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

NCT05535296 | Completed

• 1 other identifier: VGFOUREG-968488
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Lifestyle Risk Reduction

Keywords

Prevention; Lifesyle-related condition; Physical function; Physical activity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (38)

• Participant feedback functional tests-Borg inclusion

  Measured at inclusion.

• Participant feedback functional tests-Borg follow-up

  Measured at 3-4 month follow-up.

• Participant feedback functional tests-instructions

  Measured at inclusion.

• Participant feedback - descriptive inclusion

  Recorded at inclusion.

• Participant feedback - descriptive follow-up

  Recorded at 3-4 month follow-up.

Study Arms (2)

Intervention group

EXPERIMENTAL

Standard health examination and related feedback. Functional examination. Risk profile and related advice.

Behavioral: Risk profile

Control group

NO INTERVENTION

Standard health examination and related feedback. Functional examination.

Interventions

Risk profile BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 39 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lena Bornhoft: lead
• Vastra Gotaland Region: collaborator
• Region Värmland, Sweden: collaborator

Study Sites (1)

Närhälsan Biskopsgården Health centre

Gothenburg, 418 33, Sweden

Location

Related Publications (2)

• 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.

  PMID: 39396984 DERIVED

• Bornhoft 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.

  PMID: 38438859 DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lena Bornhöft, PhD

  Region Västra Götaland, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist, PhD

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 10, 2022
• Study Start: August 15, 2022
• Primary Completion: March 2, 2023
• Study Completion: April 18, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)