Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vastra Gotaland Region | OTHER_GOV |
| Göteborg University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREVFUNKTION | Experimental | 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. |
|
| Control | Active Comparator | Medical examination. Functional examination. Measurement of physical activity. Questionnaires on health, function and lifestyle. Feedback and advice based on medical examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREVFUNKTION | Other | Functional profile and advice concerning cardiovascular fitness level, strength, mobility, balance and posture. Motivational interview and support in goalsetting to make lifestyle changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in objectively measured physical activity | Mean daily minutes in moderate-to-very vigorous physical activity measured with accelerometers for 1 week | 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 | Change between baseline and 1-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiovascular fitness | Fitness level measured in ml/kg/min using the Ekblom Bak submaximal ergometer test | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lena Bornhöft, PhD | Contact | +46 761408320 | lena.bornhoft@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Lena Bornhöft, PhD | Region Västra Götaland, University of Gothenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Familjeläkarna i Mölnlycke | Recruiting | Mölnlycke | Region Västra Götaland | 43544 | Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Initial examinations and data collection are made before randomisation. Randomisation then leads to the two groups of participants receiving different amounts of feedback and support. Follow-up examinations and data collection are made after one year in both groups.
Not provided
Not provided
Investigators performing the health and function examinations will not be informed about the group to which the participant is allocated. All examinations are performed identically for participants from both groups.
| Control | Other | Physical activity measured with accelerometers. Functional examination. Medical examination and advice concerning weight measures, blood pressure and standard blood tests. |
|
| 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Change between baseline and 1-year follow-up |
| Change in handgrip strength | Measured with Jamar handdynamometer (kg) | Change between baseline and 1-year follow-up |
| Change in biceps strength | Measured with 30-second biceps test (number repetitions) | Change between baseline and 1-year follow-up |
| Change in leg strength | Measured with 30-second chair-stand test (number repetitions) | Change between baseline and 1-year follow-up |
| Change in calf strength | Measured with single-foot heel rises (number repetitions) | Change between baseline and 1-year follow-up |
| Change in ventral trunk strength | Measured with plank test (seconds) | Change between baseline and 1-year follow-up |
| Change in dorsal trunk strength | Measured with back endurance test (seconds) | Change between baseline and 1-year follow-up |
| Change in lower trunk strength | Measured with supine bridge test (seconds) | Change between baseline and 1-year follow-up |
| Change in static balance - 1 | Measured with stand-on-one-leg-eyes-open test (seconds) | Change between baseline and 1-year follow-up |
| Change in static balance - 2 | Measured with stand-on-one-leg-eyes-closed test (seconds) | Change between baseline and 1-year follow-up |
| Change in static balance - 3 | Measured with sharpened Romberg test (seconds) | Change between baseline and 1-year follow-up |
| Change in dynamic balance | Measured with functional reach test (centimeters) | Change between baseline and 1-year follow-up |
| Change in mobility - 1 | Measured with sit-rise test (points) | Change between baseline and 1-year follow-up |
| Change in mobility - 2 | Measured with finger-floor test (centimeters) | Change between baseline and 1-year follow-up |
| Change in mobility - 3 | Measured with lateral flexion test (centimeters) | 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. | Change between baseline and 1-year follow-up |
| Change in neck mobility | Measured with occiput-to-wall test (points) | Change between baseline and 1-year follow-up |
| Change in foot pronation | Measured with navicular drop test (millimeters) | Change between baseline and 1-year follow-up |
| Change in habitual stance | Measured with patella mobility test (points) | 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. | 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. | 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. | 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. | 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. | 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. | Change between baseline and 1-year follow-up |
| Change in number of pain locations | Measured with a pain diagram | Change between baseline and 1-year follow-up |
| Change in proportion smokers | Proportion smokers in each group | 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) | 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) | 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) | Change between baseline and 1-year follow-up |
| Change in proportion acceptable blood pressure | Proportion of participants with blood pressure within recommended limits | Change between baseline and 1-year follow-up |
| Change in proportion normal body mass index (BMI) | Proportion of participants with BMI within recommended limits | Change between baseline and 1-year follow-up |
| Change in proportion acceptable waist circumference | Proportion of participants with waist circumference below recommended level | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | Change between baseline and 1-year follow-up |