Personalized Exercise Counseling to Promote Workability

Quality of Life Clinical Trial

— PEC-Nokia  

Official title:

Personalized Exercise Counseling to Promote Workability and Health of Municipal Workers With Musculoskeletal Pain in Nokia City, Finland

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03854201
• Other study ID #: UKK Institute_Nokia City
• Secondary ID: ETL code R18184
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: December 20, 2023

Study information

• Verified date: February 2019
• Source: UKK Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Sick-leaves due to musculoskeletal disorders (MSDs) among municipal workers of Nokia City increased notably during the year 2017, which was noticed as increased call and burden in occupation healthcare settings. According to the disease grading statistics of early retirement, MSDs were the leading cause. Due to the afore facts Nokia City composed a novel model of co-operation between the personnel administration and exercise facilities of Nokia City: The coordinator of wellbeing (occupational nurse) now prescribes exercise referrals for patients to directly contact the sports sector for personalized exercise counseling.

The purpose of the present study is to investigate the effectiveness and cost-effectiveness of the afore described novel operations model of exercise referral in the Nokia City. Personalized Exercise Counseling (PEC) intervention guides and motivates the workers to set and achieve personal exercise/physical activity goals. The hypothesis is that the PEC improves workability (main outcome) and reduces musculoskeletal pain, and thus improves quality of life and reduces days of sickness absence. Regarding cost-effectiveness of the PEC-arm is expected to be cost-effective in terms of quality adjusted life-years (QALY) and days of sickness absence compared to the Control-arm.

The target population of the PEC-Nokia study is practical nurses, personnel of kitchen and cleaning service and janitorial service. In case that the number of participants fulfilling the inclusion criteria of these occupational groups is not adequate to reach the number needed to be randomized (n=190), other occupations may be recruited.

Sample size was calculated based on the work ability score (WAS) i.e. current work ability compared to lifetime best on numeric rating scale from 0 (completely unable to work) to 10 (work ability at its best). Thus, to detect a difference in main effects (i.e., Personalized Exercise Counselling (PEC) group vs. non-treatment group (Control) with a significance level of 0.05 and a power of 90%, the study required at least 150 participants (75 in each study-arm). For compensation of probable loss of participants to follow-up, the aim is to recruit 190 participants. We expect that there would be a minimal difference of 15% between the PEC-arm and Control-arm among those with improved WAS-score to the good level (i.e. at least 8). We expect that 5% of the participants in the Control-arm and 20% in the PEC-arm will reach the afore target. Reductions of 30% or 15mm (0-100) in intensity of musculoskeletal pain levels at neck-shoulder, lower back, and knee would meet the criteria of clinically important change.

The participants (n=190) will be randomly assigned into 6-month Personalized Exercise Counseling combined with interactive accelerometer (PEC-arm) or a non-intervention Control-arm. Statistician KT will randomly assign about 200 persons to one of the two parallel groups in a 1:1 ratio using a computer-generated procedure. The codes of the study group will be provided to the participants fulfilling the inclusion criteria, using the method of sealed envelopes, immediately after the person has given his/her written consent to participate to the well-being coordinator (specialist nurse of occupational health employed by Nokia City). Only the investigators (i.e. the research group) will be blinded to group allocation.

Electronic questionnaires have been prepared to cover the following: Work-related factors include perceived physical strain, perceived exertion after typical work day at different body sites of musculoskeletal structures and work stress; Health-related factors include perceived health, depression, sleep and recovery, quality of life and days of sickness absence; Physical activity related factors include preferred activity modes and motivation, Fear Avoidance Beliefs related to physical activity at work and leisure-time. In addition, the following physical tests will be used to measure health-related fitness: Neck-shoulder mobility for flexibility, Modified push-ups for upper body strength and trunk stability and 6 minutes' walk test for cardiorespiratory fitness in terms of distance walked and predicted maximal oxygen uptake.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 190
• Est. completion date: December 20, 2023
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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)"

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Personalized Exercise Counseling (PEC)
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.

Locations

Country	Name	City	State
Finland	UKK Insitute for Health Promotion Research	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
UKK Institute	City of Nokia

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intensity of musculoskeletal pain measured with Visual Analog Scale (VAS) in different anatomical sites: neck-shoulder, lower back, upper extremities, lower extremities	100-mm visual analog scale, 40mm indicating clinically meaningful level of pain	Baseline, 6, 12 and 24 months
Secondary	Objectively measured physical activity continuum (24/7) for 7 days	During waking hours the small size three axial research accelerometer RM42 is worn on the right waist in an elastic belt; during sleeping hours in a wrist	Baseline, 6, 12 and 24 months
Secondary	Cost effectiveness: Quality Adjusted Life Years (QALY)	Cost-effectiveness is expressed as incremental cost-effectiveness ratios (ICERs), calculated as the ratio of the difference in mean total costs (including healthcare costs, medication, costs of sickness absence, and intervention costs) and main effects (i.e., change in QALY) at the level of the study-arms.; QALY were calculated from the SF-6D score derived from the original SF-36 data, which is a validated instrument for measuring the physical and mental components of quality of life.	Baseline, 6, 12 and 24 months