Prevention of Lifestyle-related Ill-health With Early Functional Examinations and Individualized Risk Profiles
NCT ID: NCT05535296
Last Updated: 2023-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2022-08-15
2023-04-18
Brief Summary
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Aim: To investigate the feasibility of a protocol for a randomized controlled trial (RCT) which will examine the preventive effects of musculoskeletal function examinations and person-centered advice on inactive middle-aged people.
Methods: Physically inactive middle-aged people will be invited to participate in a two-part health examination with follow-up after three months in a pilot study. Part 1 is a standard health examination including blood tests and Part 2 is a functional examination of fitness, strength, mobility, balance and posture according to our protocol based on validated tests. The intervention group receives feedback based on both parts of the examination while the control group receives feedback only from Part 1. Physical activity level will be measured objectively with accelerometers at inclusion and follow-up.
Expected results: The pilot study is expected to show whether the planned RCT is practically feasible and to give relevant support for the power analysis for a later full-scale RCT. Better understanding of personal physical function and risk factors can facilitate lifestyle decisions on the individual level which can reduce the risk for later ill-health and need of health-care. Preventive interventions may contribute to reduce the ever-increasing level of lifestyle-related ill-health.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention group
Standard health examination and related feedback. Functional examination. Risk profile and related advice.
Risk profile
Compiliation of risk profile based on fitness, strength, mobility, balance, posture, physical activity level, weight and pain. Advice based on the above and support in goal-setting.
Control group
Standard health examination and related feedback. Functional examination.
No interventions assigned to this group
Interventions
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Risk profile
Compiliation of risk profile based on fitness, strength, mobility, balance, posture, physical activity level, weight and pain. Advice based on the above and support in goal-setting.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
39 Years
40 Years
ALL
Yes
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Region Värmland, Sweden
UNKNOWN
Lena Bornhoft
OTHER
Responsible Party
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Lena Bornhoft
Physiotherapist, PhD
Principal Investigators
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Lena Bornhöft, PhD
Role: PRINCIPAL_INVESTIGATOR
Region Västra Götaland, University of Gothenburg
Locations
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Närhälsan Biskopsgården Health centre
Gothenburg, , Sweden
Countries
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References
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Bornhoft L, Arvidsson D, Bergenheim A, Borjesson M, Fridolfsson J, Hellgren M, Nordeman L, Larsson MEH. Function-based risk reduction intervention for lifestyle-related disorders among inactive 40-year-old people: a pilot randomised controlled trial. BMC Public Health. 2024 Oct 13;24(1):2799. doi: 10.1186/s12889-024-20301-6.
Bornhoft L, Arvidsson D, Bergenheim A, Borjesson M, Fridolfsson J, Hellgren M, Nordeman L, Larsson ME. Development and feasibility of a function-based preventive intervention for lifestyle-related disorders. BMC Public Health. 2024 Mar 4;24(1):681. doi: 10.1186/s12889-024-18017-8.
Other Identifiers
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VGFOUREG-968488
Identifier Type: -
Identifier Source: org_study_id
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