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StepUp GP – A Multimodal Intervention to Promote Physical Activity Among Patients in Geriatric Psychiatry Day Clinics: A Randomized Controlled Pilot Study

StepUp GP – A Multimodal Intervention to Promote Physical Activity Among Patients in Geriatric Psychiatry Day Clinics: A Randomized Controlled Pilot Study - StepUp GP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038022
Enrollment
32
Registered
2025-09-29
Start date
2026-03-03
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Older semi-inpatient patients in geriatric psychiatric care, without cognitive impairment, with diagnoses such as F30–F39 – Affective disorders, schizophrenia/psychotic disorders F20 – Schizophrenia F23 – Acute transient psychotic disorders F25 – Schizoaffective disorders

Interventions

Group 1: Upon admission to the geriatric psychiatric day clinic, patients who are undergoing treatment for a mental illness and who may meet the inclusion criteria are informed about the study verball

Sponsors

LVR Klinik Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients at geriatric psychiatric day clinics with a psychiatric diagnosis, ability to provide a signed consent form, mild cognitive impairment (Mini Mental Status Test = 20), ability to stand for at least 3 minutes without assistance (self-assessment)

Exclusion criteria

Exclusion criteria: F22.0 Isolated delusional disorders, mobility, cognitive, sensory, and/or psychiatric impairments or comorbidities that affect the ability to participate and/or perform pre- and post-examinations, insufficient knowledge of the German language to participate in the health lecture and/or record activities, immobility, wheelchair dependency

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is the feasibility of a pedometer intervention in older dayclinic patients. Feasibility is an umbrella term that encompasses various measures of acceptance and safety. - Recruitment rate (% of willingness to participate relative to patients to be included) - Adherence (% of training sessions attended relative to planned training sessions) - Dropout rate - Safety (reporting of side effects, adverse outcomes) - Applicability (System Usability Scale (Brooke, 1995)) - Perceived effects, perceived safety, intention to recommend (customized questionnaire with multiple-choice and open-ended questions) Sequence of measurement points (T1-T4): T0 – Initial measurement: immediately after your admission to the day clinic. T1 – Interim measurement (after 4 weeks of treatment): for all participants. T2 – Additional interim measurement (if necessary): only if your treatment lasts longer than 6 weeks; at the earliest 2 weeks after T1. T3 – Final measurement (4 weeks after discharge): completion of the intervention. T4 – Follow-up interview (8 weeks after discharge): one-time telephone appointment. Time required: approx. 45 minutes per measurement point. Total duration of the study: 8–12 weeks (depending on the duration of treatment).

Secondary

MeasureTime frame
The secondary outcomes of the pilot study are surveys on neuropsychiatric symptoms, the general severity and changes in symptoms of mental disorders, changes in depressive symptoms in patients with depression, physical activity, and sedentary behavior. - General severity and change in symptoms of mental disorders (Clinical Global Impression of Change (CGI) Clinical Global Impression [CGI-S (Impression Severity of Illness) and CGI-I (Impression of Improvement)] (Busner & Targum, 2007)) - Neuropsychiatric symptoms (Clinical scale for assessing Neuropsychiatric Inventory (NPI) (Cummings, 2020)) - Depression (Beck Depression Inventory (BDI-II) (Beck et al., 1961), Hamilton Depression Rating Scale (HAM-D) (Hamilton, 1960)) - Sleep quality (Pittsburgh Sleep Quality Index (PSQI) (Buysse et al., 1989)) - Subjective perception of health status (Auditory Analog Scale for Subjective Perception of Health Status) - Functional mobility (Timed Up and Go Test (TUG) (Podsiadlo & Richardson, 1991) - Gait (10-meter walk test (van Hedel et al., 2005)) - Physical activity (Accelerometer Axivity AX6 (Hedayatrad et al., 2021)) - Sleep behavior (Actigraph MotionWatch 8 (Landry et al., 2015))

Countries

Germany

Contacts

Public ContactLaura Elani Schulte

LVR Klinik Köln

laura.schulte@lvr.de+492218993273

Outcome results

None listed

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