Prevention of Lifestyle-related Ill-health With Early Functional Examinations and Individualized Risk Profiles (PREVFUNKTION)

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.

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 Overview

• Status: Completed
• Conditions: Lifestyle Risk Reduction
• Intervention / Treatment: Behavioral: Risk profile

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 418 33
    • Närhälsan Biskopsgården Health centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 39 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Standard health examination and related feedback. Functional examination. Risk profile and related advice.	Behavioral: Risk profile; 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.
No Intervention: Control group; Standard health examination and related feedback. Functional examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level	Mean number of daily minutes in moderate-to-intensive physical activity measured with accelerometers during one week.	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 at 3-4 month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 at inclusion.
Participant feedback - descriptive inclusion	Voluntary subjective impressions of the intervention	Recorded at inclusion.
Participant feedback - descriptive follow-up	Voluntary subjective impressions of the intervention	Recorded at 3-4 month follow-up.
Risk levels	Change in risk levels on the risk profile.	Change between inclusion and 3-4 month follow-up.
Goal achievement	Proportion of goals set at inclusion achieved.	3-4 month follow-up
Ekblom-Bak fitness test	Measured as VO2-max in ml/kg/min where higher values indicate better fitness level.	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.	Change between inclusion and 3-4 month follow-up.
Body mass index	Calculated by weight in kg divided by squared height in meters.	Change between inclusion and 3-4 month follow-up.
Waist circumference	Measured in centimeters with measuring tape.	Change between inclusion and 3-4 month follow-up.
Handgrip strength	Measured with Jamar dynamometer, with higher numbers indicating greater strength.	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.	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.	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.	Change between inclusion and 3-4 month follow-up.
Plank test	Measured with maximum endurance time, with longer time indicating better trunk strength.	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.	Change between inclusion and 3-4 month follow-up.
Supine bridge test	Measured with maximum endurance time, with longer time indicating better trunk strength.	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.	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.	Change between inclusion and 3-4 month follow-up.
Sharpened Romberg	Measured with maximum endurance time, with higher numbers indicating better balance.	Change between inclusion and 3-4 month follow-up.
Functional Reach test	Measured with reach limit in centimeters, with higher numbers indicating better balance.	Change between inclusion and 3-4 month follow-up.
Lateral Reach test	Measured with reach limit in centimeters, with higher numbers indicating better balance.	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.	Change between inclusion and 3-4 month follow-up.
Occiput-to-wall test	Measured as contact or no contact between head and wall.	Change between inclusion and 3-4 month follow-up.
Patella mobility	Measured as locked or not locked patella in habitual standing position.	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.	Change between inclusion and 3-4 month follow-up.
Fingertip-floor test	Measured as distance in centimeters, with higher numbers indicating lower mobility.	Change between inclusion and 3-4 month follow-up.
Lateral flexion test	Measured as distance in millimeters, with higher numbers indicating better mobility.	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 at inclusion.
Number of pain locations	Change in number of pain locations on pain diagram.	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.	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.	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.	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.	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.	Change between inclusion and 3-4 month follow-up.
Blood pressure	Change in blood pressure.	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).	Change between inclusion and 3-4 month follow-up.

Collaborators and Investigators

• Sponsor: Lena Bornhoft
• Collaborators: Region Västra Götaland, Sweden; Region Värmland, Sweden
• Investigators: Principal Investigator: Lena Bornhöft, PhD, Region Västra Götaland, University of Gothenburg

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): March 2, 2023
• Study Completion (Actual): April 18, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Physical activity; Prevention; Physical function; Lifesyle-related condition
• Other Study ID Numbers: VGFOUREG-968488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD with other researchers than the participating research group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No