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OpenTrials
Completed

NCT Number: NCT01984281

Effects of a Pedometer-based Unsupervised Exercise Program Upon Lifestyle Physical Activity of Asthmatic Adults

The purpose of this study is to determine whether a pedometer-based unsupervised exercise program is more effective than a general exercise recommendation to increase lifestyle physical activity in adult patients with asthma.

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Key information

Conditions

Asthma Behavior Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of the Federal University of Juiz de Fora

Juiz de Fora, Minas Gerais, 36036-110, Brazil

About this study

The patients will be randomized in two groups: the intervention group will receive a standardized advice to physical activity practice plus pedometers and step goals to achieve over the next twelve weeks and the control group will receive the same standardized advice to physical activity practice and usual care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Asthma diagnosis for at least 6 months (according to Global Initiative for Asthma criteria)
  • Regular drug therapy (inhaled corticosteroids or inhaled corticosteroids plus long-acting beta-agonists)
  • Clinical stability during the run-in period (3 weeks)

Exclusion criteria

  • Physical activity practice over once a week
  • Disabling musculoskeletal disease
  • Cardiopathy
  • Other lung disease
  • More than 10 pack-years of smoking
  • Pregnancy
  • Refusal to participate

Treatment and study plan

Pedometer-based physical activity prescription

Behavioral

After baseline assessments, both groups will receive a educational session, regarding important aspects of asthma plus a unsupervised exercise prescription (walking, 5 times per week, for at least 30 minutes). Only the experimental group will receive a pedometer-based physical activity prescription, consisting of targets (steps per day) to be achieved. The initial target will be determined based on the average of steps per day assessed during the baseline assessments plus 1000 steps. The targets will be biweekly. Both groups will be contact once a week (by phone) and will be asked to return for asthma control assessments once a month.

Primary outcomes

  1. Lifestyle physical activity

    Time frame: 12 weeks

    The lifestyle physical activity will be estimated as the mean number of steps taken in six days using a pedometer (SW200, YAMAX,Tokyo, Japan)

Secondary outcomes

  1. Exercise capacity

    Time frame: 12 weeks

    Exercise capacity will be assessed through the six-minute walking teste.

  2. Asthma Health related quality of life

    Time frame: 12 weeks

    Asthma Health related quality of life will be assessed through the Asthma Quality of Life Questionnaire.

  3. Asthma Control

    Time frame: 12 weeks

    Asthma Control will be assessed through the Asthma Control Questionnaire

  4. Depression and anxiety

    Time frame: 12 weeks

    Depression and anxiety will be assessed through the Hospital Anxiety and Depression Scale

  5. Asthma exacerbations

    Time frame: 12 weeks

    Asthma exacerbations will be assessed through exacerbation diaries.

Sponsors and collaborators

Lead sponsor

Federal University of Juiz de Fora

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 14, 2013
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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