NCT00820716

Brief Summary

The aim of the study is to compare two methods of exercise training: alternate load versus constant load realized at moderate or high intensities, in order to define the interests and the limits of each one of these two methods. The finality is to make possible to the expert to choose what exercise training induces the best results quickly and to make its choice according to the therapeutic objectives which it lays down.We also evaluate the effects of these exercises training on the vagal response and the bronchial tone of the asthmatics. From a clinical point of view, a close attention will be paid to the effects of these exercises training on the control of asthma and the quality of life of the subjects

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

September 21, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2010

Completed
Last Updated

July 14, 2020

Status Verified

August 1, 2011

Enrollment Period

1.1 years

First QC Date

January 9, 2009

Last Update Submit

July 9, 2020

Conditions

Keywords

AsthmaAsthmatic subjectsExercise trainingConstant loadAlternate load

Outcome Measures

Primary Outcomes (2)

  • Maximal oxygen consumption (VO2max)

    At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training

  • Maximal power output (Pmax)

    At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training

Secondary Outcomes (3)

  • Exhaled NO (eNO)

    At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training

  • Heart rate variability

    At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training

  • Force Expiratory Volume in one second (FEV1)

    At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training

Study Arms (2)

CA

EXPERIMENTAL

Exercise training with alternate load

Other: Exercise training

CC

ACTIVE COMPARATOR

Exercise training with constant load

Other: Exercise training

Interventions

Comparison of two methods of exercise training: alternate load versus constant load realized at moderate or high intensities

CACC

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 45 years old
  • mild to moderate persistent asthma (GINA classification)
  • stabilized asthma
  • physical activity level between 5 and 11 (Baecke and coll, 1982)
  • no contra-indication for physical training

You may not qualify if:

  • cardiovascular pathology
  • metabolic pathology
  • traumatic pathology
  • BMI≥30
  • tobacco
  • diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de Physiologie et d'Explorations Fonctionnelles - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil

Strasbourg, 67 091, France

Location

Service de Pneumologie - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Asthma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Evelyne LONSDORFER, MD

    Hôpitaux Universitaires de Strasbourg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 12, 2009

Study Start

September 21, 2009

Primary Completion

October 15, 2010

Study Completion

October 15, 2010

Last Updated

July 14, 2020

Record last verified: 2011-08

Locations