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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984281
• Other study ID #: 13804413.3.1001.5133
• Status: Completed
• Phase: N/A
• First received: November 8, 2013
• Last updated: February 13, 2017
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2017
• Source: Federal University of Juiz de Fora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Brazil	University Hospital of the Federal University of Juiz de Fora	Juiz de Fora	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Juiz de Fora

Country where clinical trial is conducted

Brazil, 

Outcome

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