Lifestyle Physical Activity for People With COPD

COPD Clinical Trial

Official title:

Lifestyle Physical Activity for People With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856231
• Other study ID #: HUM00038130
• Status: Completed
• Phase: N/A
• First received: May 9, 2013
• Last updated: September 22, 2017
• Start date: August 2011
• Est. completion date: July 1, 2017

Study information

• Verified date: September 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this preliminary study is to examine the effects of a program that includes two-months of structured lab-based training. The proposed study will examine the effects of a lifestyle physical activity intervention designed to increase PA in people with moderate and severe COPD. The intervention includes a combination of (a) structured laboratory-based exercises with a behavioral intervention, (b) structured home-based exercises and (c) lifestyle physical activities performed at home. The subjects will be followed for a total of 18 weeks.

Description:

People with chronic obstructive pulmonary disease (COPD) experience a gradual decline in physical activity (PA). Exercise training in a structured pulmonary rehabilitation program can generate substantial gains in functional capacity, but increases in functional capacity do not necessarily lead to improvements in daily PA. The proposed study will examine the effects of a lifestyle physical activity intervention designed to increase PA in people with moderate and severe COPD. The intervention includes a combination of (a) structured laboratory-based exercises with a self-efficacy enhancing intervention, (b) structured home-based exercises and (c) lifestyle physical activities performed at home. The intervention gradually transitions subjects from the structured laboratory-based exercises that focus on walking and circuit training to fully integrated lifestyle physical activities that integrate structured home-based exercises and lifestyle physical activities into daily life. The purpose of this preliminary study is to examine the effects of a program that includes two-months of structured lab-based training and subjects will be followed for a total of 18 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• 55 years or older

• Moderate to severe COPD (FEV1 < 80% and > 30% predicted; FEV1/FVC <70%) as the primary health problem

• Sedentary (less than 30 minutes of moderate activity 3 days/week)

Exclusion Criteria:

• No acute exacerbations or major illnesses requiring hospitalization in the last 8 weeks.

• No history of other major lung diseases as primary pulmonary problem, history of a recent heart attack or recent onset of chest pains with activity or increasing episodes of chest pain (unstable angina).

• No other health problems or mobility problems that limit physical activity.

• No child bearing potential

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• Lifestyle physical activity - self-efficacy
Subjects will come into an exercise lab 2 days per week and perform 10-20 minutes of walking, 13 strength training exercises, stretching and a behavioral intervention including goal setting, etc.

Locations

Country	Name	City	State
United States	University of Michigan - School of Nursing	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical activity measured by accelerometry	Subjects wear two activity monitors for seven consecutive days (Actipal and Actigraph). The study will compare the subject's activity level at the three time points listed.	During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Secondary	Change in 6 minute walk test	Subjects complete a 6 minute walk test measuring the total distance he/she can walk in 6 minutes at the three time points listed.	During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Secondary	Change in lower extremity function (Short Physical Performance Battery)	Subjects complete a performance test measuring balance, gait speed, and leg strength (using a chair stand test) at the three time points listed.	During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Secondary	Change in dyspnea and fatigue (Pulmonary Functional Status and Dyspnea Questionnaire-Modified)	Subjects complete a questionnaire answering questions about their level of dyspnea in various daily activities at the three time points listed.	During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18
Secondary	Change in physical activity measured by CHAMPS questionnaire	Subjects fill out a questionnaire of their perceived physical activity at the three time points listed.	During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18