is based on recommendations. A minimum of 20 sessions in 4-6 weeks were proposed. The exercise intensity of exercise corresponds to target heart rate at ventilatory threshold measured during incremental exercise test. Training at this intensity allowed us to individualize effort for each patient.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • healthy Sedentary Subjects

Exclusion Criteria:

  • neuromuscular disease
  • chronic heart failure
  • diabetes
  • renal diseases
  • liver diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183039

Locations
France
Clinique du souffle La valonie
Lodeve, France
hopital Arnaud de Vilneuve
Montpellier, France
Clinique du souffle La solane
Osseja, France
Sponsors and Collaborators
Groupe Fontalvie
Centre Hospitalier Régional Universitaire Montpellier
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Maurice MH Hayot, MCU-PH Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Groupe Fontalvie
ClinicalTrials.gov Identifier: NCT01183039     History of Changes
Other Study ID Numbers: 2008-A00209-46
Study First Received: August 16, 2010
Last Updated: September 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Fontalvie:
Sedentary

ClinicalTrials.gov processed this record on October 17, 2012