Lifestyle Physical Activity for People With COPD

NCT01856231 | Completed

• 1 other identifier: HUM00038130
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Keywords

COPD; Physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in 6 minute walk test

  During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18

• Change in lower extremity function (Short Physical Performance Battery)

  During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18

• Change in dyspnea and fatigue (Pulmonary Functional Status and Dyspnea Questionnaire-Modified)

  During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18

• Change in physical activity measured by CHAMPS questionnaire

  During initial visit (week 1), at 6 or 10 weeks (depending on group placement), and at week 18

Study Arms (1)

8 week group

EXPERIMENTAL

Lifestyle physical activity self-efficacy

Behavioral: Lifestyle physical activity - self-efficacy

Interventions

Lifestyle physical activity - self-efficacy BEHAVIORAL

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.

8 week group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan - School of Nursing

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Janet Larson, PhD

  University of Michigan - School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Lifestyle physical activity self-efficacy

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 17, 2013
• Study Start: August 1, 2011
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

US (1)