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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pedometer-based physical activity prescription
Sponsored by
Federal University of Juiz de Fora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Physical Activity, Pedometers, Quality of Life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of the Federal University of Juiz de Fora

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pedometer-based prescription

Control

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
November 8, 2013
Last Updated
February 13, 2017
Sponsor
Federal University of Juiz de Fora
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1. Study Identification

Unique Protocol Identification Number
NCT01984281
Brief Title
Effects of a Pedometer-based Unsupervised Exercise Program Upon Lifestyle Physical Activity of Asthmatic Adults
Official Title
Effects of a Pedometer-based Unsupervised Exercise Program Upon Lifestyle Physical Activity of Asthmatic Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Juiz de Fora

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Physical Activity, Pedometers, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pedometer-based prescription
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Pedometer-based physical activity prescription
Intervention Description
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 Outcome Measure Information:
Title
Lifestyle physical activity
Description
The lifestyle physical activity will be estimated as the mean number of steps taken in six days using a pedometer (SW200, YAMAX,Tokyo, Japan)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Exercise capacity
Description
Exercise capacity will be assessed through the six-minute walking teste.
Time Frame
12 weeks
Title
Asthma Health related quality of life
Description
Asthma Health related quality of life will be assessed through the Asthma Quality of Life Questionnaire.
Time Frame
12 weeks
Title
Asthma Control
Description
Asthma Control will be assessed through the Asthma Control Questionnaire
Time Frame
12 weeks
Title
Depression and anxiety
Description
Depression and anxiety will be assessed through the Hospital Anxiety and Depression Scale
Time Frame
12 weeks
Title
Asthma exacerbations
Description
Asthma exacerbations will be assessed through exacerbation diaries.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno V Pinheiro, DSc
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cristina M Coelho, MSc
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of the Federal University of Juiz de Fora
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36036-110
Country
Brazil

12. IPD Sharing Statement

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

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