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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01616030
Other study ID # HH-S-1
Secondary ID
Status Completed
Phase N/A
First received June 5, 2012
Last updated May 14, 2014
Start date June 2012
Est. completion date March 2013

Study information

Verified date May 2014
Source Copenhagen University Hospital, Hvidovre
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

Patients treated surgically for a hip fracture have a need of rehabilitation for the regain of former functional skills. Despite an optimized fast track in-hospital rehabilitation program it has been found that patients with hip fracture within 2 weeks after the hip fracture loose more than half of their muscle strength in the fractured limb compared to non-fractured limb. New studies including patients with total hip arthroplasty and strength training applied early after surgery has shown promising results regarding prevention of loss of muscle strength. No similar study has been found including patients with hip fracture.

The purpose of this study is to examine the feasibility of progressive knee-extension strength training of the hip fractured limb, starting Day 1 after surgical treatment for a hip fracture and proceeded every weekday during their hospital stay.

The study will include 20 patients surgically treated for a cervical hip fracture and 20 patients surgically treated for an intertrochanteric or subtrochanteric fracture. All patients are admitted from their own home. Age 60 years or older.


Description:

Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT (2014) Feasibility of Progressive Strength Training Implemented in the Acute Ward after Hip Fracture Surgery. PLoS ONE 9(4): e93332. doi:10.1371/journal.pone.0093332


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Hip fracture diagnosed patients age =60 years, admitted to the acute hip fracture unit.

- Medial femoral neck fracture, pertrochanteric fracture or subtrochanteric fracture.

- Ability to speak and understand the Danish language.

- Cognitively well-preserved and able to give personal informed consent no later than by 5th post surgical day.

- Home-residing and with an independent pre-fracture ability to walk equal to New Mobility Score at = 2 indoor.

Exclusion Criteria:

- Multiple fractures

- Postsurgical restrictions of mobilization

- Patient not accepting participation in relevant exercise therapy

- Fracture caused by cancer metastases

- Terminal illness

- Neurological impairment e.g. hemi paresis.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Knee-extension strength training of the fractured limb
Daily knee-extension strength training with 3 x 10 repetitions using an intensity of 10 Repetition Maximum (RM) for the hip fractured limb started as soon as possible after surgery.

Locations

Country Name City State
Denmark Copenhagen University Hospital, Hvidovre Hvidovre

Sponsors (1)

Lead Sponsor Collaborator
Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Kronborg L, Bandholm T, Palm H, Kehlet H, Kristensen MT. Feasibility of progressive strength training implemented in the acute ward after hip fracture surgery. PLoS One. 2014 Apr 3;9(4):e93332. doi: 10.1371/journal.pone.0093332. eCollection 2014. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Association between 10 meter fast speed walk and knee-extension strength discharge from hospital. Day before discharge from hospital. No
Primary Feasibility of progression in training loads (kg) during daily knee-extension strength training when commenced immediately after hip fracture surgery. Feasibility is evaluated on the basis of adherence to program, adverse events, target training intensity, hip pain during training and other potential restricting factors, e.g. confusion, exhaustion and dropouts. Baseline to discharge, in average 10 days. No
Secondary Change in maximum isometric knee-extension strength and strength deficits, fractured % of non-fractured limb measured by handheld dynamometer. Baseline to discharge, in average 10 days. No
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