NCT00989365

Brief Summary

The investigators hypothesize that aerobic training can reduce anxiety, depression and airway inflammation and those benefits may be related to changes in autonomic system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
Last Updated

October 5, 2009

Status Verified

October 1, 2009

Enrollment Period

2.7 years

First QC Date

October 2, 2009

Last Update Submit

October 2, 2009

Conditions

AnxietyDepressionAirway Inflammation

Keywords

Aerobic ExerciseExercise

Outcome Measures

Primary Outcomes (1)

  • psychosocial morbidity and airway inflammation

    3 months

Secondary Outcomes (1)

  • autonomic modulation, aerobic capacity, pulmonary function

    3 months

Study Arms (1)

Patient cousenling

OTHER

Improve medicine use Self control asthma crisis Ambient hygiene

Other: Aerobic training

Interventions

Aerobic trainingOTHER

Treadmill training

Also known as: Exercise conditioning
Patient cousenling

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • moderate and severe asthma

You may not qualify if:

  • other pulmonary or cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital, School of Medicine, University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (2)

  • Fanelli A, Cabral AL, Neder JA, Martins MA, Carvalho CR. Exercise training on disease control and quality of life in asthmatic children. Med Sci Sports Exerc. 2007 Sep;39(9):1474-80. doi: 10.1249/mss.0b013e3180d099ad.

    PMID: 17805077BACKGROUND

  • Mendes FA, Goncalves RC, Nunes MP, Saraiva-Romanholo BM, Cukier A, Stelmach R, Jacob-Filho W, Martins MA, Carvalho CR. Effects of aerobic training on psychosocial morbidity and symptoms in patients with asthma: a randomized clinical trial. Chest. 2010 Aug;138(2):331-7. doi: 10.1378/chest.09-2389. Epub 2010 Apr 2.

    PMID: 20363839DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepressionMotor Activity

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Celso RF Carvalho, PhD

    School of Medicine, University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 5, 2009

Study Start

January 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 5, 2009

Record last verified: 2009-10

Locations

BR(1)