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

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ClinicalTrials.gov Identifier: NCT03114241
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
COPD Behavioral: Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Long-term Effects of a 3-month Pedometer-based Program to Enhance Physical Activity in Patients With Severe COPD
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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).

No Intervention: Control
Usual care.



Primary Outcome Measures :
  1. 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. [ Time Frame: 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 Outcome Measures :
  1. Assessment of endothelial function by flow-mediated dilatation [ Time Frame: 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 Outcome Measures:
  1. Number of COPD exacerbations [ Time Frame: 12 months ]
    The number of COPD exacerbations in the previous year and during the study period will be assessed

  2. Height [ Time Frame: 12 months ]
    Body height (meter)

  3. Weight [ Time Frame: months ]
    Body weight (Kilogram)

  4. Blood pressure [ Time Frame: 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

  5. Herat rate [ Time Frame: 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.

  6. Blood gas analysis [ Time Frame: 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.

  7. Questionnaire: Hospital Anxiety and Depression Scale (HADS): [ Time Frame: 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).

  8. Questionnaire: COPD Assessment Test (CAT) [ Time Frame: 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.

  9. Questionnaire: Physical acitivity questionnaire [ Time Frame: 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.

  10. Questionnaire: Short-Form 36 (SF-36) Questionnaire [ Time Frame: 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

  11. Comorbidities [ Time Frame: 12 months ]
    The number and type of medical comorbidities will be assessed by interview.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114241


Contacts
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Contact: Christian F Clarenbach, MD +41442551712 christian.clarenbach@usz.ch
Contact: Noriane Sievi, MSc +41442559815 noriane.sievi@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zürich, Zurich, Switzerland, 8091
Contact: Christian F Clarenbach, MD    +41 44 255 17 12    christian.clarenbach@usz.ch   
Contact: Noriane A Sievi, MSc    +41 44 255 98 15    noriane.sievi@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Christian F Clarenbach, MD University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03114241     History of Changes
Other Study ID Numbers: Basec-Nr. 2016-00151
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
COPD
Physical activity
Endothelial function