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Prevention of Lifestyle-related Ill-health With Early Functional Examinations and Individualized Risk Profiles (PREVFUNKTION)

L

Lena Bornhoft

Status

Completed

Conditions

Lifestyle Risk Reduction

Treatments

Behavioral: Risk profile

Study type

Interventional

Funder types

Other

Identifiers

NCT05535296
VGFOUREG-968488

Details and patient eligibility

About

Background: Many lifestyle-related health disorders are influenced by physical activity level and physical function. Health examinations which focus on musculoskeletal function of people who have risk factors for lifestyle-related disorders, combined with person-centered advice based on risk profiles can give people knowledge and guidance to manage their own lifestyle priorities.

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.

Enrollment

27 patients

Sex

All

Ages

39 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Born 1982 (aged 40 years). Self-assessed as physically inactive. Self-reported normal general mobility - can walk without support and has full use of all 4 extremities.

Exclusion criteria

  • Self-reported regular moderate-to-intensive physical activity more than once per week. Pregnancy. Ongoing treatment requiring hospital-based services. Severe mental illness or intellectual impairment. Need of interpreter to participate in the study or answer the questionnaires.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

27 participants in 2 patient groups

Intervention group
Experimental group
Description:
Standard health examination and related feedback. Functional examination. Risk profile and related advice.
Treatment:
Behavioral: Risk profile
Control group
No Intervention group
Description:
Standard health examination and related feedback. Functional examination.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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