Chronic Obstructive Pulmonary Disease
Conditions
Keywords
physical activity, Chronic Obstructive Pulmonary Disease
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.
Interventions
BEHAVIORALActive Life
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.
BEHAVIORALChair exercises
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.
Sponsors
National Institute of Nursing Research (NINR)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor | 7 days of continuous activity monitoring w as monitored on each participants at each of five test periods (T1-T5) | The primary dependent variables are the time spent in physical activity (PA) as measured by Upright time monitored in each of the five intervals of the study over a 15-month period. PA will be measured for 7 consecutive days at each measurement using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5) |
| Time Spent in Sedentary Behavior | 7 days of continuous activity monitoring at each interval | The primary dependent variable are the time spent in sedentary activity as measured as Sedentary Activity (SA) time monitored in each of the five intervals of the study over a 15-month period. SA will be measured for 7 consecutive days at each interval using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute Walk Test | Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention | This is the maximal distance a subject can walk during six minutes. |
Countries
United States
Participant flow
Recruitment details
All subjects recruited had a diagnosis of COPD, were between the ages of 60-85 years, and had an FEV1%predicted less than 80%. Subjects recruited were stratified by gender and FEV1%predicted severity as part of the randomization process.
Pre-assignment details
A total of 182 subjects were enrolled and randomized across both groups. Five subjects were not able to complete baseline assessment leaving 177 randomized subjects who completed baseline assessment.
Participants by arm
| Arm | Count |
|---|---|
| Active Life The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Active Life: 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. | 92 |
| Chair Exercises The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.
Chair exercises: 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. | 90 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete f reasons; lost to follow-up, subject withdrew, family illnesses, moving, etc. | 35 | 37 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Active Life | Chair Exercises | Total |
|---|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 7.8 | 70.3 years STANDARD_DEVIATION 8.5 | 69.4 years STANDARD_DEVIATION 8.1 |
| FEV1%Predicted | 53.77 Percent of actual to predicted STANDARD_DEVIATION 15.6 | 56.99 Percent of actual to predicted STANDARD_DEVIATION 13.5 | 55.4 Percent of actual to predicted STANDARD_DEVIATION 14.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 13 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 7 Participants | 17 Participants |
| Race (NIH/OMB) White | 70 Participants | 68 Participants | 138 Participants |
| Sex: Female, Male Female | 37 Participants | 38 Participants | 75 Participants |
| Sex: Female, Male Male | 45 Participants | 46 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 82 | 1 / 84 |
| other Total, other adverse events | 17 / 82 | 12 / 84 |
| serious Total, serious adverse events | 7 / 82 | 5 / 84 |
Outcome results
Primary
Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor
The primary dependent variables are the time spent in physical activity (PA) as measured by Upright time monitored in each of the five intervals of the study over a 15-month period. PA will be measured for 7 consecutive days at each measurement using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)
Time frame: 7 days of continuous activity monitoring w as monitored on each participants at each of five test periods (T1-T5)
Population: Number of participants who were analyzed at each time period (T1-T5) varied due to participants withdrawing, not being available to keep their test appointments, illness, etc. T1=baseline, T2=testing at completion of intervention, T3= 3 months following intervention, T4=6 months following intervention, T5=12 months following intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Life | Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor | T2 | 293 minutes per day | Standard Deviation 138 |
| Active Life | Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor | T4 | 282 minutes per day | Standard Deviation 154 |
| Active Life | Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor | T3 | 293 minutes per day | Standard Deviation 156 |
| Active Life | Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor | T5 | 277 minutes per day | Standard Deviation 145 |
| Active Life | Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor | Baseline-T1 | 278 minutes per day | Standard Deviation 144 |
| Chair Exercises | Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor | T5 | 299 minutes per day | Standard Deviation 146 |
| Chair Exercises | Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor | Baseline-T1 | 269 minutes per day | Standard Deviation 138 |
| Chair Exercises | Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor | T2 | 285 minutes per day | Standard Deviation 130 |
| Chair Exercises | Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor | T3 | 279 minutes per day | Standard Deviation 138 |
| Chair Exercises | Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor | T4 | 257 minutes per day | Standard Deviation 99 |
Primary
Time Spent in Sedentary Behavior
The primary dependent variable are the time spent in sedentary activity as measured as Sedentary Activity (SA) time monitored in each of the five intervals of the study over a 15-month period. SA will be measured for 7 consecutive days at each interval using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)
Time frame: 7 days of continuous activity monitoring at each interval
Population: Participant/unit totals differ from overall number analyzed due to invalid or incomplete monitoring of subjects or subjects withdrawals between intervals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Life | Time Spent in Sedentary Behavior | T2 | 661 average minutes per day | Standard Deviation 173 |
| Active Life | Time Spent in Sedentary Behavior | T4 | 683 average minutes per day | Standard Deviation 182 |
| Active Life | Time Spent in Sedentary Behavior | T3 | 661 average minutes per day | Standard Deviation 180 |
| Active Life | Time Spent in Sedentary Behavior | T5 | 671 average minutes per day | Standard Deviation 174 |
| Active Life | Time Spent in Sedentary Behavior | Baseline (T1) | 683 average minutes per day | Standard Deviation 180 |
| Chair Exercises | Time Spent in Sedentary Behavior | T5 | 639 average minutes per day | Standard Deviation 169 |
| Chair Exercises | Time Spent in Sedentary Behavior | Baseline (T1) | 698 average minutes per day | Standard Deviation 187 |
| Chair Exercises | Time Spent in Sedentary Behavior | T2 | 658 average minutes per day | Standard Deviation 177 |
| Chair Exercises | Time Spent in Sedentary Behavior | T3 | 672 average minutes per day | Standard Deviation 180 |
| Chair Exercises | Time Spent in Sedentary Behavior | T4 | 681 average minutes per day | Standard Deviation 160 |
Secondary
Six-minute Walk Test
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
Population: Participant/unit totals differ from overall number analyzed due to invalid or incomplete testing of subjects or subjects withdrawals between intervals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Life | Six-minute Walk Test | T3 | 1320 Feet | Standard Deviation 343 |
| Active Life | Six-minute Walk Test | T4 | 1339 Feet | Standard Deviation 280 |
| Active Life | Six-minute Walk Test | T2 | 1368 Feet | Standard Deviation 254 |
| Active Life | Six-minute Walk Test | T5 | 1311 Feet | Standard Deviation 267 |
| Active Life | Six-minute Walk Test | Baseline (T1) | 1241 Feet | Standard Deviation 306 |
| Chair Exercises | Six-minute Walk Test | T5 | 1264 Feet | Standard Deviation 307 |
| Chair Exercises | Six-minute Walk Test | T3 | 1281 Feet | Standard Deviation 295 |
| Chair Exercises | Six-minute Walk Test | T2 | 1234 Feet | Standard Deviation 339 |
| Chair Exercises | Six-minute Walk Test | T4 | 1272 Feet | Standard Deviation 294 |
| Chair Exercises | Six-minute Walk Test | Baseline (T1) | 1202 Feet | Standard Deviation 324 |