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

NCT01984281 | Completed

• 1 other identifier: 13804413.3.1001.5133
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Physical Activity; Pedometers; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Lifestyle physical activity

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

  12 weeks

Secondary Outcomes (5)

• Exercise capacity

  12 weeks

• Asthma Health related quality of life

  12 weeks

• Asthma Control

  12 weeks

• Depression and anxiety

  12 weeks

• Asthma exacerbations

  12 weeks

Study Arms (2)

Pedometer-based prescription

EXPERIMENTAL

After baseline assessments, the control group will receive a educational session, regarding important aspects of asthma (symptoms, treatment, exacerbations, triggers, etc) plus a unsupervised exercise prescription (walking, 5 times per week, for at least 30 minutes) and a pedometer-based physical activity prescription, consisting of targets to be achieved (in terms of steps per day).

Behavioral: Pedometer-based physical activity prescription

Control

NO INTERVENTION

After baseline assessments, the control group will receive a educational session, regarding important aspects of asthma (symptoms, treatment, exacerbations, triggers, etc) plus a unsupervised exercise prescription (walking, 5 times per week, for at least 30 minutes).

Interventions

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.

Pedometer-based prescription

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead

Study Sites (1)

University Hospital of the Federal University of Juiz de Fora

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

Location

MeSH Terms

Conditions

Asthma; Motor Activity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Study Officials

• Bruno V Pinheiro, DSc

  Federal University of Juiz de Fora

  STUDY DIRECTOR

• Cristina M Coelho, MSc

  Federal University of Juiz de Fora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 14, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

BR (1)