Training of Patients With Hip Fracture

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fracture
• Intervention / Treatment: Other: Strength training

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Maribo, Denmark, 4930
    • Maribo Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 6 weeks of physical training; The 6 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week.	Other: Strength training; to compare if there is a difference between 6 or 12 weeks of physical strength training
OTHER: 12 weeks of physical exercise; The 12 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week.	Other: Strength training; to compare if there is a difference between 6 or 12 weeks of physical strength training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The Tandem Balance test 0-30 points		At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing

Collaborators and Investigators

• Sponsor: Lolland Community, Denmark
• Collaborators: Copenhagen University Hospital, Hvidovre; Association of Danish Physiotherapists
• Investigators: Principal Investigator: Jan Overgaard, MSc., Sector of health, rehabilitation, Lolland community, Denmark; Study Director: Morten T Kristensen, PhD, Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark

Publications and helpful links

General Publications

• Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
• Overgaard JA, Kallemose T, Mangione KK, Kristensen MT. Six Versus 12 Weeks of Outpatient Physical Therapy Including Progressive Resistance Training in Cognitively Intact Older Adults After Hip Fracture: A Multicenter Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2022 Jul 5;77(7):1455-1462. doi: 10.1093/gerona/glab256.

Helpful Links

• The regional ethical committee

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (ESTIMATE): August 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 7, 2014
• Last Update Submitted That Met QC Criteria: August 6, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Lower limb strength training; Patients with Hip fracture; 6 vs. 12 weeks physical strength training
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: SJ-145