Long-term Effects of a 3-month Pedometer-based Program to Enhance Physical Activity in Patients With Severe COPD

COPD Clinical Trial

Official title:

Long-term Effects of a 3-month Pedometer-based Program to Enhance Physical Activity in Patients With Severe COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114241
• Other study ID #: Basec-Nr. 2016-00151
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: May 20, 2020

Study information

• Verified date: June 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 20, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• Intervention
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).

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of COPD exacerbations	The number of COPD exacerbations in the previous year and during the study period will be assessed	12 months
Other	Height	Body height (meter)	12 months
Other	Weight	Body weight (Kilogram)	months
Other	Blood pressure	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	12 months
Other	Herat rate	Heart rate (bpm) is measured in triplicate separated by 1-minute intervals after resting in supine position for 5 minutes in a quiet room.	12 months
Other	Blood gas analysis	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.	12 months
Other	Questionnaire: Hospital Anxiety and Depression Scale (HADS):	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).	12 months
Other	Questionnaire: COPD Assessment Test (CAT)	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.	12 months
Other	Questionnaire: Physical acitivity questionnaire	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.	12 months
Other	Questionnaire: Short-Form 36 (SF-36) Questionnaire	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	12 months
Other	Comorbidities	The number and type of medical comorbidities will be assessed by interview.	12 months
Primary	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.	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.	12 months
Secondary	Assessment of endothelial function by flow-mediated dilatation	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.	12 months