COPD
Conditions
Keywords
COPD, Physical activity, Endothelial function
Brief summary
Long-term evaluation of a coaching program which helps patients with severe COPD to increase their daily step count, in addition to usual care.
Detailed description
Daily physical activity (PA) is a predictor of survival in the general population and has become a significant outcome measure in patients with COPD. Recent studies have demonstrated an independent association between PA, hospitalizations and mortality. Increased PA has significant benefits for patients with COPD. In most studies PA has only been assessed at one time point. Little is known about longitudinal changes in PA and data on determinants of changes in PA are scant. Moreover, information on best approaches to enhance PA in a population with decreasing PA is missing. To evaluate the long-term effect of a coaching program which is aimed at helping patients with severe COPD (FEV1\<50%) to enhance their level of daily physical activity, in addition to usual care. Furthermore, this study aims to evaluate mechanisms that are responsible for changes of physical activity over time such as sociodemographic factors, lung function, comorbidities, vascular function, exacerbations, and medication.
Interventions
BEHAVIORALIntervention
Patients allocated to the intervention group receive a pedometer. They are encouraged to be more active by using the pedometer to measure the number of steps walked daily. An increase in step count of 15% compared to baseline will be set as the minimal goal for each patient. Monthly telephone calls are indicated to encourage compliance with the protocol and motivate patients to enhance their level of activity. The coached program ends after three months but patients keep their pedometer and are encouraged to sustain an increased level of daily physical activity for additional 9 months (end of study).
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Eligible patients will be randomized 1:1 to one of the two groups: conventional care group or intervention group. No minimization procedures are used.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Age ≥ 40 years * Severe COPD (FEV1\<50%) diagnosed according to GOLD-guidelines (www.goldcopd.org)
Exclusion criteria
* Physical or intellectual impairment precluding informed consent or protocol adherence * Acute or recent (within the last 6 weeks) exacerbation of COPD * Attending a pulmonary rehabilitation program within the last 6 months * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between the changes in number of steps per day (assessed over one week) from baseline to 12 months in the intervention group compared to controls. | 12 months | At visits, the number of steps per day will be assessed by a multisensory band (SenseWear Pro™; Bodymedia Inc., Pittsburgh, PA, USA) which will be worn on the upper left arm for 7 consecutive days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of endothelial function by flow-mediated dilatation | 12 months | Flow-mediated dilatation measurements will be performed by ultrasonography of the brachial artery with a high-frequency (10.0-MHz) ultrasound-scanning probe proximal to the antecubital fossa. Flow mediated dilatation will be assessed by percent of baseline Diameter. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Weight | months | Body weight (Kilogram) |
| Blood pressure | 12 months | Blood pressure (mmHg) is measured in triplicate separated by 1-minute intervals after resting in supine position for 5 minutes in a quiet room with a validated, semi-automated oscillometric device |
| Herat rate | 12 months | Heart rate (bpm) is measured in triplicate separated by 1-minute intervals after resting in supine position for 5 minutes in a quiet room. |
| Blood gas analysis | 12 months | Daytime blood gas analysis will be performed without supplemental oxygen and immediately analysed with a commercially available blood gas analyser (ABL90 Radiometer Copenhagen. Arterial pressure of oxygen (PaO2) and carbon dioxide (PaCO2) will be assessed. Further, oxygen saturation (SaO2) will be determined. |
| Number of COPD exacerbations | 12 months | The number of COPD exacerbations in the previous year and during the study period will be assessed |
| Questionnaire: COPD Assessment Test (CAT) | 12 months | The test is designed to measure the impact of COPD on the patients' life and how this changes over time. The test includes 8 questions each with a scale from 0 to 5. The eight questions not only address respiratory or chest-related symptoms such as cough or sensation of mucus accumulation or chest tightness, but also more general complaints such as disturbances in sleep or decreased energy levels and daily limitations resulting from the disease. The total score will be assessed. |
| Questionnaire: Physical acitivity questionnaire | 12 months | The questionnaire includes items about household activities, sport, and leisure time activities. The time and intensity spent at different physical acitivty levels will be assessed. |
| Questionnaire: Short-Form 36 (SF-36) Questionnaire | 12 months | The SF-36 consists of eight scaled scores that are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The categories are vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health |
| Comorbidities | 12 months | The number and type of medical comorbidities will be assessed by interview. |
| Questionnaire: Hospital Anxiety and Depression Scale (HADS): | 12 months | The questionnaire is especially designed for patients with physical impairment and assesses their symptoms of anxiety and depression. There are 7 items for each domain (anxiety and depression). Agreement on statements is expressed on a scale from 0 to 3 and domain scores are calculated by summing up the scores for the 7 items resulting in scores from 0 (no anxiety/depression) to 21 (depression/anxiety very likely). |
| Height | 12 months | Body height (meter) |
Countries
Switzerland
Outcome results
None listed