Clinical trial NCT01174589: Training of Patients With Hip Fracture
Official title: Strength Training of Patients With Hip Fracture - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hip Fracture
Keywords: Lower limb strength training
Randomized clinical trial
Patients with Hip fracture
6 vs. 12 weeks physical strength training
Lead sponsor: Lolland Community, Denmark
Sponsor class: OTHER
Collaborators: name: Association of Danish Physiotherapists
name: Copenhagen University Hospital, Hvidovre
First posted: 2010-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Difference in the 6-minutes walking test
timeFrame: at baseline, 6 weeks, 12 weeks (primary analysis) and 24 weeks after baseline testing
Secondary outcomes:
measure: Difference of the Maximal isometric knee-extension strength of the fractured limb.
timeFrame: Baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
measure: Difference in 10-meter fast speed walking test
timeFrame: At baseline, 6 weeks, 12 weeks, and 24 weeks after baseline testing
measure: Difference in the Timed Up & Go test
timeFrame: At baseline and 6 weeks, 12 weeks and 24 weeks after baseline testing
measure: Difference in the Short Form-36
timeFrame: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
measure: Difference in the New Mobility Score
timeFrame: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
Other outcomes:
measure: Difference in the Barthel 0-20 points ADL-score
timeFrame: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
measure: The Tandem Balance test 0-30 points
timeFrame: At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing
Locations:
city: Maribo
country: Denmark
facility: Maribo Health Center
Study officials:
affiliation: Sector of health, rehabilitation, Lolland community, Denmark
name: Jan Overgaard, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark
name: Morten T Kristensen, PhD
role: STUDY_DIRECTOR
References:
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.
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.