Physical FunctioningPEC-NokiaNCT03854201
Personalized Exercise Counseling to Promote Workability
A study testing Personalized Exercise Counseling (PEC) in people with Physical Functioning and Musculoskeletal Pain, run by UKK Institute at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Functioning, Musculoskeletal Pain, Quality of Life
- What is being tested?
- Personalized Exercise Counseling (PEC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteFinland
- Study dates
- 10 Dec 2018to 20 Dec 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 Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)"
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Exercise Counseling to Promote Workability and Health of Municipal Workers With Musculoskeletal Pain in Nokia City, Finland
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.
Read the detailed 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.
- Being tested
- Personalized Exercise Counseling (PEC)
- Keywords
- workability, sickness absence, health promotion, costs
- Medical subject headings
- Musculoskeletal Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Exercise Counseling (PEC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
100-mm visual analog scale, 40mm indicating clinically meaningful level of pain
Measured: Baseline, 6, 12 and 24 months
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
Measured: Baseline, 6, 12 and 24 months
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.
Measured: Baseline, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start10 Dec 2018
- Primary completion10 Dec 2021 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FunctioningStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UKK Institute
- Sponsor type
- University, hospital or other
- Collaborators
- City of Nokia
- Responsible party
- Principal investigator, Jaana Suni, UKK Institute
- Investigators
- Tuomas Erkkilä, Dr., Study chair, Human Reserach Manager, City of Nokia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854201
- Sponsor's protocol ID
- UKK Institute_Nokia City
- Other IDs
- ETL code R18184
- Acronym
- PEC-Nokia
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Exercise Counseling to Promote Workability and Health of Municipal Workers With Musculoskeletal Pain in Nokia City, Finland
- ClinicalTrials.gov ID
- NCT03854201
- Acronym / sponsor ID
- PEC-Nokia / UKK Institute_Nokia City
- Keywords
- workability, sickness absence, health promotion, costs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- UKK InstituteUniversity, hospital or other
- Collaborators
- City of Nokia
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 10 Dec 2021 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 26 Feb 2019 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Personalized Exercise Counseling (PEC) | Experimental | Behavioral: Personalized Exercise Counseling (PEC)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. |
| 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. |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)"
Key exclusion criteria (1 listed)
- 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)
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 |
|---|---|---|
| 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. | Behavioural | Personalized Exercise Counseling (PEC) |
Primary outcome
Change in Work ability score (WAS) at follow-up time points
Time frame: Baseline, 6, 12 and 24 months
Current work ability compared with lifetime best rated on a scale from 0 (completely unable to work) to 10 (work ability at its best).
3 secondary outcomes
Intensity of musculoskeletal pain measured with Visual Analog Scale (VAS) in different anatomical sites: neck-shoulder, lower back, upper extremities, lower extremities
Time frame: Baseline, 6, 12 and 24 months
Objectively measured physical activity continuum (24/7) for 7 days
Time frame: Baseline, 6, 12 and 24 months
Cost effectiveness: Quality Adjusted Life Years (QALY)
Time frame: Baseline, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Tuomas Erkkilä, Dr. study chair
Human Reserach Manager, City of Nokia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Exercise Counseling (PEC) in people with Physical Functioning and Musculoskeletal Pain, run by UKK Institute at 1 site in Finland.
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: status not confirmed, as of the sponsor's last update on 26 Feb 2019. 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 Finland. 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?
Results are not available in the source record.
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?
Change in Work ability score (WAS) at follow-up time points (time frame: Baseline, 6, 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2019.