Trial document




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  DRKS00018805

Trial Description

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Title

Validation of activity trackers in older women with an increased cardiac risk or a diagnosed heart disease

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Trial Acronym

VIVA KAREN60+

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URL of the Trial

http://www.hs-gesundheit.de/karen60+

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Brief Summary in Lay Language

The study aims to determine how precise various activity trackers (ActiGraph wGT3X, Actiheart 4, commercial pedometers) are able to the register physical activity and estimate physical activity energy expenditure in comparison to the indirect calorimetry as the golden standard in women over 60 years with increased cardiac risk or diagnosed heart disease in a stable condition.
Activity trackers are devices detecting physical activity by acceleration or steps. The gold standard, the indirect calorimetry is measuring the respiratory gases.

The registration of physical activity, defined as every movement made by the skeletal muscles increasing the energy expenditure and the resting potential, becomes more and more important for physiotherapists (Müller, Winter & Rosenbaum, 2010; Thiel, Vogt & Banzer, 2012). It may be used for the identification of behavioral patterns and its determinants for personal advice, individual training load, support and mediation of self-efficacy in cardiac prevention, therapy and rehabilitation (Bjarnason-Wehrens et al., 2009).

In general, accelerometers seem to be the right instruments to measure physical activity in older and chronically ill adults (Strath, Pfeiffer, & Whitt-Glover, 2012; Taraldsen, Chastin, Riphagen, Vereijken, & Helbostad, 2012) and patients (Broderick, Ryan, O'Donnell, & Hussey, 2014; Strath et al., 2013). However, most of the scientific systems detecting physical activity are developed and validated in young male adults and are not validated in older women with increased cardiac risk or diagnosed cardiac diseases. It is unclear if the raw data processing (e.g. cut-off values and regression equations) is also applicable in older women, whose motor function may be different (Matthews, Hagstromer, Pober, & Bowles, 2012).

Devices with an intelligent calculation of combined assessments seem to be a promising approach in comparison to simply accelerometry. These devices also include data such as location (GPS) or heart rate to provide a more accurate profile (Brage, Brage, Franks, Ekelund, & Wareham, 2005). Until now neither these combined devices, nor simple and cost-effective tracking systems (e.g. Pedometers) are validated for medical, therapeutic or scientific use in older women with an increased cardiac risk or a diagnosed heart disease in a stable condition.
The results of this validation study should help therapists, clients, researches and health insurances to find the appropriate and valid device to detect physical activity in the target group.

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Brief Summary in Scientific Language

Validation of activity trackers against indirect calorimetry for the registration of physical activity and the prediction of physical activity energy expenditure in women over 60 years with increased cardiac risk or diagnosed heart disease in a stable condition.

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Organizational Data

  •   DRKS00018805
  •   2019/11/14
  •   [---]*
  •   yes
  •   Approved
  •   2019-06, Ethikkommission des Deutschen Verbandes für Physiotherapie an der Physio-Akademie
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Secondary IDs

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

  •   I10-I15 -  Hypertensive diseases
  •   I20-I25 -  Ischaemic heart diseases
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Interventions/Observational Groups

  •   This study aims to determine which activity tracker (ActiGraph wGT3X, Actiheart 4, and two commercially available pedometer) shows the best validity in accurately measuring physical activity and recording physical activity energy expedniture (PAEE) versus the gold standard of indirect calorimetry in women over 60 with cardiac risk or clinically stable heart disease.

    For this purpose, physical activity and PAEE are measured using an activity protocol with simulated activities of daily living and a ergometertest on the bicycle ergometer using the above-mentioned measuring instruments.
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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

Difference in physical activity energy expenditure (PAEE) as estimated by activity trackers (ActiGraph wGT3X, Actiheart 4, commercial pedometers) versus PAEE measured by indirect calorimetry.
Criterion validity

One-time Registration of physical activity or physical activity related energy expenditure with an activity protocol (consisting of simulated activites of daily living and cycle ergometertest):
• Indirect calorimetry: VO2 and VCO2 data collection breath-by-breath (Cortex Metalyzer System) and heartrate (Polar) step load test protocol on a bicycle ergometer (25W/2min, Start at 25W)
End point: subjective maximal load
If maximum load is not possible because of medical or professional societies’ advice: end point is BORG 15
• ActiGraph (ActiGraph LLC, Fort Walton Beach, FL, USA)
• ActiHeart (CamNtech, Cambridge, GB)
• Two commercial standard measurement instruments (Pedometers, one smartphone based) e.g. Walking Style IV Step Counter (Omron Healthcare UK LTD, Milton Keynes, UK) and UPmove (Jawbone, San Francisco, CA, USA)

Additional questionnaires:
• Screening questionnaire (based on Physical Activity Readiness Questionnaire (PAR-Q) and sports-medical examination questionnaire „Erhebungsbogen sportärztliche Vorsorgeuntersuchung/Anamnese “)
• Global Physical Activity Questionnaire (GPAQ)
• 36-Item Short Form Health Survey (SF-36)
• Physical activity-related health competence (“Bewegungsbezogene Gesundheitskompetenz”)

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/11/11
  •   45
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

- women over 60 years
- diagnosed with a cardiac disease or with an increased cardiac risk >1 for 10 years of cardiovascular mortality with risk assessment (SCORE) in accordance to the European Society of Cardiology
- able to perform physical activities safely
- in case of an increased cardiac risk: medical permission to perform a graded exercise test while reaching BORG 15
- sufficient knowledge of written and spoken German language

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Exclusion Criteria

- instable cardiovascular disease, without medical permission for physical activity or medical release for load test
- missing medical preliminary investigation in the event of unclear health status or existing indications for relative contraindications
- serious illness (tumors, fractures, acute infections, central neurological disorders, cognitive impairments) where in this specific situation physical activity is contraindicated or participation is unsafe
- severe physical immobility or limitation of mobility where support for climbing stairs, as well as for standing up or sitting down (stair, stationary bicycle ergometer) is needed
- severe neurodermitis or other severe skin diseases
- serious acute infections
- impairment of wound healing or severe sensibility disturbances of the legs (diabetic foot) caused by diabetes mellitus type II and without medical permission for physical activity or load test
- other contraindications for physical activity according to recommendations from professional societies

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Hochschule für Gesundheit
    • Mr.  Prof. Dr. phil. habil.  Christian  Thiel 
    • Gesundheitscampus 6-8
    • 44801  Bochum
    • Germany
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    • Hochschule für Gesundheit
    • Mr.  Prof. Dr. phil. habil.  Christian  Thiel 
    • Gesundheitscampus 6-8
    • 44801  Bochum
    • Germany
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    • Hochschule für Gesundheit
    • Ms.  Alina  Rieckmann 
    • Gesundheitscampus 6-8
    • 44801  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Hochschule für Gesundheit
    • Mr.  Prof. Dr. phil. habil.  Christian  Thiel 
    • Gesundheitscampus 6-8
    • 44801  Bochum
    • 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.