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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lifestyle Risk Reduction

Intervention / Treatment
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* Behavioral: Risk profile


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 39 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Standard health examination and related feedback. Functional examination. Risk profile and related advice. | Behavioral: Risk profile<br>* 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.<br>|
| No Intervention: Control group<br>Standard health examination and related feedback. Functional examination. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity level | Mean number of daily minutes in moderate-to-intensive physical activity measured with accelerometers during one week. | Change between inclusion and 3-4 month follow-up. | 
| Participant feedback | 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. | Measured at 3-4 month follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant feedback functional tests-Borg 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. | Measured at inclusion. | 
| Participant feedback functional tests-Borg 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. | Measured at 3-4 month follow-up. | 
| Participant feedback functional tests-instructions | 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. | Measured at inclusion. | 
| Participant feedback - descriptive inclusion | Voluntary subjective impressions of the intervention | Recorded at inclusion. | 
| Participant feedback - descriptive follow-up | Voluntary subjective impressions of the intervention | Recorded at 3-4 month follow-up. | 
| Risk levels | Change in risk levels on the risk profile. | Change between inclusion and 3-4 month follow-up. | 
| Goal achievement | Proportion of goals set at inclusion achieved. | 3-4 month follow-up | 
| Ekblom-Bak fitness test | Measured as VO2-max in ml/kg/min where higher values indicate better fitness level. | Change between inclusion and 3-4 month follow-up. | 
| 2-minute step test | Measured with number of steps, where higher values indicate better fitness level. | Change between inclusion and 3-4 month follow-up. | 
| Body mass index | Calculated by weight in kg divided by squared height in meters. | Change between inclusion and 3-4 month follow-up. | 
| Waist circumference | Measured in centimeters with measuring tape. | Change between inclusion and 3-4 month follow-up. | 
| Handgrip strength | Measured with Jamar dynamometer, with higher numbers indicating greater strength. | Change between inclusion and 3-4 month follow-up. | 
| 30-second biceps test | Measured by maximum number of repetitions with 2 kg (women) or 4 kg (men) dumbbell during 30 seconds, with higher numbers indicating greater strength. | Change between inclusion and 3-4 month follow-up. | 
| Unilateral heel rise test | Measured with maximum number of repetitions per leg, with higher numbers indicating greater strength. | Change between inclusion and 3-4 month follow-up. | 
| 30-second chair stand test | Measured with maximum number of repetitions during 30 seconds, with higher numbers indicating greater strength. | Change between inclusion and 3-4 month follow-up. | 
| Plank test | Measured with maximum endurance time, with longer time indicating better trunk strength. | Change between inclusion and 3-4 month follow-up. | 
| Sorenson's back extension test | Measured with maximum endurance time, with longer time indicating better trunk strength. | Change between inclusion and 3-4 month follow-up. | 
| Supine bridge test | Measured with maximum endurance time, with longer time indicating better trunk strength. | Change between inclusion and 3-4 month follow-up. | 
| Stand-on-one-leg eyes-open test | Measured with maximum endurance time, with higher numbers indicating better balance. | Change between inclusion and 3-4 month follow-up. | 
| Stand-on-one-leg eyes-closed test | Measured with maximum endurance time, with higher numbers indicating better balance. | Change between inclusion and 3-4 month follow-up. | 
| Sharpened Romberg | Measured with maximum endurance time, with higher numbers indicating better balance. | Change between inclusion and 3-4 month follow-up. | 
| Functional Reach test | Measured with reach limit in centimeters, with higher numbers indicating better balance. | Change between inclusion and 3-4 month follow-up. | 
| Lateral Reach test | Measured with reach limit in centimeters, with higher numbers indicating better balance. | Change between inclusion and 3-4 month follow-up. | 
| Navicular Drop test | Measured as drop distance in millimeters, with higher numbers indicating higher dgree of pronation. | Change between inclusion and 3-4 month follow-up. | 
| Occiput-to-wall test | Measured as contact or no contact between head and wall. | Change between inclusion and 3-4 month follow-up. | 
| Patella mobility | Measured as locked or not locked patella in habitual standing position. | Change between inclusion and 3-4 month follow-up. | 
| Sit-rise test | Measured as points on 0-10 scale, with higher numbers indicating better mobility. | Change between inclusion and 3-4 month follow-up. | 
| Fingertip-floor test | Measured as distance in centimeters, with higher numbers indicating lower mobility. | Change between inclusion and 3-4 month follow-up. | 
| Lateral flexion test | Measured as distance in millimeters, with higher numbers indicating better mobility. | Change between inclusion and 3-4 month follow-up. | 
| Beighton's hypermobility score | Measured on 0 to 9 scale with higher numbers indicating higher level of hypermobility | Measured at inclusion. | 
| Number of pain locations | Change in number of pain locations on pain diagram. | Change between inclusion and 3-4 month follow-up. | 
| Health-related quality of life | Measured with Euroqol-5 dimensions, 5 questions and 0-100 barometer. Higher scores indicate better quality of life. | Change between inclusion and 3-4 month follow-up. | 
| Self-reported physical activity_SGPALS | Measured with Saltin-Grimby Physical Activity Level Scale (0 to 4 descriptive levels). Higher levels indicate more physically active. | Change between inclusion and 3-4 month follow-up. | 
| Self-reported physical activity_SNBHW | 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. | Change between inclusion and 3-4 month follow-up. | 
| Sedentary time | Measured with the SED-GIH question on time sitting still (7 levels from almost always to never). Higher levels indicate more physically active. | Change between inclusion and 3-4 month follow-up. | 
| Risk for developing long-term musculoskeletal disorders | Measured with the Örebro Musculoskeletal Pain Screening Questionnaire (10 questions, max 100 points, higher values indicate increased risk for longterm pain. | Change between inclusion and 3-4 month follow-up. | 
| Blood pressure | Change in blood pressure. | Change between inclusion and 3-4 month follow-up. | 
| Blood tests | 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). | Change between inclusion and 3-4 month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Lifesyle-related condition, Physical function, Physical activity