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

Long-term evaluation of a coaching program which helps patients with severe COPD to increase their daily step count, in addition to usual care.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Behavioral: Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8091
      • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care.
Active Comparator: Intervention; An increase in step count of 15% compared to baseline will be set as the minimal goal for each patient during 3 months.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of COPD exacerbations	The number of COPD exacerbations in the previous year and during the study period will be assessed	12 months
Height	Body height (meter)	12 months
Weight	Body weight (Kilogram)	months
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
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
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
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
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
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
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
Comorbidities	The number and type of medical comorbidities will be assessed by interview.	12 months

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Christian F Clarenbach, MD, University of Zurich

Publications and helpful links

General Publications

• Kohlbrenner D, Sievi NA, Senn O, Kohler M, Clarenbach CF. Long-Term Effects of Pedometer-Based Physical Activity Coaching in Severe COPD: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Nov 6;15:2837-2846. doi: 10.2147/COPD.S279293. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: COPD; Physical activity; Endothelial function
• Other Study ID Numbers: Basec-Nr. 2016-00151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No