Prevention of Lifestyle-related Disorders Based on Functional Examinations

Lifestyle-related Condition Clinical Trial

— PREVFUNKTION  

Official title:

Prevention of Lifestyle-related Disorders With Early Examinations of Health and Function and Individualised Functional Profiles - a Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06309342
• Other study ID #: VGRFOU-278257
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Göteborg University
• Contact: Lena Bornhöft, PhD
• Phone: +46761408320
• Email: lena.bornhoft[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 39 Years to 40 Years

Eligibility

Inclusion Criteria:

• 40 years of age

• Relatively normal general mobility - can walk without support and have no self-reported difficulties with using all four extremities - in order to be able to perform standardised functional performance tests.

• Self-assessed as physically inactive (level 1 or 2 on the Saltin Grimby Physical Activity Level Scale) as inactive people stand to gain most from this intervention.

Exclusion Criteria:

• Verbally self-reported physical activity at level three or four on Saltin Grimby Physical Activity Level Scale.

• Severe mental illness or intellectual impairment, as participants will be expected to fill out questionnaires and should have the ability to follow healthcare advice independently should they choose to do so.

• Pregnancy and/or on-going treatment requiring hospital-based services, to increase probability of baseline values which reflect usual capacity.

• No language restrictions are planned but participants needing interpreter help should arrange this themselves.

Related Conditions & MeSH terms

• Lifestyle-related Condition

Intervention

Other:
• PREVFUNKTION
Functional profile and advice concerning cardiovascular fitness level, strength, mobility, balance and posture. Motivational interview and support in goalsetting to make lifestyle changes.
• Control
Physical activity measured with accelerometers. Functional examination. Medical examination and advice concerning weight measures, blood pressure and standard blood tests.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Lena Bornhoft	Göteborg University, Vastra Gotaland Region

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Change in motivation level	Motivation to make lifestyle changes to improve health on an 11-point numerical rating scale.	Change between baseline and 1-year follow-up
Secondary	Proportion achieved goals	Proportion of goals achieved of the goals set by the intervention group at baseline	Measured only at 1-year follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in handgrip strength	Measured with Jamar handdynamometer (kg)	Change between baseline and 1-year follow-up
Secondary	Change in biceps strength	Measured with 30-second biceps test (number repetitions)	Change between baseline and 1-year follow-up
Secondary	Change in leg strength	Measured with 30-second chair-stand test (number repetitions)	Change between baseline and 1-year follow-up
Secondary	Change in calf strength	Measured with single-foot heel rises (number repetitions)	Change between baseline and 1-year follow-up
Secondary	Change in ventral trunk strength	Measured with plank test (seconds)	Change between baseline and 1-year follow-up
Secondary	Change in dorsal trunk strength	Measured with back endurance test (seconds)	Change between baseline and 1-year follow-up
Secondary	Change in lower trunk strength	Measured with supine bridge test (seconds)	Change between baseline and 1-year follow-up
Secondary	Change in static balance - 1	Measured with stand-on-one-leg-eyes-open test (seconds)	Change between baseline and 1-year follow-up
Secondary	Change in static balance - 2	Measured with stand-on-one-leg-eyes-closed test (seconds)	Change between baseline and 1-year follow-up
Secondary	Change in static balance - 3	Measured with sharpened Romberg test (seconds)	Change between baseline and 1-year follow-up
Secondary	Change in dynamic balance	Measured with functional reach test (centimeters)	Change between baseline and 1-year follow-up
Secondary	Change in mobility - 1	Measured with sit-rise test (points)	Change between baseline and 1-year follow-up
Secondary	Change in mobility - 2	Measured with finger-floor test (centimeters)	Change between baseline and 1-year follow-up
Secondary	Change in mobility - 3	Measured with lateral flexion test (centimeters)	Change between baseline and 1-year follow-up
Secondary	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
Secondary	Change in neck mobility	Measured with occiput-to-wall test (points)	Change between baseline and 1-year follow-up
Secondary	Change in foot pronation	Measured with navicular drop test (millimeters)	Change between baseline and 1-year follow-up
Secondary	Change in habitual stance	Measured with patella mobility test (points)	Change between baseline and 1-year follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in number of pain locations	Measured with a pain diagram	Change between baseline and 1-year follow-up
Secondary	Change in proportion smokers	Proportion smokers in each group	Change between baseline and 1-year follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in proportion acceptable blood pressure	Proportion of participants with blood pressure within recommended limits	Change between baseline and 1-year follow-up
Secondary	Change in proportion normal body mass index (BMI)	Proportion of participants with BMI within recommended limits	Change between baseline and 1-year follow-up
Secondary	Change in proportion acceptable waist circumference	Proportion of participants with waist circumference below recommended level	Change between baseline and 1-year follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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