Strength Training After Hip Fracture Surgery

Hip Fracture Clinical Trial

Official title:

Effect of Rehabilitation With Versus Without Progressive Strength Training Implemented in the Acute Ward After Hip Fracture Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848913
• Other study ID #: H-A-2007-0127 + 37036
• Status: Completed
• Phase: N/A
• First received: February 19, 2009
• Last updated: June 2, 2015
• Start date: October 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effect of progressive strength training of the fractured limb in patients with hip fracture, during admittance in an acute orthopedic ward. The primary study hypothesis is that the training will reduce the strength deficit in the fractured limb in comparison with the non-fractured limb. Secondary, that patients following the intervention will present larger improvements in physical function compared to controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Primary hip fracture surgery

• 65 years or older

• Speak and understand the Danish language

• Able to give informed consent

• Home-dwelling with and independent prefracture indoor walking ability equal to New Mobility Score >=2

Exclusion Criteria:

• Multiple fractures

• Weightbearing restrictions

• Patient unwilling to participate in appropriate rehabilitation

• Not able to cooperate to tests

• Terminal illness

• Patients who want an observer present at the information interview, but where such one is not available.

• Patients with a cervical hip fracture treated with Total Hip Arthroplasty or hip pins, due to expected short length of hospital stay.

Study Design

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Other:
• Rehabilitation with strength training
Basic mobility and exercise therapy following a guideline with 12 specific exercises, progressed individually, and supplemented with progressive knee-extension strength training (10RM) of the fractured limb using ankle weight cuffs, daily during hospital stay.
• Rehabilitation without strength training
Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.

Locations

Country	Name	City	State
Denmark	Department of Orthopedic Surgery hvidovre hospital	Hvidovre	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	10 meter fast speed, Cumulated Ambulation Score.	Cumulated Ambulation Score is recorded every day from inclusion to discharge. 10 meter fast speed is assessed at postoperative day 10 and/or discharge.	At discharge and during in-hospital stay.	No
Other	Short Falls Efficacy Scale-International (Short FES-I)	A questionnaire evaluation of the patient's subjective concern at the moment for falling related to 7 different physical functions. Score 7-28, with maximum score expressing very high concern of falling in all 7 physical functions.	At discharge	No
Other	Verbal Ranking Scale (VRS)	Evaluation of experienced hip-fracture related pain at rest and during strength training and testing.	During in-hospital stay.	No
Other	24-hour activity	24-hour sit/lie and stand/walk activity measured by a ActivPAL3 activity monitor (PAL Technologies Ltd, Scotland) attached to the patient's non-fractured thigh.	From inclusion to discharge	No
Primary	Knee-extension strength in the fractured limb in comparison with the non-fractured limb.	Maximal isometric knee-extension strength in the fractured limb in percentage of non-fractured limb. Isometric knee-extension strength will be measured using an externally fixated handheld dynamometer (Power Track II Commander; JTech Medical, Utah). A stap will be attached to the bed/chair and the patient's ankle (perpendicular to the lower leg), ensuring 90 degrees of knee flexion and an isometric contraction. The transducer will be placed under the strap at ankle level, just proximal to the malleolus, and the participant will be asked to extend the leg as forcefully as possible. Knee-extension strength will be expressed as the maximal voluntary torque per kilo body mass ([NIm]/kg), using the distance between the lateral femoral epicondyle and the center of the transducer and the body mass of each patient. The best of 4 trials for each limb will be used in analyses. The primary analysis will follow the intention-to-treat principle (last observation carried forward).	At inclusion, at postoperative day 10 and/or at discharge.	No
Secondary	Timed up and go test	Timed Up and Go test is assessed as early as possible during in-hospital stay and at discharge.	From inclusion to postoperative day 10 and/or discharge	No