NCT02014987

Brief Summary

About 31% of the Danish population participates regularly in running. The positive health benefits of running have been well documented in the literature. Unfortunately, running has been connected with a high risk of injuries. Running related injuries can cause a long rehabilitation and may even force the runner to quit running permanently. To ensure that running can be practiced as a safe exercise activity prevention must be considered.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2013

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

2.5 years

First QC Date

December 9, 2013

Last Update Submit

April 9, 2015

Conditions

Treatment ErrorOveruse Injury

Keywords

Running related injuryOveruse injuryRunning pattern

Outcome Measures

Primary Outcomes (1)

  • Running related injury

    An injury sustained on muscles, joints, tendons and/or bones during or after running. The injury must have caused a workout reduction (reduced distance, intensity, frequency etc.) for at least 7 days.

    7 days

Study Arms (1)

Running training programmes

EXPERIMENTAL

Runners with a high body mass index are going to follow a training programme of 3 kilometres per week compared to a training programme of 6 kilometres per week. The amount of running will be increased with 10 % per week.

Behavioral: Training programmes

Interventions

Training programmesBEHAVIORAL

Runners with a high body mass index follow two types of training programmes: 1. a running programme of 3 kilometres per week 2. a running programme 6 kilometres per week The amount of running will be increased with 10 % per week.

Running training programmes

Eligibility Criteria

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

You may qualify if:

  • both gender between 16-65 years
  • no running-training within the last year
  • less than 20 hours of sports activity within the last year (in total)
  • internet access and mail address
  • body mass index between 18.5 - 25 or 30-35
  • owns a pair of running shoes

You may not qualify if:

  • do not want to use a GPS watch
  • unable or unwilling to follow the running regime in 4 consecutive weeks
  • previous injury in lower extremity within the last 2 years
  • unable to read or understand Danish
  • former heart surgery
  • known heart surgery
  • known lung disease
  • diabetes
  • current pregnancy
  • known tendency to shortness of breath or chest pain with activity
  • known tendency to leg pain when walking long distances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sten Rasmussen

Aalborg, Northern Jutland, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and Injuries

Study Officials

  • Michael L. Bertelsen, PT

    Department of Publich Health, Aarhus University

    STUDY CHAIR

  • Sten Rasmussen, MD

    Northern Orthopaedic Division, Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sten Rasmussen, MD

CONTACT

sten.rasmussen@rn.dk

Michael L. Bertelsen, PT

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 19, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

DK(1)