Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009778

Trial Description

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Title

Validity and usability of an activity monitor (A300 Firma Polar) for monitoring physical activity in patients with chronic obstructive pulmonary disease (COPD)

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Two gadgets for measuring the physical activity in patients are compared. It`s the Polar A300 watch (Polar Electro GmbH, Finnland) and the SenseWear bracelet (Bodymedia, Pittsburgh, PA, USA). This is applied in COPD patients in order to display the achievement of daily physical activity by this monitoring.

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Brief Summary in Scientific Language

In the course of this study the comparison of two " Physical Activity Monitor " - devices is intended , namely, the more cost-effective polar A300 clock ( Polar Electro GmbH , Finland ) against the high-priced SenseWear Armband ( Body Media , Pittsburgh , PA , USA ) . It is assumed that using these devices for patients with COPD they can help to achieve the required daily physical activity

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Organizational Data

  •   DRKS00009778
  •   2015/12/18
  •   [---]*
  •   yes
  •   Approved
  •   111/15, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Chronic obstructive pulmonary disease
  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
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Interventions/Observational Groups

  •   Everyone in a group of 10 participants receives the SenseWear bracelet ( Body Media , Pittsburgh , PA , USA ) . Each participant had never experienced an activity tracker and was informed about its handling by a professional. After the participants have worn the bracelet for 3 days , they completed a questionnaire regarding the manageability , usability and acceptability of the bracelet.
    The data that was collected included the number of steps , calories , daily activity time and quality of sleep.
  •   Everyone in a second group of 10 participants receives the Polar A300 watch (Polar Electro GmbH, Finnland). Each participant had never experienced an activity tracker and was informed about its handling by a professional. After the participants have worn the watch for 3 days , they completed a questionnaire regarding the manageability , usability and acceptability of the watch.
    The data that was collected included the number of steps , calories , daily activity time and quality of sleep.
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

comparison of the electronic recordings, calorie consumption, activity time of the SWS (Body Media Inc., US) and the A300 Uhr (Polar, Finnland), measured for 3 days

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Secondary Outcome

16-item-usability questionnaire to evaluate the usability of the items with a 7 - point Likert Scale

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/11/10
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   90   Years
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Additional Inclusion Criteria

COPD I-IV, ability to walk, informed consent

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Exclusion Criteria

deficient mobility/ lack of mobility, lack of informed consent, diseases that restrict physical activity (acute pneumonia, cardiac insufficiency, recent operation,...)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Giessen und Marburg GmbH
    • Mr.  Dr.  Tobias  Böselt 
    • Baldingerstraße
    • 35033  Marburg
    • Germany
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    • St. Remigius Krankenhaus
    • Mr.  Dr.  Marc  Spielmanns 
    • An St. Remigius 26
    • 51379  Leverkusen
    • Germany
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    • Universitätsklinikum Giessen und Marburg GmbH
    • Mr.  Dr.  Tobias  Böselt 
    • Baldingerstraße
    • 35033  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • St. Remigius Krankenhaus
    • Mr.  Dr.  Marc  Spielmanns 
    • An St. Remigius 26
    • 51379  Leverkusen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/10
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.