Prevention of Lifestyle-related Disorders With Early Examinations of Health and Function and Individualised Functional Profiles - a Randomised Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lifestyle-related Condition
- Sponsor
- Lena Bornhoft
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Change in objectively measured physical activity
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed 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.
Investigators
Lena Bornhoft
Research and development leader
Göteborg University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in objectively measured physical activity
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
Change in objectively measured sedentary behaviour
Time Frame: Change between baseline and 1-year follow-up
Mean daily minutes of sedentary behaviour measured with accelerometers for 1 week
Secondary Outcomes
- Proportion achieved goals(Measured only at 1-year follow-up)
- Change in fitness level(Change between baseline and 1-year follow-up)
- Change in strength trunk muscles(Change between baseline and 1-year follow-up)
- Change in cardiovascular fitness(Change between baseline and 1-year follow-up)
- Change in motivation level(Change between baseline and 1-year follow-up)
- Change in strength upper extremity(Change between baseline and 1-year follow-up)
- Change in strength lower extremity(Change between baseline and 1-year follow-up)
- Change in balance(Change between baseline and 1-year follow-up)
- Change in mobility(Change between baseline and 1-year follow-up)
- Change in posture(Change between baseline and 1-year follow-up)
- Change in dorsal trunk strength(Change between baseline and 1-year follow-up)
- Change in weight measures(Change between baseline and 1-year follow-up)
- Change in biceps strength(Change between baseline and 1-year follow-up)
- Change in neck mobility(Change between baseline and 1-year follow-up)
- Change in health-related quality of life assessed with EQ5D index(Change between baseline and 1-year follow-up)
- Change in self-reported physical activity assessed with Swedish questionnaire(Change between baseline and 1-year follow-up)
- Change in self-reported sedentary time(Change between baseline and 1-year follow-up)
- Change in number of pain locations(Change between baseline and 1-year follow-up)
- Change in proportion acceptable level blood glucose(Change between baseline and 1-year follow-up)
- Change in proportion acceptable level triglycerides(Change between baseline and 1-year follow-up)
- Change in proportion acceptable blood pressure(Change between baseline and 1-year follow-up)
- Change in proportion acceptable waist circumference(Change between baseline and 1-year follow-up)
- Change in stress symptoms assessed with Stress and Crisis Inventory-93(Change between baseline and 1-year follow-up)
- Change in static balance - 1(Change between baseline and 1-year follow-up)
- Change in pain(Change between baseline and 1-year follow-up)
- Change in physical activity(Change between baseline and 1-year follow-up)
- Change in handgrip strength(Change between baseline and 1-year follow-up)
- Change in leg strength(Change between baseline and 1-year follow-up)
- Change in calf strength(Change between baseline and 1-year follow-up)
- Change in ventral trunk strength(Change between baseline and 1-year follow-up)
- Change in lower trunk strength(Change between baseline and 1-year follow-up)
- Change in static balance - 2(Change between baseline and 1-year follow-up)
- Change in static balance - 3(Change between baseline and 1-year follow-up)
- Change in dynamic balance(Change between baseline and 1-year follow-up)
- Change in mobility - 1(Change between baseline and 1-year follow-up)
- Change in health-related quality of life assessed with EQ5D VAS(Change between baseline and 1-year follow-up)
- Change in self-reported physical activity assessed with Saltin Grimby Physical Activity Level Scale (SGPALS)(Change between baseline and 1-year follow-up)
- Change in mobility - 2(Change between baseline and 1-year follow-up)
- Change in foot pronation(Change between baseline and 1-year follow-up)
- Change in habitual stance(Change between baseline and 1-year follow-up)
- Change in mobility - 3(Change between baseline and 1-year follow-up)
- Change in hypermobility score(Change between baseline and 1-year follow-up)
- Change in risk for chronic pain and sickness absence assessed with Örebro Musculoskeletal Pain Screening Questionnaire(Change between baseline and 1-year follow-up)
- Change in proportion smokers(Change between baseline and 1-year follow-up)
- Change in proportion acceptable level serum cholesterol(Change between baseline and 1-year follow-up)
- Correlation between self-assessed and objectively measured fitness - 2(Change between baseline and 1-year follow-up)
- Change in relative physical activity(Change between baseline and 1-year follow-up)
- Change in proportion normal body mass index (BMI)(Change between baseline and 1-year follow-up)
- Change in depression and anxiety symptoms assessed with Hospital Anxiety and Depression Scale(Change between baseline and 1-year follow-up)
- Correlation between self-assessed and objectively measured fitness(Change between baseline and 1-year follow-up)
- Correlation between self-assessed and objectively measured strength upper extremity(Change between baseline and 1-year follow-up)
- Correlation between self-assessed and objectively measured physical activity(Change between baseline and 1-year follow-up)
- Change in sufficient physical activity(Change between baseline and 1-year follow-up)
- Correlation between self-assessed and objectively measured strength lower extremity(Change between baseline and 1-year follow-up)
- Correlation between self-assessed and objectively measured balance(Change between baseline and 1-year follow-up)
- Correlation between self-assessed and objectively measured physical activity - 2(Change between baseline and 1-year follow-up)