NCT01007669

Brief Summary

The purpose of this study is to evaluate the effect of specified worksite physical-activity interventions on musculoskeletal disorders in an industry with physical heavy workload.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

1.3 years

First QC Date

November 3, 2009

Last Update Submit

February 8, 2013

Conditions

Musculoskeletal Diseases

Keywords

Physical activity

Outcome Measures

Primary Outcomes (2)

  • muscle strength

    3 months

  • Aerobic capacity

    3 months

Secondary Outcomes (2)

  • Questionnaire

    1 year

  • Health Check

    3 months

Study Arms (2)

Reference

ACTIVE COMPARATOR

Health check only

Behavioral: Health check only

Intervention

EXPERIMENTAL

Physical activity and Health check

Behavioral: Physical activity and Health check

Interventions

Physical activity and Health checkBEHAVIORAL

Strength training, aerobic capacity training.

Intervention
Health check onlyBEHAVIORAL

Health check

Reference

Eligibility Criteria

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

You may qualify if:

  • Constructions workers, working for more than 20 hours pr week, Physical heavy work tasks (in Danish: brolæggere, rørlæggere, mekanikere)

You may not qualify if:

  • Workers with flexible job i.e. for people with a reduced ability to work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, DK-5230, Denmark

Location

Related Publications (2)

  • Gram B, Westgate K, Karstad K, Holtermann A, Sogaard K, Brage S, Sjogaard G. Occupational and leisure-time physical activity and workload among construction workers - a randomized control study. Int J Occup Environ Health. 2016 Jan;22(1):36-44. doi: 10.1080/10773525.2016.1142724. Epub 2016 Apr 21.

    PMID: 27097799DERIVED

  • Holtermann A, Jorgensen MB, Gram B, Christensen JR, Faber A, Overgaard K, Ektor-Andersen J, Mortensen OS, Sjogaard G, Sogaard K. Worksite interventions for preventing physical deterioration among employees in job-groups with high physical work demands: background, design and conceptual model of FINALE. BMC Public Health. 2010 Mar 9;10:120. doi: 10.1186/1471-2458-10-120.

    PMID: 20214807DERIVED

MeSH Terms

Conditions

Musculoskeletal DiseasesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bibi Gram, M.Sc.,PT

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D student

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 4, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2010

Study Completion

September 1, 2011

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

DK(1)