Exercise Training
BehavioralExercise training with aerobic and strength training, 30 min per session
NCT Number: NCT04988724
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 (Åstrand's 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 employer´s 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 and/or 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 participant's physical capacity and limitations; thus, as one participant may perform aerobic exercise, another person may perform resistance training.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Nordsjællands Hospital, Hillerød, Capital Region, Denmark
In this pilot study, we will investigate the potential of physical training at departments at NOH. A large university hospital covering a population of 1,7 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 participant's 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 and/or 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 participant's 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 Student's 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 p<0.05. 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 (e.g. 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 50,000 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 www.clinicaltrials.gov.
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 person's 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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exercise training with aerobic and strength training, 30 min per session
Time frame: Tested before and after 20 weeks intervention
Self-rated in questionaire (1-10 scale)
Time frame: Tested before and after 20 weeks intervention
Self-rated in questionaire (likert scale)
Time frame: Tested before and after 20 weeks intervention
Self-rated quality of life in the questionaire EQ-5D (scale -0.624 to 1)
Time frame: Tested before and after 20 weeks intervention
Self-rated in the questionaire IPAQ (total METs scores, continous data)
Time frame: Tested before and after 20 weeks intervention
Self-rated in questionaire (NRS 0-10)
Time frame: Tested before and after 20 weeks intervention
Resting test of diastolic and systolic pressure (mmHg)
Time frame: Tested before and after 20 weeks intervention
Aastrands test (oxygen uptace pr min pr kg body weight)
Time frame: Tested before and after 20 weeks intervention
The circumferences of the hip and waist areas (cm)
Time frame: Tested before and after 20 weeks intervention
Register data for sick-leave (number of days)
Time frame: Tested before and after 20 weeks intervention
Tracked by telephones (health app, number of steps)
Time frame: Tested before and after 20 weeks intervention
Muscle strength tested in knee extension (N)
Contact information is provided by the study sponsor or research team.
Nordsjaellands Hospital
Other
Impact of Physical Exercise at a Hospital Tested in a Pilot Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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