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

Validation of activity trackers in older women with an increased cardiac risk or a diagnosed heart disease - VIVA KAREN60+

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00018805
Enrollment
45
Registered
2019-11-14
Start date
2019-11-11
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I10-I15 I20-I25

Interventions

Group 1: 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

Sponsors

Hochschule für Gesundheit
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
65 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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”)

Countries

Germany

Contacts

Public ContactAlina Rieckmann

Hochschule für Gesundheit

alina.rieckmann@hs-gesundheit.de+49 234 77727-691

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026