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

NCT ID: NCT01984281

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Pedometer-based physical activity prescription

Intervention Type: 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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Juiz de Fora

OTHER

Sponsor Role: lead

Responsible Party

Cristina Martins Coelho

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruno V Pinheiro, DSc

Role: STUDY_DIRECTOR

Federal University of Juiz de Fora

Cristina M Coelho, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal University of Juiz de Fora

Locations

University Hospital of the Federal University of Juiz de Fora

Juiz de Fora, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

13804413.3.1001.5133

Identifier Type: -

Identifier Source: org_study_id