Training of Patients With Hip Fracture
This study is currently recruiting participants.
Verified March 2013 by Lolland Community, Denmark
Sponsor:
Lolland Community, Denmark
Collaborators:
Denmark: Association of Danish Physiotherapists
Copenhagen University Hospital, Hvidovre
Information provided by (Responsible Party):
Mr. Jan Overgaard, Lolland Community, Denmark
ClinicalTrials.gov Identifier:
NCT01174589
First received: July 21, 2010
Last updated: March 26, 2013
Last verified: March 2013
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Purpose
The primary purpose of this study is to illustrate whether there is a difference in patients with hip fractures who have received 6 vs. 12 weeks of physical training after discharge from hospital.
| Condition | Intervention | Phase |
|---|---|---|
|
Hip Fracture |
Other: Strength training |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Strength Training of Patients With Hip Fracture - a Randomized Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Lolland Community, Denmark:
Primary Outcome Measures:
- Changes in 6-minutes walking test after 6 and 12 weeks of strength training in patients with hip fracture [ Time Frame: 24 weeks after baseline testing ] [ Designated as safety issue: No ]The 6-minutes walking test, performed according to international quidelines will be performed at baseline, and at 6, 12 and 24 weeks thereafter.
Secondary Outcome Measures:
- Changes in Knee-extension strength of the fractured limb after 6 versus 12 weeks of strength training. [ Time Frame: 24 weeks after baseline testing ] [ Designated as safety issue: No ]The best of 5 maximal isometric unilateral knee-extension strength tests of both limbs, measured with a handheld dynamometre at baseline, and at 6, 12 and 24 weeks will be used in analysis
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
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
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174589
Locations
| Denmark | |
| Maribo Health Center | Recruiting |
| Maribo, Denmark, 4930 | |
| Contact: Jan Overgaard, Bachelor +4554676942 jover@lolland.dk | |
| Contact: Pernille Pasquali, Master +4554676945 pepa@lolland.dk | |
| Principal Investigator: Jan Overgaard, Bachelor | |
Sponsors and Collaborators
Lolland Community, Denmark
Denmark: Association of Danish Physiotherapists
Copenhagen University Hospital, Hvidovre
Investigators
| Principal Investigator: | Jan Overgaard, Bachelor | 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Mr. Jan Overgaard, Physiotherapist, Bachelor, Sector of Health, Rehabilitation, Lolland Community., Lolland Community, Denmark |
| ClinicalTrials.gov Identifier: | NCT01174589 History of Changes |
| Other Study ID Numbers: | SJ-145 |
| Study First Received: | July 21, 2010 |
| Last Updated: | March 26, 2013 |
| Health Authority: | Denmark: National Board of Health Denmark: Danish Dataprotection Agency |
Keywords provided by Lolland Community, Denmark:
|
Lower limb strength training Randomized clinical trial Patients with Hip fracture 6 vs. 12 weeks physical 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 21, 2013