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Training of Patients With Hip Fracture

Primary Purpose

Hip Fracture

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Strength training
Sponsored by
Lolland Community, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring Lower limb strength training, Randomized clinical trial, Patients with Hip fracture, 6 vs. 12 weeks physical strength training

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maribo Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

6 weeks of physical training

12 weeks of physical exercise

Arm Description

The 6 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week.

The 12 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week.

Outcomes

Primary Outcome Measures

Difference in the 6-minutes walking test
The 6-minutes walking test, performed according to international guidelines.

Secondary Outcome Measures

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
Difference in 10-meter fast speed walking test
Best of 3 timed 10 meter fast speed walk tests.
Difference in the Timed Up & Go test
Best of 3 timed TUG tests will be used.
Difference in the Short Form-36
The Questionnaire will be filled out during an interview with the patient
Difference in the New Mobility Score
The questionnaire will be filled out during an interview with the patient.

Full Information

First Posted
July 21, 2010
Last Updated
August 6, 2014
Sponsor
Lolland Community, Denmark
Collaborators
Association of Danish Physiotherapists, Copenhagen University Hospital, Hvidovre
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1. Study Identification

Unique Protocol Identification Number
NCT01174589
Brief Title
Training of Patients With Hip Fracture
Official Title
Strength Training of Patients With Hip Fracture - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lolland Community, Denmark
Collaborators
Association of Danish Physiotherapists, Copenhagen University Hospital, Hvidovre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Lower limb strength training, Randomized clinical trial, Patients with Hip fracture, 6 vs. 12 weeks physical strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6 weeks of physical training
Arm Type
Other
Arm Description
The 6 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week.
Arm Title
12 weeks of physical exercise
Arm Type
Other
Arm Description
The 12 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week.
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
to compare if there is a difference between 6 or 12 weeks of physical strength training
Primary Outcome Measure Information:
Title
Difference in the 6-minutes walking test
Description
The 6-minutes walking test, performed according to international guidelines.
Time Frame
at baseline, 6 weeks, 12 weeks (primary analysis) and 24 weeks after baseline testing
Secondary Outcome Measure Information:
Title
Difference of the Maximal isometric knee-extension strength of the fractured limb.
Description
The best of 5 maximal isometric unilateral knee-extension strength tests of both limbs, measured with a fixated handheld dynamometer
Time Frame
Baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
Title
Difference in 10-meter fast speed walking test
Description
Best of 3 timed 10 meter fast speed walk tests.
Time Frame
At baseline, 6 weeks, 12 weeks, and 24 weeks after baseline testing
Title
Difference in the Timed Up & Go test
Description
Best of 3 timed TUG tests will be used.
Time Frame
At baseline and 6 weeks, 12 weeks and 24 weeks after baseline testing
Title
Difference in the Short Form-36
Description
The Questionnaire will be filled out during an interview with the patient
Time Frame
At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
Title
Difference in the New Mobility Score
Description
The questionnaire will be filled out during an interview with the patient.
Time Frame
At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
Other Pre-specified Outcome Measures:
Title
Difference in the Barthel 0-20 points ADL-score
Description
The questionnaire will be filled out during an interview with the patient
Time Frame
At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
Title
The Tandem Balance test 0-30 points
Time Frame
At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Overgaard, MSc.
Organizational Affiliation
Sector of health, rehabilitation, Lolland community, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Morten T Kristensen, PhD
Organizational Affiliation
Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Maribo Health Center
City
Maribo
ZIP/Postal Code
4930
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
36070134
Citation
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.
Results Reference
derived
PubMed Identifier
34460897
Citation
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.
Results Reference
derived

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Training of Patients With Hip Fracture

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