Trial document




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  DRKS00016864

Trial Description

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Title

BewARe - Analysis of load requirements

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Trial Acronym

BAB

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URL of the Trial

https://www.beware-projekt.de/

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Brief Summary in Lay Language

The object of the explorative observational study is the acquisition of vital parameters of seniors in rehabilitation heart sports in phase III.

The planned study is part of the BMBF-funded project "BewARe - Sensor-supported movement training for seniors in an intelligent augmented reality system" as part of the BMBF Programme "Interactive systems in virtual and real spaces - Innovative technologies for a healthy life".

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Brief Summary in Scientific Language

- Determination of framework data during cardiac sports by seniors (minimum age 60 years old) with cardiovascular diseases

- Determination of the subjective perception of the adequate stress intensity by the participants and leaders of the cardiac sports group


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Organizational Data

  •   DRKS00016864
  •   2019/04/01
  •   [---]*
  •   yes
  •   Approved
  •   EA/259/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1229-5347 
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Health Condition or Problem studied

  •   I10.9 -  [generalization I10: Essential (primary) hypertension]
  •   I99 -  Other and unspecified disorders of circulatory system
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Interventions/Observational Groups

  •   Before the start of the study, participants will be informed of the objectives and purposes of the observational study by an information event. Participants who have agreed to participate in this study will be checked for inclusion and exclusion criteria. On the test day, participants receive questionnaires with an integrated Borg scale. Validated assessments and objective measurements of vital parameters are carried out. In addition, the training unit is documented by the study personnel.

    With the heart sport group leaders an assessment is carried out by means of a questionnaire with integrated Borg scale to evaluate the load of the participants.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Analysis of the subjective perception of the adequate stress intensity by the participants:

- Questionnaire for the acquisition of framework data such as age, gender, height, weight as well as medical history and the duration of participation in rehabilitation heart sport groups

- Heart rate measurement by means of a Wearable watch, which is worn on the wrist and records the pulse over the entire training period

- Blood pressure measurement using a conventional digital blood pressure monitor

- Questionnaire on self-assessment, which contains standardized assessments such as the Borg scale and scale for recording perceived physical condition (WKV-20)

- Further questions refer to the pulse, the exercises or the evaluation of the heart sport group leader.

- Questionnaire for the stress assessment of the participants, which contains standardized assessments such as the Borg scale filled by the heart sport group leader

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Secondary Outcome

Comparison of subjective perception and objective measurement data of the participants during the rehabilitation heart sport group

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/04/04
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   no maximum age
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Additional Inclusion Criteria

Participant:

- ≥ 60 years
- Participant of phase III cardiac rehabilitation
- Diagnosed cardiovascular disease
- Informed about the study
- signed consent from the participant

Phase III cardiac rehabilitation group Leader:
- currently active as cardiac rehabilitation group leader
- at least 3 years professional experience

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Exclusion Criteria

Participant:

- Participant of Phase I+II cardiac rehabilitation
- resting blood pressure over 200/110 mmHg
- Exclusion of the participant from the training unit by the attending physician of the cardiac sport group
- Presence of legal support

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Addresses

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    • Charité - Universitätsmedizin Berlin - Forschungsgruppe Geriatrie
    • Reinikendorferstraße 61
    • 13347  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin - Forschungsgruppe Geriatrie
    • Ms.  Susan  Vorwerg 
    • Reinikendorferstraße 61
    • 13347  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin - Forschungsgruppe Geriatrie
    • Ms.  Susan  Vorwerg 
    • Reinikendorferstraße 61
    • 13347  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.