Personalized Exercise Counseling to Promote Workability

NCT03854201 | Unknown

• 2 other identifiers: UKK Institute_Nokia CityETL code R18184
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

The study design is a 2-arm randomized controlled trial with 6-month intervention period and follow-up at 6, 12 and 24 months among blue-color workers of Nokia City with reduced work ability and high number of musculoskeletal problems. The participants (n=190) will be randomly assigned to intervention-arm providing face-to-face Personalized Exercise Counseling combined with interactive accelerometer (PEC-arm) or a non-intervention Control-arm. The study aims at improving workability (main outcome) and reducing musculoskeletal pain by counseling and motivating the workers to increase physical activity and exercise according to self-selected modes. Exercise instructors of Nokia City are responsible for providing the face-to-face part of PEC. The Urho Kaleva Kekkonen (UKK) Institute is responsible for providing online feedback of the data collected by the interactive ExSed® accelerometer, stored and analyzed in the Cloud, from where the participants in the PEC-arm receive daily feedback thru a smart phone application. Cost-effectiveness of the PEC-intervention compared to the Control-arm in terms of quality adjusted life-years (QALY) and days of sickness absence are also investigated. The following measurements will be taken at baseline and the three follow-up timepoints: work-, health- and physical activity related factors collected by two electronic questionnaires, objective measurements of movement continuum (sleep, sedentary behavior, standing-ups, standing, light activity, moderate activity, vigorous activity) for 24/7 (RM42 research accelerometer), 3 tests of physical fitness and blood samples related to blood sugar and lipid profile.

Conditions

Physical Functioning; Musculoskeletal Pain; Quality of Life; Physical Activity

Keywords

workability, sickness absence, health promotion, costs

Outcome Measures

Primary Outcomes (1)

• Change in Work ability score (WAS) at follow-up time points

  Current work ability compared with lifetime best rated on a scale from 0 (completely unable to work) to 10 (work ability at its best).

  Baseline, 6, 12 and 24 months

Secondary Outcomes (3)

• Intensity of musculoskeletal pain measured with Visual Analog Scale (VAS) in different anatomical sites: neck-shoulder, lower back, upper extremities, lower extremities

  Baseline, 6, 12 and 24 months

• Objectively measured physical activity continuum (24/7) for 7 days

  Baseline, 6, 12 and 24 months

• Cost effectiveness: Quality Adjusted Life Years (QALY)

  Baseline, 6, 12 and 24 months

Study Arms (2)

Personalized Exercise Counseling (PEC)

EXPERIMENTAL

The Personalized Exercise Counselling intervention includes 3 face-face counseling sessions and 4-6 phone calls during six months. In addition, the participants are provided with the ExSed® interactive accelerometer to record their physical activity 24/7 from which they will receive personal daily feedback on their smart phone, which is provided to each person not having a suitable one of their own to be used during the 6-month intervention period.

Behavioral: Personalized Exercise Counseling (PEC)

Control-arm

NO INTERVENTION

The participants only take part in the study measurements at baseline and the three follow-up time points. They will be provided personal written information by the UKK Institute on their blood sugar and lipid profiles, objectively measured physical activity (light, moderate, vigorous), standing, sedentary behaviour and sleep, and the three fitness tests measuring flexibility, muscular strength and cardiorespiratory fitness.

Interventions

Personalized Exercise Counseling (PEC) BEHAVIORAL

At the first counseling appointment, PEC-participants answer the physical activity (PA) questionnaire, perform fitness tests and discuss with their exercise instructor. The target is a personalized short-term PA plan including where and when the PA/exercise takes place and what is the mode. Participants may choose instructed group-exercise sessions provided by the municipal sports/leisure sector or exercising alone as preferred. The exercise instructors utilize the fitness test results and feedback data of the research accelerometers by the UKK Institute to guide the participants. The PEC includes 2 more face-to-face sessions and 4-6 phone calls by the instructors aimed at checking the realization of exercise plans and discussing the outcomes provided by the interactive accelerometer.

Personalized Exercise Counseling (PEC)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Reduced workability of less than 8 in the numeric rating scale assessed by the Work Ability Scale (WAS), an item of the Work Ability Index (WAI), as "Current work ability compared with lifetime best rated on a numeric rating scale from 0 (completely unable to work) to 10 (work ability at its best)"

You may not qualify if:

• not likely to be albe to do one's current job two years from now assessed with Future Walk Ability (FWA) item from WAI "Do you believe that, from your health perspective, you will be able to do your current job two years from now?"' was rated with three response alternatives: unlikely (1), not certain (2) and relatively certain (3)

Sponsors & Collaborators

• UKK Institute: lead
• City of Nokia: collaborator

Study Sites (1)

UKK Insitute for Health Promotion Research

Tampere, 33500, Finland

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Tuomas Erkkilä, Dr.

  Human Reserach Manager, City of Nokia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: After the screening phase, all electronic questionnaire data will be collected in the form of pseudonymity i.e. using only the numeric identification codes. All data (results of blood samples, fitness tests, research accelerometers) will be saved and analysed using only the codes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reserach and Development Manager

Model Details: Randomized Controlled Trial with two-arm study design: 1. Intervention-arm: Face-to-face Personalized Exercise Counseling combined with interactive ExSed® accelerometer (PEC) 2. Non-treament-arm: Participation in the study measurement only, and written information with individual feedback on blood sugar and lipid profile, fitness test results and objectively measured physical activity 24/7 after each of the four measurement points (Control-arm)

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 26, 2019
• Study Start: December 10, 2018
• Primary Completion: December 10, 2021
• Study Completion: December 20, 2023
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)