Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04988724
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2021-06-29
Brief Title:
Impact of Physical Exercise at a Hospital
Sponsor:
Nordsjaellands Hospital
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
Impact of Physical Exercise at a Hospital Tested in a Pilot Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aims and Hypotheses Aims
to investigate associations between an intelligent exercise training intervention and clinical health parameters well-being sick leave and productivity at Nordsjællands Hospital NOH
to generate data and experiences to a larger cluster randomized trial with more included departments at NOH
to analyze how the intervention could be successfully implemented in the organization to ensure long-term effects
Outcomes
Aerobic capacity Åstrands ergometer test
Blood pressure and heart rate
Physical activity steps measured by tracker
Self-reported health questionnaire EQ-5D
Self-reported physical activity questionnaire IPAQ
Well-being questions from the Danish Health and Morbidity Survey
Musculoskeletal pain and use of anti-pain medications Numeric Rating Scale
Monetized value of productivity loss
Productivity using an employers perspective scale 1-10
Sick leave days in short term 14 days and long term 14 days data will be delivered by The Department of HR
Muscle strength in knee extension dynamometer
Intervention The concept of intelligent training at the worksite is an individualized exercise training where the exercises are 1 balanced to the physiological capacity of the employees relative to their occupational exposure 2 tailored to the individual capacities and disorders to improve employees health 3 motivating by offering evidence based and enjoyable programs implemented with care and 4 cost-effective for the company
The intervention period is 20 weeks of intelligent exercise training Every week several exercise sessions will be offered to the participants in the intervention group during the working hours The exercise sessions will be of 30 min durations twice a week and include aerobic exercise with high intensity 16 on the Borg scale rate of perceived exhaustion resistance training andor functional training In addition there will be a number of intelligent exercise sessions of 30 min durations before and after the most common working hours with a primary focus on aerobic exercise The exercise sessions will be supervised by exercise experts education in sport or physiotherapy
The intelligent exercise interventions will be adjusted to the individual participants physical capacity and limitations thus as one participant may perform aerobic exercise another person may perform resistance training
to investigate associations between an intelligent exercise training intervention and clinical health parameters well-being sick leave and productivity at Nordsjællands Hospital NOH
to generate data and experiences to a larger cluster randomized trial with more included departments at NOH
to analyze how the intervention could be successfully implemented in the organization to ensure long-term effects
Outcomes
Aerobic capacity Åstrands ergometer test
Blood pressure and heart rate
Physical activity steps measured by tracker
Self-reported health questionnaire EQ-5D
Self-reported physical activity questionnaire IPAQ
Well-being questions from the Danish Health and Morbidity Survey
Musculoskeletal pain and use of anti-pain medications Numeric Rating Scale
Monetized value of productivity loss
Productivity using an employers perspective scale 1-10
Sick leave days in short term 14 days and long term 14 days data will be delivered by The Department of HR
Muscle strength in knee extension dynamometer
Intervention The concept of intelligent training at the worksite is an individualized exercise training where the exercises are 1 balanced to the physiological capacity of the employees relative to their occupational exposure 2 tailored to the individual capacities and disorders to improve employees health 3 motivating by offering evidence based and enjoyable programs implemented with care and 4 cost-effective for the company
The intervention period is 20 weeks of intelligent exercise training Every week several exercise sessions will be offered to the participants in the intervention group during the working hours The exercise sessions will be of 30 min durations twice a week and include aerobic exercise with high intensity 16 on the Borg scale rate of perceived exhaustion resistance training andor functional training In addition there will be a number of intelligent exercise sessions of 30 min durations before and after the most common working hours with a primary focus on aerobic exercise The exercise sessions will be supervised by exercise experts education in sport or physiotherapy
The intelligent exercise interventions will be adjusted to the individual participants physical capacity and limitations thus as one participant may perform aerobic exercise another person may perform resistance training
Detailed Description:
In this pilot study we will investigate the potential of physical training at departments at NOH A large university hospital covering a population of 17 mio citizens in the Northern Region of Zealand and one of eight new Danish super-hospitals We will invite all health care workers from the participating departments at the hospital to be enrolled in the study and apply the intelligent exercise intervention where each participant will receive a tailored intervention exercise plan based on an individual assessment including the mapping of the participants needs and motivation 2
References can be found at the end of the document
Participants The 15 departments will be invited and it is anticipated that 700 employed will volunteer to the study
All employees nurses doctors secretaries and other staff in the departments will be invited to the study The recruitment will follow a strategy with local information at the departments regarding the study intervention and tests
Intervention The concept of intelligent training at the worksite is an individualized exercise training where the exercises are 1 balanced to the physiological capacity of the employees relative to their occupational exposure 2 tailored to the individual capacities and disorders to improve employees health 3 motivating by offering evidence based and enjoyable programs implemented with care and 4 cost-effective for the company
The intervention period is three months of intelligent exercise training Every week several exercise sessions will be offered to the participants in the intervention group during the working hours The exercise sessions will be of 30 min durations twice a week and include aerobic exercise with high intensity 16 on the Borg scale rate of perceived exhaustion resistance training andor functional training 12 In addition there will be a number of intelligent exercise sessions of 30 min durations before and after the most common working hours with a primary focus on aerobic exercise The exercise sessions will be supervised by exercise experts education in sport or physiotherapy
The intelligent exercise interventions will be adjusted to the individual participants physical capacity and limitations thus as one participant may perform aerobic exercise another person may perform resistance training 12
A goal will be that as many as possible will participate in minimum 60 min intelligent exercise training per week
Prior to the intervention the participants will also be offered motivational support by a special educated staff to increase the level of leisure time physical activity and the level of general physical activity at work
There will be offered intelligent exercise interventions to those on evening duties
During the intervention periods the participants will be supported by trained exercise ambassadors
Sample size calculation The study will be performed without a sample size calculation as it is a pilot trial to generate data before the intervention is tested in a larger cluster randomized trial with sufficient power to assess the validity of the results
Statistical analyses The analyses of the changes of the numeric outcome variables during the study will be assessed using Students t test if data are normally distributed or Wilcoxon Signed Ranks Test if data are not normally distributed Changes of categorical variables will be analysed using a Chi2 test
The associations between groups of staff nurses medical doctors and other and changes of outcome variables physical activity productivity sick leave physical capacity will be tested in multiple linear regression models with confounder adjustments
Results are considered significant 2-tailed when p005 The statistical analyses will be performed in collaboration with a statistician from Section of Biostatistics Department of Public Health University of Copenhagen
Subjects Every employee eg nurses doctors secretaries lab technician from the departments at NOH will be invited to the study but only those who agree in writing will be included
Short-term and long-term risks side effects and disadvantages Participants who have not previously been physically active may experience transient side effects such as sore muscles shortness of breath etc There are no immediate risks associated with the intervention as it is adapted to the physical ability of the individual subject The therapeutic benefit for participants and future employees justifies an intervention like this
Biological material None
Processing of personal data in the project The study will be approved by the Danish Data Protection Agency The collected data will be stored in RedCap according to rules of the data protection agency in the Capital Region All project data collected will be handled in accordance with the rules of the Capital Region in relation to current legislation No data are sent abroad
Funding The initiative to plan and execute the study is done by senior researcher associate professor Stig Mølsted and other researchers employed at NOH The study is supported by NOH with a grant of 50000 DKK to the initial analysis In addition NOH supports the study with other payments including the costs related to the participants exercise training during the working hours To ensure the realizability of this study several funding application initiatives are in the pipeline for 2021-3 and forth including Danish national and private funds
Grants will be deposited into a hospital account Members of the study group will have no financial affiliation with donors
Remuneration No remuneration is paid to the project participants
Recruitment of subjects and informed consent Potential study participants in the included departments will receive written information about the project explaining the intervention Oral information will be provided at joint meetings at the hospital to which test subjects are invited Interested participants will also receive a written consent form Prior to obtaining the informed consent it will be ensured that the participants will have time and opportunity to read the information ask questions and consider whether to participate If the participant wishes to be included in the study the consent declaration is dated and signed by the study participant and by the health care professional who provided the information
Presentation of the results The results should have special interest to hospitals in Denmark and worldwide The results of the study will also be of interest in other public and private companies
The study results will be presented at national and international meetings and congresses in international peer reviewed journals and in public media Both positive negative and inconclusive results will be published The study will be registered at wwwclinicaltrialsgov
Ethics In this scientific experiment all participants receive a training program tailored to the individual Each individual participant is being physically pressured to an extent that one must not assume will be of any long-term burden to the participant If any test results call for further investigations of a participant the participant will be encouraged to consult the persons general practitioner
Adverse effects related to the exercise interventions will be registered and evaluated in the study The therapeutic benefit for participants and future employees justifies an intervention like this as this intervention is expected to raise public health in general
Adverse effects related to the exercise interventions will be registered and evaluated in the study
References
1 Pedersen BK Saltin B Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases Scand J Med Sci Sports 2015 Dec25 Suppl 31-72
2 Justesen JB Sogaard K Dalager T Christensen JR Sjogaard G The Effect of Intelligent Physical Exercise Training on Sickness Presenteeism and Absenteeism Among Office Workers J Occup Environ Med 2017 Oct5910942-948
3 Jakobsen MD Sundstrup E Brandt M Andersen LL Psychosocial benefits of workplace physical exercise cluster randomized controlled trial BMC Public Health 2017 Oct 10171798-017-4728-3
4 Korshoj M Birk Jorgensen M Lidegaard M Mortensen OS Krustrup P Holtermann A et al Decrease in musculoskeletal pain after 4 and 12 months of an aerobic exercise intervention a worksite RCT among cleaners Scand J Public Health 2018 Dec468846-853
5 Blangsted AK Sogaard K Hansen EA Hannerz H Sjogaard G One-year randomized controlled trial with different physical-activity programs to reduce musculoskeletal symptoms in the neck and shoulders among office workers Scand J Work Environ Health 2008 Feb34155-65
6 Jakobsen MD Sundstrup E Brandt M Jay K Aagaard P Andersen LL Effect of workplace- versus home-based physical exercise on musculoskeletal pain among health care workers a cluster randomized controlled trial Scand J Work Environ Health 2015 Mar412153-163
7 van den Berg S Burdorf A Robroek SJW Associations between common diseases and work ability and sick leave among health care workers Int Arch Occup Environ Health 2017 Oct907685-693
8 European Foundation for the Improvement of Living and Working Conditions httpwwweurofoundeuropaeu Absence from work European Foundation for the Improvement of Living and Working Conditions 2010
9 Korshoj M Lidegaard M Skotte JH Krustrup P Krause N Sogaard K et al Does aerobic exercise improve or impair cardiorespiratory fitness and health among cleaners A cluster randomized controlled trial Scand J Work Environ Health 2015 Mar412140-152
10 Lidegaard M Sogaard K Krustrup P Holtermann A Korshoj M Effects of 12 months aerobic exercise intervention on work ability need for recovery productivity and rating of exertion among cleaners a worksite RCT Int Arch Occup Environ Health 2018 Feb912225-235
11 Andersen LL Kjaer M Sogaard K Hansen L Kryger AI Sjogaard G Effect of two contrasting types of physical exercise on chronic neck muscle pain Arthritis Rheum 2008 Jan 1559184-91
12 Sjogaard G Justesen JB Murray M Dalager T Sogaard K A conceptual model for worksite intelligent physical exercise training--IPET--intervention for decreasing life style health risk indicators among employees a randomized controlled trial BMC Public Health 2014 Jun 2614652-2458-14-652
13 Danish Health and Medicines Authority Specialeplanlægning 2015 April978-87-7104-601-411
14 Danmarks Radio Danmarkskort Her er der størst lægemangel 2018 Available at httpswwwdrdknyhederindlanddanmarkskort-her-er-der-stoerst-laegemangel Accessed 0829 2019
15 Kristensen MT Sundhedsreform kan forværre manglen på prkatiserende læger hvor den er størst 201910
16 Danmarks Radio Lægemangel i uskantsområderne er tredoblet under Lars Løkke 2019 Available at httpswwwdrdknyhederpolitiklaegemangel-i-udkantsomraaderne-er-tredoblet-under-lars-loekke Accessed 0829 2019
17 Pronk NP Martinson B Kessler RC Beck AL Simon GE Wang P The association between work performance and physical activity cardiorespiratory fitness and obesity J Occup Environ Med 2004 Jan46119-25
18 Pereira M Comans T Sjogaard G Straker L Melloh M OLeary S et al The impact of workplace ergonomics and neck-specific exercise versus ergonomics and health promotion interventions on office worker productivity A cluster-randomized trial Scand J Work Environ Health 2019 Jan 145142-52
19 Jensen TM Eriksen SBM Larsen JS Aadahl M Rasmussen SS Olesen LB et al Exercise training is associated with reduced pains from the musculoskeletal system in patients with type 2 diabetes Diabetes Res Clin Pract 2019 154124-129
References can be found at the end of the document
Participants The 15 departments will be invited and it is anticipated that 700 employed will volunteer to the study
All employees nurses doctors secretaries and other staff in the departments will be invited to the study The recruitment will follow a strategy with local information at the departments regarding the study intervention and tests
Intervention The concept of intelligent training at the worksite is an individualized exercise training where the exercises are 1 balanced to the physiological capacity of the employees relative to their occupational exposure 2 tailored to the individual capacities and disorders to improve employees health 3 motivating by offering evidence based and enjoyable programs implemented with care and 4 cost-effective for the company
The intervention period is three months of intelligent exercise training Every week several exercise sessions will be offered to the participants in the intervention group during the working hours The exercise sessions will be of 30 min durations twice a week and include aerobic exercise with high intensity 16 on the Borg scale rate of perceived exhaustion resistance training andor functional training 12 In addition there will be a number of intelligent exercise sessions of 30 min durations before and after the most common working hours with a primary focus on aerobic exercise The exercise sessions will be supervised by exercise experts education in sport or physiotherapy
The intelligent exercise interventions will be adjusted to the individual participants physical capacity and limitations thus as one participant may perform aerobic exercise another person may perform resistance training 12
A goal will be that as many as possible will participate in minimum 60 min intelligent exercise training per week
Prior to the intervention the participants will also be offered motivational support by a special educated staff to increase the level of leisure time physical activity and the level of general physical activity at work
There will be offered intelligent exercise interventions to those on evening duties
During the intervention periods the participants will be supported by trained exercise ambassadors
Sample size calculation The study will be performed without a sample size calculation as it is a pilot trial to generate data before the intervention is tested in a larger cluster randomized trial with sufficient power to assess the validity of the results
Statistical analyses The analyses of the changes of the numeric outcome variables during the study will be assessed using Students t test if data are normally distributed or Wilcoxon Signed Ranks Test if data are not normally distributed Changes of categorical variables will be analysed using a Chi2 test
The associations between groups of staff nurses medical doctors and other and changes of outcome variables physical activity productivity sick leave physical capacity will be tested in multiple linear regression models with confounder adjustments
Results are considered significant 2-tailed when p005 The statistical analyses will be performed in collaboration with a statistician from Section of Biostatistics Department of Public Health University of Copenhagen
Subjects Every employee eg nurses doctors secretaries lab technician from the departments at NOH will be invited to the study but only those who agree in writing will be included
Short-term and long-term risks side effects and disadvantages Participants who have not previously been physically active may experience transient side effects such as sore muscles shortness of breath etc There are no immediate risks associated with the intervention as it is adapted to the physical ability of the individual subject The therapeutic benefit for participants and future employees justifies an intervention like this
Biological material None
Processing of personal data in the project The study will be approved by the Danish Data Protection Agency The collected data will be stored in RedCap according to rules of the data protection agency in the Capital Region All project data collected will be handled in accordance with the rules of the Capital Region in relation to current legislation No data are sent abroad
Funding The initiative to plan and execute the study is done by senior researcher associate professor Stig Mølsted and other researchers employed at NOH The study is supported by NOH with a grant of 50000 DKK to the initial analysis In addition NOH supports the study with other payments including the costs related to the participants exercise training during the working hours To ensure the realizability of this study several funding application initiatives are in the pipeline for 2021-3 and forth including Danish national and private funds
Grants will be deposited into a hospital account Members of the study group will have no financial affiliation with donors
Remuneration No remuneration is paid to the project participants
Recruitment of subjects and informed consent Potential study participants in the included departments will receive written information about the project explaining the intervention Oral information will be provided at joint meetings at the hospital to which test subjects are invited Interested participants will also receive a written consent form Prior to obtaining the informed consent it will be ensured that the participants will have time and opportunity to read the information ask questions and consider whether to participate If the participant wishes to be included in the study the consent declaration is dated and signed by the study participant and by the health care professional who provided the information
Presentation of the results The results should have special interest to hospitals in Denmark and worldwide The results of the study will also be of interest in other public and private companies
The study results will be presented at national and international meetings and congresses in international peer reviewed journals and in public media Both positive negative and inconclusive results will be published The study will be registered at wwwclinicaltrialsgov
Ethics In this scientific experiment all participants receive a training program tailored to the individual Each individual participant is being physically pressured to an extent that one must not assume will be of any long-term burden to the participant If any test results call for further investigations of a participant the participant will be encouraged to consult the persons general practitioner
Adverse effects related to the exercise interventions will be registered and evaluated in the study The therapeutic benefit for participants and future employees justifies an intervention like this as this intervention is expected to raise public health in general
Adverse effects related to the exercise interventions will be registered and evaluated in the study
References
1 Pedersen BK Saltin B Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases Scand J Med Sci Sports 2015 Dec25 Suppl 31-72
2 Justesen JB Sogaard K Dalager T Christensen JR Sjogaard G The Effect of Intelligent Physical Exercise Training on Sickness Presenteeism and Absenteeism Among Office Workers J Occup Environ Med 2017 Oct5910942-948
3 Jakobsen MD Sundstrup E Brandt M Andersen LL Psychosocial benefits of workplace physical exercise cluster randomized controlled trial BMC Public Health 2017 Oct 10171798-017-4728-3
4 Korshoj M Birk Jorgensen M Lidegaard M Mortensen OS Krustrup P Holtermann A et al Decrease in musculoskeletal pain after 4 and 12 months of an aerobic exercise intervention a worksite RCT among cleaners Scand J Public Health 2018 Dec468846-853
5 Blangsted AK Sogaard K Hansen EA Hannerz H Sjogaard G One-year randomized controlled trial with different physical-activity programs to reduce musculoskeletal symptoms in the neck and shoulders among office workers Scand J Work Environ Health 2008 Feb34155-65
6 Jakobsen MD Sundstrup E Brandt M Jay K Aagaard P Andersen LL Effect of workplace- versus home-based physical exercise on musculoskeletal pain among health care workers a cluster randomized controlled trial Scand J Work Environ Health 2015 Mar412153-163
7 van den Berg S Burdorf A Robroek SJW Associations between common diseases and work ability and sick leave among health care workers Int Arch Occup Environ Health 2017 Oct907685-693
8 European Foundation for the Improvement of Living and Working Conditions httpwwweurofoundeuropaeu Absence from work European Foundation for the Improvement of Living and Working Conditions 2010
9 Korshoj M Lidegaard M Skotte JH Krustrup P Krause N Sogaard K et al Does aerobic exercise improve or impair cardiorespiratory fitness and health among cleaners A cluster randomized controlled trial Scand J Work Environ Health 2015 Mar412140-152
10 Lidegaard M Sogaard K Krustrup P Holtermann A Korshoj M Effects of 12 months aerobic exercise intervention on work ability need for recovery productivity and rating of exertion among cleaners a worksite RCT Int Arch Occup Environ Health 2018 Feb912225-235
11 Andersen LL Kjaer M Sogaard K Hansen L Kryger AI Sjogaard G Effect of two contrasting types of physical exercise on chronic neck muscle pain Arthritis Rheum 2008 Jan 1559184-91
12 Sjogaard G Justesen JB Murray M Dalager T Sogaard K A conceptual model for worksite intelligent physical exercise training--IPET--intervention for decreasing life style health risk indicators among employees a randomized controlled trial BMC Public Health 2014 Jun 2614652-2458-14-652
13 Danish Health and Medicines Authority Specialeplanlægning 2015 April978-87-7104-601-411
14 Danmarks Radio Danmarkskort Her er der størst lægemangel 2018 Available at httpswwwdrdknyhederindlanddanmarkskort-her-er-der-stoerst-laegemangel Accessed 0829 2019
15 Kristensen MT Sundhedsreform kan forværre manglen på prkatiserende læger hvor den er størst 201910
16 Danmarks Radio Lægemangel i uskantsområderne er tredoblet under Lars Løkke 2019 Available at httpswwwdrdknyhederpolitiklaegemangel-i-udkantsomraaderne-er-tredoblet-under-lars-loekke Accessed 0829 2019
17 Pronk NP Martinson B Kessler RC Beck AL Simon GE Wang P The association between work performance and physical activity cardiorespiratory fitness and obesity J Occup Environ Med 2004 Jan46119-25
18 Pereira M Comans T Sjogaard G Straker L Melloh M OLeary S et al The impact of workplace ergonomics and neck-specific exercise versus ergonomics and health promotion interventions on office worker productivity A cluster-randomized trial Scand J Work Environ Health 2019 Jan 145142-52
19 Jensen TM Eriksen SBM Larsen JS Aadahl M Rasmussen SS Olesen LB et al Exercise training is associated with reduced pains from the musculoskeletal system in patients with type 2 diabetes Diabetes Res Clin Pract 2019 154124-129
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None