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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Pedometer-based physical activity prescription

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36036-110
      • University Hospital of the Federal University of Juiz de Fora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pedometer-based prescription; 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; 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.
No Intervention: Control; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	Exercise capacity will be assessed through the six-minute walking teste.	12 weeks
Asthma Health related quality of life	Asthma Health related quality of life will be assessed through the Asthma Quality of Life Questionnaire.	12 weeks
Asthma Control	Asthma Control will be assessed through the Asthma Control Questionnaire	12 weeks
Depression and anxiety	Depression and anxiety will be assessed through the Hospital Anxiety and Depression Scale	12 weeks
Asthma exacerbations	Asthma exacerbations will be assessed through exacerbation diaries.	12 weeks

Collaborators and Investigators

• Sponsor: Federal University of Juiz de Fora
• Investigators: Study Director: Bruno V Pinheiro, DSc, Federal University of Juiz de Fora; Principal Investigator: Cristina M Coelho, MSc, Federal University of Juiz de Fora

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 8, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (Estimate): November 14, 2013

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Physical Activity; Quality of Life; Pedometers
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 13804413.3.1001.5133