An interventional study of PREVFUNKTION and Control in Lifestyle-related Condition, sponsored by Lena Bornhoft. Active, not recruiting at 2 sites in Sweden. Open to participants aged 39 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Lena Bornhoft · Not applicable, Interventional, and Prevention
The goal of this randomised controlled trial is to examine the effects of functional examinations and feedback/support on healthy 40-year-olds. The main questions it aims to answer are: • Does feedback and motivational interviewing after testing physical function motivate inactive middle-aged people to increase their physical activity level? • Does the intervention lead to health benefits over time - less pain, better function, higher health-related quality of life, fewer risk factors for lifestyle-related illness? Participants will: • undergo medical and functional health examinations, • their physical activity level will be measured, • receive feedback and advice based on both parts of the examinations, • receive a functional profile, • be supported in goalsetting for lifestyle changes. Researchers will compare with a control group who, after the examinations, receive feedback only from the medical examination to see if participants become more physically active, achieve better function, become more motivated to make lifestyle changes, reduce risk factors for lifestyle-related illness, achieve health benefits and better health-related quality of life.
Relatively healthy 40-year-olds will be examined at baseline and 1 year with both standard medical and newly developed functional examinations and physical activity level will be measured with accelerometers. The intervention group will receive feedback on all their results. A functional profile will be compiled and explained to each participant and they will receive support in setting relevant goals for lifestyle changes and making realistic plans to achieve them. The control group will also be examined as above but will receive feedback and advice based only on the standard medical examination.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's planned enrollment of 250 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
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Exclusion Criteria:
Medical examination. Functional examination. Measurement of physical activity. Questionnaires on health, function and lifestyle. Feedback and advice based on medical examination. Feedback and advice based on functional examination. Functional profile. Support in setting goals for lifestyle changes.
Other: PREVFUNKTION · Other: Control
Medical examination. Functional examination. Measurement of physical activity. Questionnaires on health, function and lifestyle. Feedback and advice based on medical examination.
Other: Control
Functional profile and advice concerning cardiovascular fitness level, strength, mobility, balance and posture. Motivational interview and support in goalsetting to make lifestyle changes.
Physical activity measured with accelerometers. Functional examination. Medical examination and advice concerning weight measures, blood pressure and standard blood tests.
Change in objectively measured physical activity
Mean daily minutes in moderate-to-very vigorous physical activity measured with accelerometers for 1 week
Time frame: Change between baseline and 1-year follow-up
Change in objectively measured sedentary behaviour
Mean daily minutes of sedentary behaviour measured with accelerometers for 1 week
Time frame: Change between baseline and 1-year follow-up
Change in cardiovascular fitness
Fitness level measured in ml/kg/min using the Ekblom Bak submaximal ergometer test
Time frame: Change between baseline and 1-year follow-up
Change in motivation level
Motivation to make lifestyle changes to improve health on an 11-point numerical rating scale.
Time frame: Change between baseline and 1-year follow-up
Proportion achieved goals
Proportion of goals achieved of the goals set by the intervention group at baseline
Time frame: Measured only at 1-year follow-up
Change in fitness level
Point level on the study-specific functional profile arm for fitness where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better fitness level.
Time frame: Change between baseline and 1-year follow-up
Change in strength upper extremity
Point level on the study-specific functional profile arm for strength upper extremity where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better strength.
Time frame: Change between baseline and 1-year follow-up
Change in strength lower extremity
Point level on the study-specific functional profile arm for strength lower extremity where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better strength.
Time frame: Change between baseline and 1-year follow-up
Change in strength trunk muscles
Point level on the study-specific functional profile arm for strength trunk where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better strength.
Time frame: Change between baseline and 1-year follow-up
Change in balance
Point level on the study-specific functional profile arm for balance where points are given for grade of deviation from norm. Minimum -2, maximum +2. Higher scores indicate better balance.
Time frame: Change between baseline and 1-year follow-up
Change in mobility
Point level on the study-specific functional profile arm for mobility where points are given for grade of deviation from norm. Minimum -2, maximum 0. Lower score indicates mobility dysfunction, 0 indicates normal mobility.
Time frame: Change between baseline and 1-year follow-up
Change in posture
Point level on the study-specific functional profile arm for posture where points are given for grade of deviation from norm. Minimum -1, maximum 0. Lower score indicates postural deviations, 0 indicates normal postural measurements.
Time frame: Change between baseline and 1-year follow-up
Change in weight measures
Point level on the study-specific functional profile arm for weight where points are given for grade of deviation from recommended values. Minimum -2, maximum 0. Lower score indicates overweight (or underweight), 0 indicates normal weight.
Time frame: Change between baseline and 1-year follow-up
Change in pain
Point level on the study-specific functional profile arm for pain where points are given for number of pain locations, score on the Örebro Musculoskeletal Pain Screening Questionnaire and on the pain question on Euroqol-5 dimensions-3 levels. Minimum -2, maximum 0. Lower score indicates more pain, 0 indicates no pain.
Time frame: Change between baseline and 1-year follow-up
Change in physical activity
Point level on the study-specific functional profile arm for physical activity where points are given for grade of deviation from recommended values when objectively measured with accelerometers. Minimum -2, maximum +2. Increased point value indicates higher physical activity level.
Time frame: Change between baseline and 1-year follow-up
Change in handgrip strength
Measured with Jamar handdynamometer (kg)
Time frame: Change between baseline and 1-year follow-up
Change in biceps strength
Measured with 30-second biceps test (number repetitions)
Time frame: Change between baseline and 1-year follow-up
Change in leg strength
Measured with 30-second chair-stand test (number repetitions)
Time frame: Change between baseline and 1-year follow-up
Change in calf strength
Measured with single-foot heel rises (number repetitions)
Time frame: Change between baseline and 1-year follow-up
Change in ventral trunk strength
Measured with plank test (seconds)
Time frame: Change between baseline and 1-year follow-up
Change in dorsal trunk strength
Measured with back endurance test (seconds)
Time frame: Change between baseline and 1-year follow-up
Change in lower trunk strength
Measured with supine bridge test (seconds)
Time frame: Change between baseline and 1-year follow-up
Change in static balance - 1
Measured with stand-on-one-leg-eyes-open test (seconds)
Time frame: Change between baseline and 1-year follow-up
Change in static balance - 2
Measured with stand-on-one-leg-eyes-closed test (seconds)
Time frame: Change between baseline and 1-year follow-up
Change in static balance - 3
Measured with sharpened Romberg test (seconds)
Time frame: Change between baseline and 1-year follow-up
Change in dynamic balance
Measured with functional reach test (centimeters)
Time frame: Change between baseline and 1-year follow-up
Change in mobility - 1
Measured with sit-rise test (points)
Time frame: Change between baseline and 1-year follow-up
Change in mobility - 2
Measured with finger-floor test (centimeters)
Time frame: Change between baseline and 1-year follow-up
Change in mobility - 3
Measured with lateral flexion test (centimeters)
Time frame: Change between baseline and 1-year follow-up
Change in hypermobility score
Measured with Beighton hypermobility score with point values between 0 and 9 where score over 4 indicate general hypermobility.
Time frame: Change between baseline and 1-year follow-up
Change in neck mobility
Measured with occiput-to-wall test (points)
Time frame: Change between baseline and 1-year follow-up
Change in foot pronation
Measured with navicular drop test (millimeters)
Time frame: Change between baseline and 1-year follow-up
Change in habitual stance
Measured with patella mobility test (points)
Time frame: Change between baseline and 1-year follow-up
Change in health-related quality of life assessed with EQ5D index
Measured with index values for Euroqol-5 dimensions-3 levels. Minimum -0.59, maximum +1. Higher scores indicate better health-related quality of life.
Time frame: Change between baseline and 1-year follow-up
Change in health-related quality of life assessed with EQ5D VAS
Measured with the 100-point barometer for Euroqol-5 dimensions-3 levels. Minimum 0, maximum 100. Higher scores indicate better health-related quality of life.
Time frame: Change between baseline and 1-year follow-up
Change in self-reported physical activity assessed with Swedish questionnaire
Measured with Swedish National Board of Health and Welfare questionnaire with 2 questions on physical activity and exercise measured in minutes. Minimum 0, maximum measured value 540. Increasing values indicate higher levels of physical activity.
Time frame: Change between baseline and 1-year follow-up
Change in self-reported physical activity assessed with Saltin Grimby Physical Activity Level Scale (SGPALS)
Measured with SGPALS with point values between 1 and 4 where increasing values indicate higher level of physical activity.
Time frame: Change between baseline and 1-year follow-up
Change in self-reported sedentary time
Measured in hours per day with SED-GIH questionnaire with values between 0 and 24 where increasing sedentary time is considered to have a negative impact on health.
Time frame: Change between baseline and 1-year follow-up
Change in risk for chronic pain and sickness absence assessed with Örebro Musculoskeletal Pain Screening Questionnaire
Measured with Örebro Musculoskeletal Pain Screening Questionnaire with scores between 1 and 100 where increasing values indicate higher risk for chronic pain and sickness absence.
Time frame: Change between baseline and 1-year follow-up
Change in number of pain locations
Measured with a pain diagram
Time frame: Change between baseline and 1-year follow-up
Change in proportion smokers
Proportion smokers in each group
Time frame: Change between baseline and 1-year follow-up
Change in proportion acceptable level blood glucose
Proportion with blood glucose levels within recommended limits (4.0-6.0 mmol/L)
Time frame: Change between baseline and 1-year follow-up
Change in proportion acceptable level serum cholesterol
Proportion with cholesterol levels within recommended limits (3.3-6.9 mmol/L)
Time frame: Change between baseline and 1-year follow-up
Change in proportion acceptable level triglycerides
Proportion with triglyceride levels within recommended limits (0,45-2.6)
Time frame: Change between baseline and 1-year follow-up
Change in proportion acceptable blood pressure
Proportion of participants with blood pressure within recommended limits
Time frame: Change between baseline and 1-year follow-up
Change in proportion normal body mass index (BMI)
Proportion of participants with BMI within recommended limits
Time frame: Change between baseline and 1-year follow-up
Change in proportion acceptable waist circumference
Proportion of participants with waist circumference below recommended level
Time frame: Change between baseline and 1-year follow-up
Change in stress symptoms assessed with Stress and Crisis Inventory-93
Measured with Stress and Crisis Inventory-93 questionnaire. Minimum 0, maximum 140, with higher values indicating higher stress levels.
Time frame: Change between baseline and 1-year follow-up
Change in depression and anxiety symptoms assessed with Hospital Anxiety and Depression Scale
Measured with Hospital Anxiety and Depression Scale. Minimum 0, maximum 42 with 21 as maximum for anxiety and 21 maximum for depression. Increasing values indicate more severe symptoms.
Time frame: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured fitness
Correlation between fitness self-assessed on a 5-point Likert scale and point value on the fitness arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Time frame: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured fitness - 2
Correlation between fitness self-assessed on a 5-point Likert scale and fitness grade on the Ekblom Bak fitness test (5 point Likert scale). Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Time frame: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured strength upper extremity
Correlation between upper extremity strength self-assessed on a 5-point Likert scale and point value for the strength upper extremity arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Time frame: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured strength lower extremity
Correlation between lower extremity strength self-assessed on a 5-point Likert scale and point value for the strength lower extremity arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Time frame: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured balance
Correlation between balance self-assessed on a 5-point Likert scale and point value on the balance arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Time frame: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured physical activity
Correlation between self-assessed walking ability on a 5-point Likert scale and point value on the physical activity arm on the study-specific functional profile. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Time frame: Change between baseline and 1-year follow-up
Correlation between self-assessed and objectively measured physical activity - 2
Correlation between self-assessed walking ability on a 5-point Likert scale and number of daily minutes in moderate-to-very vigorous physical activity measured with accelerometers. Minimum -1, maximum +1. Higher values indicate better correlation between the 2 measures.
Time frame: Change between baseline and 1-year follow-up
Change in relative physical activity
Mean daily minutes of moderate-to-very vigorous physical activity measured with accelerometers for 1 week where moderate is individually calculated in relation to fitness level (46% of VO2max).
Time frame: Change between baseline and 1-year follow-up
Change in sufficient physical activity
Number of mean daily minutes of physical activity measured with accelerometers for 1 week above a known health-promoting level based on a fitness level of 31.5 ml/kg for women and 35 ml/kg for men.
Time frame: Change between baseline and 1-year follow-up
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Lena Bornhoft