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Individualized exercise promotion program for people with multiple manifested risk factors to increase physical exercise in the long term (MultiPill-Exercise)

Individualized exercise promotion program for people with multiple manifested risk factors to increase physical exercise in the long term (MultiPill-Exercise) - MultiPill-Exercise

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025033
Enrollment
320
Registered
2021-09-30
Start date
2022-04-19
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Diabetes mellitus type 2, cardio-vascular diseases, knee and/or hip osteoarthritis, overweight/obesity Depression, osteoporosis, chronic low back pain

Interventions

Group 1: Intervention MultiPill-Exercise: Participants receive an intervention over 24 weeks. The intervention is based on the International Classification of Functioning, Disability and Health (ICF).

Sponsors

AOK Baden-Württemberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: AOK insured (at least 2 years in advance), constant medication for at least 3 months, at least 2 of 4 risk factors or manifested diseases: Diabetes mellitus type 2 (diabetes risk test > 57 points), cardiovascular disease (PROCAM > 10-year risk of heart attack 10%, hip and/or knee osteoarthritis (diagnosed by a physician in advance), overweight/obesity (BMI > 27 kg/m²).

Exclusion criteria

Exclusion criteria: End-organ damage, appointment for selective joint replacement, exercise activity before start of intervention > 75 % of the nationale physical activity recommendations, personal possible exercise time < 20 minutes at a time.

Design outcomes

Primary

MeasureTime frame
Physical Activity Status, evaluated with the self-reported EHIS-PAQ (HEPA-Index) 6, hierarchichal after 18 months after baseline.

Secondary

MeasureTime frame
Activity Status (EHIS-PAQ: Muscle Strength, Accelerometry), General Health-Related Quality of Life (Veterans Rand-12), Disease-Specific Measures (HOOS, KOOS, Diabetes Risk Test, PROCAM score, VAS), Performance Measures (Spiroergometry, Resting and Exercise ECG, 30-Second Sit-Stand Test, BIA, Fasting Blood Collection and Capillary Blood Collection on Guthrie Cards), Sport and Health Psychology Measures (Self-Efficacy Expectancy, Self-Concordance, exercise-related health competence, exercise-related motivational competence, ability to plan and act, affective attitude toward exercise, motives and goals of exercise, exercise anxiety), economic data (nonspecific and specific illness-related costs and days of illness, intervention costs), process evaluation (satisfaction with the intervention and trainers, feasibility), attendance and safety (training diaries and attendance lists). Questionnaires will be conducted at baseline and after 3, 6, 12, 18 months. Physical performance measures will be hold at baseline and after 6 and 18 months.

Countries

Germany

Contacts

Public ContactSimone Schweda

Universitätsklinikum Tübingen, Medizinische Klinik, Abteilung Sportmedizin

simone.schweda@med.uni-tuebingen.de07071 2986477

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026