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Active for Life: Chronic Obstructive Pulmonary Disease (ActiveCOPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Life
Chair exercises
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring physical activity, Chronic Obstructive Pulmonary Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  • Acute exacerbations or major illnesses requiring hospitalization in the last 8 weeks.
  • 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).
  • Other health problems or mobility problems that limit physical activity.
  • Participated in a structured exercise program or pulmonary rehabilitation within the last year.

Sites / Locations

  • University of Michigan School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Life

Chair exercises

Arm Description

The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.

The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.

Outcomes

Primary Outcome Measures

Time spent in Physical Activity and sedentary behavior (baseline)
The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.
Time spent in Physical Activity and sedentary behavior (end of intervention)
The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.
Time spent in Physical Activity and sedentary behavior (3 month follow-up)
The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.
Time spent in Physical Activity and sedentary behavior (6 month follow-up)
The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.
Time spent in Physical Activity and sedentary behavior (12 month follow-up)
The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.

Secondary Outcome Measures

Six-minute walk test
This is the maximal distance a subject can walk during six minutes.
Isometric strength (knee flexors and extensors)
This is measured in the seated position with a dynamometer.
PROMIS Physical Function
PROMIS physical function scale - measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low physical function and high scores indicate higher physical function.
Short Physical Performance Battery
Short physical Performance Battery - includes a balance test, gait speed and chair stand

Full Information

First Posted
January 4, 2017
Last Updated
May 18, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03201198
Brief Title
Active for Life: Chronic Obstructive Pulmonary Disease
Acronym
ActiveCOPD
Official Title
Active for Life: Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 27, 2017 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study examines the effects of an exercise and behavioral program, called Active-Life, to promote physical activity in people with chronic obstructive pulmonary disease. A sedentary lifestyle is very common in older people with chronic disease and if this program is successful it will be used to promote physical activity and improve the health of people with chronic obstructive pulmonary disease.
Detailed Description
Physical inactivity is a growing health problem in the United States, especially for older people with chronic diseases such as COPD; in fact people with COPD are among the least active. Low levels of physical activity (PA) are associated with negative health outcomes including an increase in mortality and COPD exacerbations. Current PA guidelines focus on moderate-to-vigorous physical activities (MVPAs) that are too strenuous and not feasible for long term maintenance in many people with COPD. The investigators propose a new paradigm for promoting PA in this population; focus on increasing time spent in light physical activity (LPA) and decreasing time spent in sedentary behavior. Growing evidence suggests that substantial health benefits are associated with increases in the volume of LPA. The investigators are testing the efficacy of the Active-for-Life (Active-Life) intervention. The central hypothesis is that Active-Life will have positive effects on objectively measured PA. Active-Life is a 10 week intervention designed to increase total PA with an emphasis on increasing the time spent in LPA and decreasing sedentary time. Active-Life establishes a goal for subjects, to increase total PA, combined LPA and MVPA, at least 60 minutes a day. This far exceeds the effects of other published PA interventions for people with COPD and if successful will advance PA science in clinically important ways. The Active-Life program was developed by Dr. Larson and through a series of preliminary studies; its feasibility is well established and preliminary data are promising. The investigators are conducting a randomized controlled trial comparing Active-Life against an active control. They will enroll 183 people with moderate to very severe COPD. Outcomes will be measured at baseline, end of the 10 week intervention and at 3, 6 and 12 months after the end of the intervention. The primary dependent variables are objectively measured PA and sedentary behavior, measured with ActivPAL and Actigraph accelerometers simultaneously. Secondary outcome measures are indicators of frailty: 6-minute distance walk, isometric strength of knee flexors and extensors, Short Physical Performance Battery and self-reported physical function. Potential mediators include barriers-efficacy for PA and outcome expectations for PA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
physical activity, Chronic Obstructive Pulmonary Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Active Life
Arm Type
Experimental
Arm Description
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Arm Title
Chair exercises
Arm Type
Sham Comparator
Arm Description
The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Intervention Type
Behavioral
Intervention Name(s)
Active Life
Intervention Description
The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Chair exercises
Intervention Description
Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
Primary Outcome Measure Information:
Title
Time spent in Physical Activity and sedentary behavior (baseline)
Description
The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.
Time Frame
7 days of data are gathered immediately before the beginning of the 10 week intervention
Title
Time spent in Physical Activity and sedentary behavior (end of intervention)
Description
The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.
Time Frame
7 days of data are gathered following completion of the 10 week intervention
Title
Time spent in Physical Activity and sedentary behavior (3 month follow-up)
Description
The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.
Time Frame
7 days of data are gathered 3 months after the completion of the 10 week intervention
Title
Time spent in Physical Activity and sedentary behavior (6 month follow-up)
Description
The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.
Time Frame
7 days of data are gathered 6 months after the completion of the 10 week intervention
Title
Time spent in Physical Activity and sedentary behavior (12 month follow-up)
Description
The primary dependent variables are the time spent in physical activity (PA) and sedentary from ActivPal data. Physical activity will be further described using Actigraph data, It will be described as the time spent in light physical activity and moderate-to-vigorous physical activity. PA will be measured for 7 consecutive days at each measurement.
Time Frame
7 days of data are gathered 12 months after the completion of the 10 week intervention
Secondary Outcome Measure Information:
Title
Six-minute walk test
Description
This is the maximal distance a subject can walk during six minutes.
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Title
Isometric strength (knee flexors and extensors)
Description
This is measured in the seated position with a dynamometer.
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Title
PROMIS Physical Function
Description
PROMIS physical function scale - measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low physical function and high scores indicate higher physical function.
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Title
Short Physical Performance Battery
Description
Short physical Performance Battery - includes a balance test, gait speed and chair stand
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Other Pre-specified Outcome Measures:
Title
Chronic Respiratory Questionnaire Dyspnea Scale
Description
Shortness of breath during physical activities. This is a 5-item scale and potential scores range from 5 - 35. Low scores reflect high levels of dyspnea and higher scores reflect lower levels of dyspnea.
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Title
PROMIS Fatigue
Description
General experience of fatigue - measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low fatigue and high scores indicate higher fatigue.
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Title
PROMIS Anxiety
Description
General experience of anxious moods - measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low anxiety and high scores indicate higher anxiety.
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Title
PROMIS Depression
Description
General experience of depressed moods - measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low depression and high scores indicate higher depression.
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Title
Positive and Negative Social Influences on Physical Activity in Older Adults
Description
Support from family and friends for being physically active. This questionnaire has a total of 27 items, 15 items describing positive social influence and 12 items describing negative social influence. The potential range of scores for positive social influence is 0 to 180 and the potential range of scores for negative social influence is 0 - 144.
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Title
Self-Regulation for Physical Activity Scale
Description
Measures goal setting, self-monitoring and other strategies for being physically active. This is a 12-item questionnaire and the potential range of scores is from 12 to 70. Higher scores indicate higher self-regulation.
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Title
Barriers Efficacy for Physical Activity Scale: Chronic Obstructive Pulmonary Disease
Description
This questionnaire has two scales, one that measures barriers efficacy for light physical activity (14 items) and one that measures barriers efficacy for moderate physical activity (14 items). The potential range of scores for each of the scales is 0% efficacy to 100% efficacy. Higher scores indicate a higher self-efficacy for overcoming barriers to physical activity.
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention
Title
Multidimensional Outcomes Expectations Scale
Description
This questionnaire measures peoples' beliefs or expectations about the benefits of regular exercise or light physical activity. It is a 15 item questionnaire and scores can range from 15-75. Higher scores indicate higher outcomes expectations for exercise
Time Frame
Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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. Sedentary (less than 30 minutes of moderate activity 3 days/week) Exclusion Criteria: Acute exacerbations or major illnesses requiring hospitalization in the last 8 weeks. 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). Other health problems or mobility problems that limit physical activity. Participated in a structured exercise program or pulmonary rehabilitation within the last year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet L Larson, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Nursing
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At this point the investigators have no plans to share IPD, but would consider a request to share deidentified data if it had the potential to advance science in the promotion of physical activity for older adults

Learn more about this trial

Active for Life: Chronic Obstructive Pulmonary Disease

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