NCT02029131

Brief Summary

Evaluation of the effectiveness of an individually educated exercise program for the lower back at home in employees over a period of 20 weeks. We hypothesize that regular exercise for the lower back results in greater improvements of low back strengths compared to controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

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

January 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

January 3, 2014

Last Update Submit

February 22, 2017

Conditions

Healthy Volunteers With and Without Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Back strength (kg)

    Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention)

    At baseline and after 20 weeks

Secondary Outcomes (8)

  • Strenght at lateral flexion of the trunk (kg)

    At baseline and after 20 weeks

  • Oswestry Low Back Pain Disability Score

    At baseline and after 20 weeks

  • Pain (scale)

    At baseline and after 20 weeks

  • Quality of life (score)

    At baseline and after 20 weeks

  • Work ability index (score)

    At baseline and afetr 20 weeks

  • +3 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL
Behavioral: Exercise

Controls

NO INTERVENTION

Interventions

ExerciseBEHAVIORAL

Educated exercise training for the trunk 3 times per week, each for 20 min. Recommendation of additional fitness courses as offered by the local healthy insurance company.

Exercise

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women
  • age between 18 and 67 years

You may not qualify if:

  • beeing currently involved in an exercise program for the lower back
  • known drug or alcohol abuse
  • any disease that excludes the participation in an exercise program
  • clinical relevant acute or chronic infections
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (1)

  • Bayerle P, Kerling A, Kuck M, Rolff S, Boeck HT, Sundermeier T, Ensslen R, Tegtbur U, Lauenstein D, Bothig D, Bara C, Hanke A, Terkamp C, Haverich A, Stiesch M, de Zwaan M, Haufe S, Nachbar L. Effectiveness of wearable devices as a support strategy for maintaining physical activity after a structured exercise intervention for employees with metabolic syndrome: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2022 Feb 10;14(1):24. doi: 10.1186/s13102-022-00409-1.

    PMID: 35144658DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. rer. medic.

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 7, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

February 1, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

DE(1)