Training of Patients With Hip Fracture

Hip Fracture Clinical Trial

Official title:

Strength Training of Patients With Hip Fracture - a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174589
• Other study ID #: SJ-145
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2010
• Last updated: August 6, 2014
• Start date: September 2010
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Lolland Community, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to illustrate whether there is a difference in the 6 minutes walking test in patients with hip fractures who have received 6 vs. 12 weeks of physical training after discharge from hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• patients with hip fractures

• full weightbearing on the affected leg

• patients living in their own home with an independent walking ability score >=2 according to the New Mobility Score scale

• written consent

Exclusion Criteria:

• institutionalized patients

• more than 2 weeks after discharge from hospital

• non weight bearing on the affected leg

• Dementia

• other conditions/diagnosis that would have an effect on the ability to train eg. neurological diagnosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Other:
• Strength training
to compare if there is a difference between 6 or 12 weeks of physical strength training

Locations

Country	Name	City	State
Denmark	Maribo Health Center	Maribo

Sponsors (3)

Lead Sponsor	Collaborator
Lolland Community, Denmark	Association of Danish Physiotherapists, Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in the Barthel 0-20 points ADL-score	The questionnaire will be filled out during an interview with the patient	At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing	No
Other	The Tandem Balance test 0-30 points		At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing	No
Primary	Difference in the 6-minutes walking test	The 6-minutes walking test, performed according to international guidelines.	at baseline, 6 weeks, 12 weeks (primary analysis) and 24 weeks after baseline testing	No
Secondary	Difference of the Maximal isometric knee-extension strength of the fractured limb.	The best of 5 maximal isometric unilateral knee-extension strength tests of both limbs, measured with a fixated handheld dynamometer	Baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing	No
Secondary	Difference in 10-meter fast speed walking test	Best of 3 timed 10 meter fast speed walk tests.	At baseline, 6 weeks, 12 weeks, and 24 weeks after baseline testing	No
Secondary	Difference in the Timed Up & Go test	Best of 3 timed TUG tests will be used.	At baseline and 6 weeks, 12 weeks and 24 weeks after baseline testing	No
Secondary	Difference in the Short Form-36	The Questionnaire will be filled out during an interview with the patient	At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing	No
Secondary	Difference in the New Mobility Score	The questionnaire will be filled out during an interview with the patient.	At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing	No

External Links

•   The regional ethical committee