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

Prevention of Lifestyle-related Ill-health With Early Examinations of Health and Function and Individualized Risk Profiles (PREFUNKTION), a Pilot Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05535296
Acronym
PREVFUNKTION
Enrollment
27
Registered
2022-09-10
Start date
2022-08-15
Completion date
2023-04-18
Last updated
2023-07-07

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

Conditions

Lifestyle Risk Reduction

Keywords

Prevention, Lifesyle-related condition, Physical function, Physical activity

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.

Interventions

BEHAVIORALRisk 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.

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Region Värmland, Sweden
CollaboratorUNKNOWN
Lena Bornhoft
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
39 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Physical activity levelChange between inclusion and 3-4 month follow-up.Mean number of daily minutes in moderate-to-intensive physical activity measured with accelerometers during one week.
Participant feedbackMeasured at 3-4 month follow-up.Rating of overall helpfulness of intervention in intervention group on 0 to 5 numerical rating scale ranging between 0=No help at all and 5=Very helpful.

Secondary

MeasureTime frameDescription
Participant feedback functional tests-instructionsMeasured at inclusion.Rating of how understandable the instructions were on a 0 to 5 numerical rating scale where 0 is completely ununderstandable and 5 is very easy to understand.
Participant feedback - descriptive inclusionRecorded at inclusion.Voluntary subjective impressions of the intervention
Participant feedback - descriptive follow-upRecorded at 3-4 month follow-up.Voluntary subjective impressions of the intervention
Risk levelsChange between inclusion and 3-4 month follow-up.Change in risk levels on the risk profile.
Goal achievement3-4 month follow-upProportion of goals set at inclusion achieved.
Ekblom-Bak fitness testChange between inclusion and 3-4 month follow-up.Measured as VO2-max in ml/kg/min where higher values indicate better fitness level.
2-minute step testChange between inclusion and 3-4 month follow-up.Measured with number of steps, where higher values indicate better fitness level.
Body mass indexChange between inclusion and 3-4 month follow-up.Calculated by weight in kg divided by squared height in meters.
Waist circumferenceChange between inclusion and 3-4 month follow-up.Measured in centimeters with measuring tape.
Handgrip strengthChange between inclusion and 3-4 month follow-up.Measured with Jamar dynamometer, with higher numbers indicating greater strength.
30-second biceps testChange between inclusion and 3-4 month follow-up.Measured by maximum number of repetitions with 2 kg (women) or 4 kg (men) dumbbell during 30 seconds, with higher numbers indicating greater strength.
Unilateral heel rise testChange between inclusion and 3-4 month follow-up.Measured with maximum number of repetitions per leg, with higher numbers indicating greater strength.
30-second chair stand testChange between inclusion and 3-4 month follow-up.Measured with maximum number of repetitions during 30 seconds, with higher numbers indicating greater strength.
Plank testChange between inclusion and 3-4 month follow-up.Measured with maximum endurance time, with longer time indicating better trunk strength.
Sorenson's back extension testChange between inclusion and 3-4 month follow-up.Measured with maximum endurance time, with longer time indicating better trunk strength.
Supine bridge testChange between inclusion and 3-4 month follow-up.Measured with maximum endurance time, with longer time indicating better trunk strength.
Stand-on-one-leg eyes-open testChange between inclusion and 3-4 month follow-up.Measured with maximum endurance time, with higher numbers indicating better balance.
Stand-on-one-leg eyes-closed testChange between inclusion and 3-4 month follow-up.Measured with maximum endurance time, with higher numbers indicating better balance.
Participant feedback functional tests-Borg inclusionMeasured at inclusion.Rating of difficulty of individual functional tests on the Borg Rating of Perceived Exertion scale, ranging from 6 to 20 with higher levels indicating higher exertion level.
Functional Reach testChange between inclusion and 3-4 month follow-up.Measured with reach limit in centimeters, with higher numbers indicating better balance.
Lateral Reach testChange between inclusion and 3-4 month follow-up.Measured with reach limit in centimeters, with higher numbers indicating better balance.
Navicular Drop testChange between inclusion and 3-4 month follow-up.Measured as drop distance in millimeters, with higher numbers indicating higher dgree of pronation.
Occiput-to-wall testChange between inclusion and 3-4 month follow-up.Measured as contact or no contact between head and wall.
Patella mobilityChange between inclusion and 3-4 month follow-up.Measured as locked or not locked patella in habitual standing position.
Sit-rise testChange between inclusion and 3-4 month follow-up.Measured as points on 0-10 scale, with higher numbers indicating better mobility.
Fingertip-floor testChange between inclusion and 3-4 month follow-up.Measured as distance in centimeters, with higher numbers indicating lower mobility.
Lateral flexion testChange between inclusion and 3-4 month follow-up.Measured as distance in millimeters, with higher numbers indicating better mobility.
Beighton's hypermobility scoreMeasured at inclusion.Measured on 0 to 9 scale with higher numbers indicating higher level of hypermobility
Number of pain locationsChange between inclusion and 3-4 month follow-up.Change in number of pain locations on pain diagram.
Health-related quality of lifeChange between inclusion and 3-4 month follow-up.Measured with Euroqol-5 dimensions, 5 questions and 0-100 barometer. Higher scores indicate better quality of life.
Self-reported physical activity_SGPALSChange between inclusion and 3-4 month follow-up.Measured with Saltin-Grimby Physical Activity Level Scale (0 to 4 descriptive levels). Higher levels indicate more physically active.
Self-reported physical activity_SNBHWChange between inclusion and 3-4 month follow-up.Measured with the Swedish National Board of Health and Welfare's 2 questions on physical activity (choose from 6 descriptive levels of exercise and 7 descriptive levels of daily activity). Higher levels indicate more physically active.
Sedentary timeChange between inclusion and 3-4 month follow-up.Measured with the SED-GIH question on time sitting still (7 levels from almost always to never). Higher levels indicate more physically active.
Risk for developing long-term musculoskeletal disordersChange between inclusion and 3-4 month follow-up.Measured with the Örebro Musculoskeletal Pain Screening Questionnaire (10 questions, max 100 points, higher values indicate increased risk for longterm pain.
Blood pressureChange between inclusion and 3-4 month follow-up.Change in blood pressure.
Blood testsChange between inclusion and 3-4 month follow-up.Whether or not acceptable levels of serum cholesterol (3.3 to 6.9mmol/L), triglycerides (0.45 to 2.6 mmol/L), LDL-cholesterol (1.4 to 4.7 mmol/L), HDL cholesterol (women 1.0 to 2.7 and men 0.80 to 2.1 mmol/L) and blood glucose (4.0 to 6.0 mmol/L).
Sharpened RombergChange between inclusion and 3-4 month follow-up.Measured with maximum endurance time, with higher numbers indicating better balance.
Participant feedback functional tests-Borg follow-upMeasured at 3-4 month follow-up.Rating of difficulty of individual functional tests on the Borg Rating of Perceived Exertion scale, ranging from 6 to 20 with higher levels indicating higher exertion level.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026