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Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM (FRIDOM)

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ClinicalTrials.gov Identifier: NCT02843269
Recruitment Status : Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Jeanette Reffstrup Christensen, University of Southern Denmark

Brief Summary:

Several RCT studies have aimed to reduce either musculoskeletal disorders, sickness presenteeism, sickness absenteeism or a combination of these among females with high physical work demands. These studies have provided evidence that workplace health promotion (WHP) interventions are effective, but long-term effects are still uncertain. These studies either lack to succeed in maintaining intervention effects or lack to document if effects are maintained past a one-year period. FRIDOM (FRamed Intervention to Decrease Occupational Muscle pain) is a WHP program among health care workers. A job group characterized by having high physical work demands, musculoskeletal disorders, high sickness presenteeism - and absenteeism.

FRIDOM aimed to reduce neck and shoulder pain and secondary to reduce sickness presenteeism and sickness absenteeism. An other secondary aim was to decrease lifestyle-diseases such as other musculoskeletal disorders as well as metabolic-, and cardiovascular disorders - and to maintain participation to regular physical exercise training, after a one year intervention period. The entire concept was tailored to a population of female health care workers. This was done through a multi-component intervention including 1) intelligent physical exercise training (IPET), dietary advice and weight loss (DAW) and cognitive behavioural training (CBT).


Condition or disease Intervention/treatment Phase
Neck Pain Shoulder Pain Lifestyle Behavioral: Multi-component lifestyle intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM. Background, Design and Conceptual Model of a Cluster Randomized Double-blinded Controlled Study Among Female Health Care Workers
Study Start Date : September 2014
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : May 2025

Arm Intervention/treatment
Active Comparator: Multi-component lifestyle intervention 1
A multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)
Behavioral: Multi-component lifestyle intervention
The exact same intervention was given to the three Stepped-wedge groups - but each of the three groups were started up three months apart. The waiting groups served as control groups. Thus, the intervention were for all three groups a multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)

Active Comparator: Multi-component lifestyle intervention 2
A multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)
Behavioral: Multi-component lifestyle intervention
The exact same intervention was given to the three Stepped-wedge groups - but each of the three groups were started up three months apart. The waiting groups served as control groups. Thus, the intervention were for all three groups a multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)

Active Comparator: Multi-component lifestyle intervention 3
A multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)
Behavioral: Multi-component lifestyle intervention
The exact same intervention was given to the three Stepped-wedge groups - but each of the three groups were started up three months apart. The waiting groups served as control groups. Thus, the intervention were for all three groups a multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)




Primary Outcome Measures :
  1. Neck pain intensity as assessed by a 10 point Visual Analogue Scale [ Time Frame: 12 months follow-up ]
  2. Shoulder pain intensity as assessed by a 10 point Visual Analogue Scale [ Time Frame: 12 months follow-up ]

Secondary Outcome Measures :
  1. Risk factors for lifestyle diseases - Blood pressure with an electronic blood pressure monitoring device [ Time Frame: Baseline, 1, 3 and 5 years ]
    From baseline to 1, 3 and 5 years follow-up with an electronic blood pressure monitoring device (Artsana CS 410)

  2. Risk factors for lifestyle diseases - Body fat using a bio impedance device [ Time Frame: Baseline, 1, 3 and 5 years ]
    From baseline to 1, 3 and 5 years follow-up using a bio impedance device (TANITA SC-330)

  3. Risk factors for lifestyle diseases - Waist circumference using an ergonomic circumference measuring tape [ Time Frame: Baseline, 1, 3 and 5 years ]
    From baseline to 1, 3 and 5 years follow-up using an ergonomic circumference measuring tape (Seco 203 Girth measuring tape)

  4. Risk factors for lifestyle diseases - Aerobic fitness with the Wattmax test [ Time Frame: Baseline, 1, 3 and 5 years ]
    From baseline to 1, 3 and 5 years follow-up measured with the Wattmax test using a Monark E327 bicycle ergometer and a pulse belt

  5. Sickness absence retrieved from a local database [ Time Frame: Baseline, 1, 3 and 5 years ]
    sickness absence were retrieved from a local database maintained by the executive director at the workplace, from 1 year before intervention start to 1, 3 and 5 years follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participants should be employed at the elderly care department at a Danish municipality (Sydjurs).
  2. Working at least 15 hours per week.
  3. Permanently employed, or
  4. Have at least 12 months of work left before retirement.

Exclusion Criteria:

  1. Long-term sick listed.
  2. Pregnancy, or
  3. Working at a rehabilitation center, as these employees do not have work tasks within elderly care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843269


Sponsors and Collaborators
University of Southern Denmark
Investigators
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Principal Investigator: Jeanette R Christensen, PHD University of Southern Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeanette Reffstrup Christensen, PHD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02843269    
Other Study ID Numbers: S-20130157
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jeanette Reffstrup Christensen, University of Southern Denmark:
RCT
Multi-component intervention
Health personnel
Physical exercise training
Additional relevant MeSH terms:
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Shoulder Pain
Myalgia
Neck Pain
Pain
Neurologic Manifestations
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain