Clinical trial NCT05535296: Prevention of Lifestyle-related Ill-health With Early Functional Examinations and Individualized Risk Profiles
Official title: Prevention of Lifestyle-related Ill-health With Early Examinations of Health and Function and Individualized Risk Profiles (PREFUNKTION), a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lifestyle Risk Reduction
Keywords: Prevention
Lifesyle-related condition
Physical function
Physical activity
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
name: Region Värmland, Sweden
First posted: 2022-09-10
Enrollment: 27
Sex: ALL
Minimum age (years): 39
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity level
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Participant feedback
timeFrame: Measured at 3-4 month follow-up.
Secondary outcomes:
measure: Participant feedback functional tests-Borg inclusion
timeFrame: Measured at inclusion.
measure: Participant feedback functional tests-Borg follow-up
timeFrame: Measured at 3-4 month follow-up.
measure: Participant feedback functional tests-instructions
timeFrame: Measured at inclusion.
measure: Participant feedback - descriptive inclusion
timeFrame: Recorded at inclusion.
measure: Participant feedback - descriptive follow-up
timeFrame: Recorded at 3-4 month follow-up.
measure: Risk levels
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Goal achievement
timeFrame: 3-4 month follow-up
measure: Ekblom-Bak fitness test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: 2-minute step test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Body mass index
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Waist circumference
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Handgrip strength
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: 30-second biceps test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Unilateral heel rise test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: 30-second chair stand test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Plank test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Sorenson's back extension test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Supine bridge test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Stand-on-one-leg eyes-open test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Stand-on-one-leg eyes-closed test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Sharpened Romberg
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Functional Reach test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Lateral Reach test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Navicular Drop test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Occiput-to-wall test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Patella mobility
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Sit-rise test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Fingertip-floor test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Lateral flexion test
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Beighton's hypermobility score
timeFrame: Measured at inclusion.
measure: Number of pain locations
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Health-related quality of life
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Self-reported physical activity_SGPALS
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Self-reported physical activity_SNBHW
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Sedentary time
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Risk for developing long-term musculoskeletal disorders
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Blood pressure
timeFrame: Change between inclusion and 3-4 month follow-up.
measure: Blood tests
timeFrame: Change between inclusion and 3-4 month follow-up.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Närhälsan Biskopsgården Health centre
Study officials:
affiliation: Region Västra Götaland, University of Gothenburg
name: Lena Bornhöft, PhD
role: PRINCIPAL_INVESTIGATOR
References: