NCT04988724

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 (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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable pain

Timeline
6mo left

Started Apr 2022

Longer than P75 for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Apr 2022Dec 2026

First Submitted

Initial submission to the registry

June 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

April 16, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

1.7 years

First QC Date

June 29, 2021

Last Update Submit

June 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes of work productivity

    Self-rated in questionaire (1-10 scale)

    Tested before and after 20 weeks intervention

Secondary Outcomes (10)

  • Changes of personal well-being

    Tested before and after 20 weeks intervention

  • Changes of quality of life

    Tested before and after 20 weeks intervention

  • Changes in self-rated physical activity

    Tested before and after 20 weeks intervention

  • Changes of muscoloskeletal pain

    Tested before and after 20 weeks intervention

  • Changes of blood pressure

    Tested before and after 20 weeks intervention

  • +5 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention group that receive 30 min exercise training twice weekly in 20 weeks

Behavioral: Exercise training

Interventions

Exercise training with aerobic and strength training, 30 min per session

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Employed nurses, doctors, secretaries and other staff on Nordsjællands Hospital, Denmark

You may not qualify if:

  • \- If exercise training is not allowed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nordsjællands Hospital

Hillerød, Capital Region, 3400, Denmark

RECRUITING

Nordsjællands Hospital

Hillerød, Hillerød, 3400, Denmark

RECRUITING

Related Publications (1)

  • Nielsen SG, Pedersen M, Toftager-Oster JU, Saervoll CA, Fischer TK, Lindegaard B, Molsted S. Feasibility and Effects of Exercise During Working Hours in Acute Hospital Staff - A Non-Randomized Controlled Trial. J Occup Rehabil. 2025 Feb 18. doi: 10.1007/s10926-025-10275-6. Online ahead of print.

MeSH Terms

Conditions

PainHealth Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stig Mølsted, PhD

    Department of Clinical Research, Nordsjællands Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stig Mølsted, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Pilot study without control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 29, 2021

First Posted

August 3, 2021

Study Start

April 16, 2022

Primary Completion

December 18, 2023

Study Completion (Estimated)

December 31, 2026

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations