Lifestyle Risk ReductionPREVFUNKTIONNCT05535296
Prevention of Lifestyle-related Ill-health With Early Functional Examinations and Individualized Risk Profiles
A study testing Risk profile in people with Lifestyle Risk Reduction, run by Lena Bornhoft at 1 site in Sweden.
Trial summary
Background: Many lifestyle-related health disorders are influenced by physical activity level and physical function. Health examinations which focus on musculoskeletal function of people who have risk factors for lifestyle-related disorders, combined with person-centered advice based on risk profiles can give people… Read more about this study
- Who is it for?
- Ages 39 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle Risk Reduction
- What is being tested?
- Risk profile
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2022to 18 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Born 1982 (aged 40 years). Self-assessed as physically inactive. Self-reported normal general mobility - can walk without support and has full use of all 4 extremities.
Who cannot join
- Self-reported regular moderate-to-intensive physical activity more than once per week. Pregnancy. Ongoing treatment requiring hospital-based services. Severe mental illness or intellectual impairment. Need of interpreter to participate in the study or answer the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Lifestyle-related Ill-health With Early Examinations of Health and Function and Individualized Risk Profiles (PREFUNKTION), a Pilot Study.
Background: Many lifestyle-related health disorders are influenced by physical activity level and physical function. Health examinations which focus on musculoskeletal function of people who have risk factors for lifestyle-related disorders, combined with person-centered advice based on risk profiles can give people knowledge and guidance to manage their own lifestyle priorities.
Aim: To investigate the feasibility of a protocol for a randomized controlled trial (RCT) which will examine the preventive effects of musculoskeletal function examinations and person-centered advice on inactive middle-aged people.
Read more
Methods: Physically inactive middle-aged people will be invited to participate in a two-part health examination with follow-up after three months in a pilot study. Part 1 is a standard health examination including blood tests and Part 2 is a functional examination of fitness, strength, mobility, balance and posture according to our protocol based on validated tests. The intervention group receives feedback based on both parts of the examination while the control group receives feedback only from Part 1. Physical activity level will be measured objectively with accelerometers at inclusion and follow-up.
Expected results: The pilot study is expected to show whether the planned RCT is practically feasible and to give relevant support for the power analysis for a later full-scale RCT. Better understanding of personal physical function and risk factors can facilitate lifestyle decisions on the individual level which can reduce the risk for later ill-health and need of health-care. Preventive interventions may contribute to reduce the ever-increasing level of lifestyle-related ill-health.
- Conditions
- Lifestyle Risk Reduction
- Being tested
- Risk profile
- Keywords
- Prevention, Lifesyle-related condition, Physical function, Physical activity
- Medical subject headings
- Risk Reduction Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk profileBehavioural
Compiliation of risk profile based on fitness, strength, mobility, balance, posture, physical activity level, weight and pain. Advice based on the above and support in goal-setting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Standard health examination and related feedback. Functional examination. Risk profile and related advice. Receives: Behavioral: Risk profile |
| Control group | No intervention | Standard health examination and related feedback. Functional examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
Mean number of daily minutes in moderate-to-intensive physical activity measured with accelerometers during one week.
Measured: Change between inclusion and 3-4 month follow-up.
Participant feedback
Rating of overall helpfulness of intervention in intervention group on 0 to 5 numerical rating scale ranging between 0=No help at all and 5=Very helpful.
Measured: Measured at 3-4 month follow-up.
Secondary outcomes (38)
Participant feedback functional tests-Borg inclusion
Rating of difficulty of individual functional tests on the Borg Rating of Perceived Exertion scale, ranging from 6 to 20 with higher levels indicating higher exertion level.
Measured: Measured at inclusion.
Participant feedback functional tests-Borg follow-up
Rating of difficulty of individual functional tests on the Borg Rating of Perceived Exertion scale, ranging from 6 to 20 with higher levels indicating higher exertion level.
Measured: Measured at 3-4 month follow-up.
Participant feedback functional tests-instructions
Rating of how understandable the instructions were on a 0 to 5 numerical rating scale where 0 is completely ununderstandable and 5 is very easy to understand.
Measured: Measured at inclusion.
Participant feedback - descriptive inclusion
Voluntary subjective impressions of the intervention
Measured: Recorded at inclusion.
Participant feedback - descriptive follow-up
Voluntary subjective impressions of the intervention
Measured: Recorded at 3-4 month follow-up.
Risk levels
Change in risk levels on the risk profile.
Measured: Change between inclusion and 3-4 month follow-up.
Goal achievement
Proportion of goals set at inclusion achieved.
Measured: 3-4 month follow-up
Ekblom-Bak fitness test
Measured as VO2-max in ml/kg/min where higher values indicate better fitness level.
Measured: Change between inclusion and 3-4 month follow-up.
2-minute step test
Measured with number of steps, where higher values indicate better fitness level.
Measured: Change between inclusion and 3-4 month follow-up.
Body mass index
Calculated by weight in kg divided by squared height in meters.
Measured: Change between inclusion and 3-4 month follow-up.
Waist circumference
Measured in centimeters with measuring tape.
Measured: Change between inclusion and 3-4 month follow-up.
Handgrip strength
Measured with Jamar dynamometer, with higher numbers indicating greater strength.
Measured: Change between inclusion and 3-4 month follow-up.
30-second biceps test
Measured by maximum number of repetitions with 2 kg (women) or 4 kg (men) dumbbell during 30 seconds, with higher numbers indicating greater strength.
Measured: Change between inclusion and 3-4 month follow-up.
Unilateral heel rise test
Measured with maximum number of repetitions per leg, with higher numbers indicating greater strength.
Measured: Change between inclusion and 3-4 month follow-up.
30-second chair stand test
Measured with maximum number of repetitions during 30 seconds, with higher numbers indicating greater strength.
Measured: Change between inclusion and 3-4 month follow-up.
Plank test
Measured with maximum endurance time, with longer time indicating better trunk strength.
Measured: Change between inclusion and 3-4 month follow-up.
Sorenson's back extension test
Measured with maximum endurance time, with longer time indicating better trunk strength.
Measured: Change between inclusion and 3-4 month follow-up.
Supine bridge test
Measured with maximum endurance time, with longer time indicating better trunk strength.
Measured: Change between inclusion and 3-4 month follow-up.
Stand-on-one-leg eyes-open test
Measured with maximum endurance time, with higher numbers indicating better balance.
Measured: Change between inclusion and 3-4 month follow-up.
Stand-on-one-leg eyes-closed test
Measured with maximum endurance time, with higher numbers indicating better balance.
Measured: Change between inclusion and 3-4 month follow-up.
Sharpened Romberg
Measured with maximum endurance time, with higher numbers indicating better balance.
Measured: Change between inclusion and 3-4 month follow-up.
Functional Reach test
Measured with reach limit in centimeters, with higher numbers indicating better balance.
Measured: Change between inclusion and 3-4 month follow-up.
Lateral Reach test
Measured with reach limit in centimeters, with higher numbers indicating better balance.
Measured: Change between inclusion and 3-4 month follow-up.
Navicular Drop test
Measured as drop distance in millimeters, with higher numbers indicating higher dgree of pronation.
Measured: Change between inclusion and 3-4 month follow-up.
Occiput-to-wall test
Measured as contact or no contact between head and wall.
Measured: Change between inclusion and 3-4 month follow-up.
Patella mobility
Measured as locked or not locked patella in habitual standing position.
Measured: Change between inclusion and 3-4 month follow-up.
Sit-rise test
Measured as points on 0-10 scale, with higher numbers indicating better mobility.
Measured: Change between inclusion and 3-4 month follow-up.
Fingertip-floor test
Measured as distance in centimeters, with higher numbers indicating lower mobility.
Measured: Change between inclusion and 3-4 month follow-up.
Lateral flexion test
Measured as distance in millimeters, with higher numbers indicating better mobility.
Measured: Change between inclusion and 3-4 month follow-up.
Beighton's hypermobility score
Measured on 0 to 9 scale with higher numbers indicating higher level of hypermobility
Measured: Measured at inclusion.
Number of pain locations
Change in number of pain locations on pain diagram.
Measured: Change between inclusion and 3-4 month follow-up.
Health-related quality of life
Measured with Euroqol-5 dimensions, 5 questions and 0-100 barometer. Higher scores indicate better quality of life.
Measured: Change between inclusion and 3-4 month follow-up.
Self-reported physical activity_SGPALS
Measured with Saltin-Grimby Physical Activity Level Scale (0 to 4 descriptive levels). Higher levels indicate more physically active.
Measured: Change between inclusion and 3-4 month follow-up.
Self-reported physical activity_SNBHW
Measured with the Swedish National Board of Health and Welfare's 2 questions on physical activity (choose from 6 descriptive levels of exercise and 7 descriptive levels of daily activity). Higher levels indicate more physically active.
Measured: Change between inclusion and 3-4 month follow-up.
Sedentary time
Measured with the SED-GIH question on time sitting still (7 levels from almost always to never). Higher levels indicate more physically active.
Measured: Change between inclusion and 3-4 month follow-up.
Risk for developing long-term musculoskeletal disorders
Measured with the Örebro Musculoskeletal Pain Screening Questionnaire (10 questions, max 100 points, higher values indicate increased risk for longterm pain.
Measured: Change between inclusion and 3-4 month follow-up.
Blood pressure
Change in blood pressure.
Measured: Change between inclusion and 3-4 month follow-up.
Blood tests
Whether or not acceptable levels of serum cholesterol (3.3 to 6.9mmol/L), triglycerides (0.45 to 2.6 mmol/L), LDL-cholesterol (1.4 to 4.7 mmol/L), HDL cholesterol (women 1.0 to 2.7 and men 0.80 to 2.1 mmol/L) and blood glucose (4.0 to 6.0 mmol/L).
Measured: Change between inclusion and 3-4 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start15 Aug 2022
- Primary completion2 Mar 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lifestyle Risk ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lena Bornhoft
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region, Region Värmland, Sweden
- Responsible party
- Sponsor-investigator, Lena Bornhoft, Göteborg University
- Investigators
- Lena Bornhöft, PhD, Principal investigator, Region Västra Götaland, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535296
- Sponsor's protocol ID
- VGFOUREG-968488
- Acronym
- PREVFUNKTION
- Status last verified
- Jul 2023
- First submitted
- 30 Aug 2022
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers than the participating research group.
Publications
Bornhoft L, Arvidsson D, Bergenheim A, Borjesson M, Fridolfsson J, Hellgren M, Nordeman L, Larsson MEH. Function-based risk reduction intervention for lifestyle-related disorders among inactive 40-year-old people: a pilot randomised controlled trial. BMC Public Health. 2024 Oct 13;24(1):2799. doi: 10.1186/s12889-024-20301-6.
PubMed 39396984Bornhoft L, Arvidsson D, Bergenheim A, Borjesson M, Fridolfsson J, Hellgren M, Nordeman L, Larsson ME. Development and feasibility of a function-based preventive intervention for lifestyle-related disorders. BMC Public Health. 2024 Mar 4;24(1):681. doi: 10.1186/s12889-024-18017-8.
PubMed 38438859
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Lifestyle-related Ill-health With Early Examinations of Health and Function and Individualized Risk Profiles (PREFUNKTION), a Pilot Study.
- ClinicalTrials.gov ID
- NCT05535296
- Acronym / sponsor ID
- PREVFUNKTION / VGFOUREG-968488
- Conditions
- Lifestyle Risk Reduction
- Keywords
- Prevention, Lifesyle-related condition, Physical function, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Lena BornhoftUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region, Region Värmland, Sweden
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Many lifestyle-related health disorders are influenced by physical activity level and physical function. Health examinations which focus on musculoskeletal function of people who have risk factors for lifestyle-related disorders, combined with person-centered advice based on risk profiles can give people knowledge and guidance to manage their own lifestyle priorities.
Aim: To investigate the feasibility of a protocol for a randomized controlled trial (RCT) which will examine the preventive effects of musculoskeletal function examinations and person-centered advice on inactive middle-aged people.
Methods: Physically inactive middle-aged people will be invited to participate in a two-part health examination with follow-up after three months in a pilot study. Part 1 is a standard health examination including blood tests and Part 2 is a functional examination of fitness, strength, mobility, balance and posture according to our protocol based on validated tests. The intervention group receives feedback based on both parts of the examination while the control group receives feedback only from Part 1. Physical activity level will be measured objectively with accelerometers at inclusion and follow-up.
Expected results: The pilot study is expected to show whether the planned RCT is practically feasible and to give relevant support for the power analysis for a later full-scale RCT. Better understanding of personal physical function and risk factors can facilitate lifestyle decisions on the individual level which can reduce the risk for later ill-health and need of health-care. Preventive interventions may contribute to reduce the ever-increasing level of lifestyle-related ill-health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Risk profileStandard health examination and related feedback. Functional examination. Risk profile and related advice. |
| Control group | No intervention | –Standard health examination and related feedback. Functional examination. |
Who may qualify
- Ages
- 39 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Born 1982 (aged 40 years). Self-assessed as physically inactive. Self-reported normal general mobility - can walk without support and has full use of all 4 extremities.
Key exclusion criteria (1 listed)
- Self-reported regular moderate-to-intensive physical activity more than once per week. Pregnancy. Ongoing treatment requiring hospital-based services. Severe mental illness or intellectual impairment. Need of interpreter to participate in the study or answer the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk profileCompiliation of risk profile based on fitness, strength, mobility, balance, posture, physical activity level, weight and pain. Advice based on the above and support in goal-setting. | Behavioural | Intervention group |
Primary outcome
Physical activity level
Time frame: Change between inclusion and 3-4 month follow-up.
Mean number of daily minutes in moderate-to-intensive physical activity measured with accelerometers during one week.
Participant feedback
Time frame: Measured at 3-4 month follow-up.
Rating of overall helpfulness of intervention in intervention group on 0 to 5 numerical rating scale ranging between 0=No help at all and 5=Very helpful.
38 secondary outcomes
Participant feedback functional tests-Borg inclusion
Time frame: Measured at inclusion.
Participant feedback functional tests-Borg follow-up
Time frame: Measured at 3-4 month follow-up.
Participant feedback functional tests-instructions
Time frame: Measured at inclusion.
Participant feedback - descriptive inclusion
Time frame: Recorded at inclusion.
Participant feedback - descriptive follow-up
Time frame: Recorded at 3-4 month follow-up.
Risk levels
Time frame: Change between inclusion and 3-4 month follow-up.
Goal achievement
Time frame: 3-4 month follow-up
Ekblom-Bak fitness test
Time frame: Change between inclusion and 3-4 month follow-up.
2-minute step test
Time frame: Change between inclusion and 3-4 month follow-up.
Body mass index
Time frame: Change between inclusion and 3-4 month follow-up.
Waist circumference
Time frame: Change between inclusion and 3-4 month follow-up.
Handgrip strength
Time frame: Change between inclusion and 3-4 month follow-up.
30-second biceps test
Time frame: Change between inclusion and 3-4 month follow-up.
Unilateral heel rise test
Time frame: Change between inclusion and 3-4 month follow-up.
30-second chair stand test
Time frame: Change between inclusion and 3-4 month follow-up.
Plank test
Time frame: Change between inclusion and 3-4 month follow-up.
Sorenson's back extension test
Time frame: Change between inclusion and 3-4 month follow-up.
Supine bridge test
Time frame: Change between inclusion and 3-4 month follow-up.
Stand-on-one-leg eyes-open test
Time frame: Change between inclusion and 3-4 month follow-up.
Stand-on-one-leg eyes-closed test
Time frame: Change between inclusion and 3-4 month follow-up.
Sharpened Romberg
Time frame: Change between inclusion and 3-4 month follow-up.
Functional Reach test
Time frame: Change between inclusion and 3-4 month follow-up.
Lateral Reach test
Time frame: Change between inclusion and 3-4 month follow-up.
Navicular Drop test
Time frame: Change between inclusion and 3-4 month follow-up.
Occiput-to-wall test
Time frame: Change between inclusion and 3-4 month follow-up.
Patella mobility
Time frame: Change between inclusion and 3-4 month follow-up.
Sit-rise test
Time frame: Change between inclusion and 3-4 month follow-up.
Fingertip-floor test
Time frame: Change between inclusion and 3-4 month follow-up.
Lateral flexion test
Time frame: Change between inclusion and 3-4 month follow-up.
Beighton's hypermobility score
Time frame: Measured at inclusion.
Number of pain locations
Time frame: Change between inclusion and 3-4 month follow-up.
Health-related quality of life
Time frame: Change between inclusion and 3-4 month follow-up.
Self-reported physical activity_SGPALS
Time frame: Change between inclusion and 3-4 month follow-up.
Self-reported physical activity_SNBHW
Time frame: Change between inclusion and 3-4 month follow-up.
Sedentary time
Time frame: Change between inclusion and 3-4 month follow-up.
Risk for developing long-term musculoskeletal disorders
Time frame: Change between inclusion and 3-4 month follow-up.
Blood pressure
Time frame: Change between inclusion and 3-4 month follow-up.
Blood tests
Time frame: Change between inclusion and 3-4 month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Derived from this study: PubMed 39396984Bornhoft L, Arvidsson D, Bergenheim A, Borjesson M, Fridolfsson J, Hellgren M, Nordeman L, Larsson MEH. Function-based risk reduction intervention for lifestyle-related disorders among inactive 40-year-old people: a pilot randomised controlled trial. BMC Public Health. 2024 Oct 13;24(1):2799. doi: 10.1186/s12889-024-20301-6.
- Derived from this study: PubMed 38438859Bornhoft L, Arvidsson D, Bergenheim A, Borjesson M, Fridolfsson J, Hellgren M, Nordeman L, Larsson ME. Development and feasibility of a function-based preventive intervention for lifestyle-related disorders. BMC Public Health. 2024 Mar 4;24(1):681. doi: 10.1186/s12889-024-18017-8.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers than the participating research group.
Related trials for Lifestyle Risk Reduction
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Culinary And Lifestyle Medicine Education for Cancer Risk Reduction in Survivors of Breast Cancer
Breast Cancer
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
RecruitingObservational study
Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation
Breast Neoplasms Diagnosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena Bornhöft, PhD principal investigator
Region Västra Götaland, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk profile in people with Lifestyle Risk Reduction, run by Lena Bornhoft at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: Change between inclusion and 3-4 month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535296, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.