Familjeläkarna i Mölnlycke
Mölnlycke, Region Västra Götaland, 43544, Sweden
Location status: Recruiting
Location contact
Camilla Olofsson
CONTACT
Kinna Helgesson
CONTACT
Lena Bornhöft, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06309342
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.
Interested in participating?
Request Info39 year–40 year
All sexes
Interventional
Not applicable
Mölnlycke, Region Västra Götaland, 43544, Sweden
Location status: Recruiting
Camilla Olofsson
CONTACT
Kinna Helgesson
CONTACT
Lena Bornhöft, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Change between baseline and 1-year follow-up
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
Mean daily minutes of sedentary behaviour measured with accelerometers for 1 week
Time frame: Change between baseline and 1-year follow-up
Fitness level measured in ml/kg/min using the Ekblom Bak submaximal ergometer test
Time frame: Change between baseline and 1-year follow-up
Motivation to make lifestyle changes to improve health on an 11-point numerical rating scale.
Time frame: Measured only at 1-year follow-up
Proportion of goals achieved of the goals set by the intervention group at baseline
Time frame: Change between baseline and 1-year follow-up
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
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
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
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
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
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
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
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
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
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
Measured with Jamar handdynamometer (kg)
Time frame: Change between baseline and 1-year follow-up
Measured with 30-second biceps test (number repetitions)
Time frame: Change between baseline and 1-year follow-up
Measured with 30-second chair-stand test (number repetitions)
Time frame: Change between baseline and 1-year follow-up
Measured with single-foot heel rises (number repetitions)
Time frame: Change between baseline and 1-year follow-up
Measured with plank test (seconds)
Time frame: Change between baseline and 1-year follow-up
Measured with back endurance test (seconds)
Time frame: Change between baseline and 1-year follow-up
Measured with supine bridge test (seconds)
Time frame: Change between baseline and 1-year follow-up
Measured with stand-on-one-leg-eyes-open test (seconds)
Time frame: Change between baseline and 1-year follow-up
Measured with stand-on-one-leg-eyes-closed test (seconds)
Time frame: Change between baseline and 1-year follow-up
Measured with sharpened Romberg test (seconds)
Time frame: Change between baseline and 1-year follow-up
Measured with functional reach test (centimeters)
Time frame: Change between baseline and 1-year follow-up
Measured with sit-rise test (points)
Time frame: Change between baseline and 1-year follow-up
Measured with finger-floor test (centimeters)
Time frame: Change between baseline and 1-year follow-up
Measured with lateral flexion test (centimeters)
Time frame: Change between baseline and 1-year follow-up
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
Measured with occiput-to-wall test (points)
Time frame: Change between baseline and 1-year follow-up
Measured with navicular drop test (millimeters)
Time frame: Change between baseline and 1-year follow-up
Measured with patella mobility test (points)
Time frame: Change between baseline and 1-year follow-up
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
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
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
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
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
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
Measured with a pain diagram
Time frame: Change between baseline and 1-year follow-up
Proportion smokers in each group
Time frame: Change between baseline and 1-year follow-up
Proportion with blood glucose levels within recommended limits (4.0-6.0 mmol/L)
Time frame: Change between baseline and 1-year follow-up
Proportion with cholesterol levels within recommended limits (3.3-6.9 mmol/L)
Time frame: Change between baseline and 1-year follow-up
Proportion with triglyceride levels within recommended limits (0,45-2.6)
Time frame: Change between baseline and 1-year follow-up
Proportion of participants with blood pressure within recommended limits
Time frame: Change between baseline and 1-year follow-up
Proportion of participants with BMI within recommended limits
Time frame: Change between baseline and 1-year follow-up
Proportion of participants with waist circumference below recommended level
Time frame: Change between baseline and 1-year follow-up
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
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 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 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 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 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 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 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 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
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
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.
Contact information is provided by the study sponsor or research team.
Lena Bornhoft
Other
Prevention of Lifestyle-related Disorders With Early Examinations of Health and Function and Individualised Functional Profiles - a Randomised Controlled Trial
Acronym: PREVFUNKTION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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