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Early Strength Training After Hip Fracture Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lise Kronborg, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT01616030
First received: June 5, 2012
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Hip Fractures
 Other: Knee-extension strength training of the fractured limb

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Progressive Strength Training in the Early Post Surgical Rehabilitation Period After Hip Fracture Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Copenhagen University Hospital, Hvidovre:

Primary Outcome Measures:
  • Feasibility of progression in training loads (kg) during daily knee-extension strength training when commenced immediately after hip fracture surgery. [ Time Frame: Baseline to discharge, in average 10 days. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in maximum isometric knee-extension strength and strength deficits, fractured % of non-fractured limb measured by handheld dynamometer. [ Time Frame: Baseline to discharge, in average 10 days. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Association between 10 meter fast speed walk and knee-extension strength discharge from hospital. [ Time Frame: Day before discharge from hospital. ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: June 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strength training, fractured limb

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
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616030

Locations
Denmark
Copenhagen University Hospital, Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Investigators
Study Director: Morten T Kristensen, PhD Copenhagen University Hospital at Hvidovre, Denmark
  More Information

No publications provided

Responsible Party: Lise Kronborg, Project Physiotherapist, Msc., Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT01616030     History of Changes
Other Study ID Numbers: HH-S-1
Study First Received: June 5, 2012
Last Updated: March 12, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Copenhagen University Hospital, Hvidovre:
Hip fractures
Strength training

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 16, 2013