NCT01616030

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 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

June 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

9 months

First QC Date

June 5, 2012

Last Update Submit

May 14, 2014

Conditions

Keywords

Hip fracturesStrength training

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • 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.

Other Outcomes (1)

  • Association between 10 meter fast speed walk and knee-extension strength discharge from hospital.

    Day before discharge from hospital.

Study Arms (1)

Strength training, fractured limb

EXPERIMENTAL

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.

Other: Knee-extension strength training of the fractured limb

Interventions

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.

Strength training, fractured limb

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

Location

Related 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.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Morten T Kristensen, PhD

    Copenhagen University Hospital at Hvidovre, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Physiotherapist, Msc.

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 11, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 15, 2014

Record last verified: 2014-05

Locations