- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01129219
Observation and Progressive Strength Training After Hip Fracture
May 21, 2010 updated by: Oslo University Hospital
This is a randomized, controlled; single-blind parallel group trial carried out with hip fracture patients, starting at 12 weeks post fracture.
Patients were approached during their acute stay in hospital, followed without any extra intervention for 12 weeks, and then randomized in a 2:1 manner to either intervention or control for the next 12 weeks.
After the first 12 weeks intervention the intervention group were divided into two groups and randomized to an new single-blind parallel group trial for further intervention.
Study Overview
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:at 12 weeks postoperative:
- age at least 65 years
- not living in nursing home
- were able to undergo physical therapy for the hip fracture
- scoring of 23 or more (out of 30) on the Mini Mental State Examination
Exclusion Criteria:
- permanently institutionalized
- had metastatic cancer
- suffered from multi-trauma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Usual care
Subjects in the control group were asked to maintain their current lifestyle.
No restrictions were placed on their exercise activities.
|
Strength training for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bergs Balance scale
Time Frame: 24 weeks
|
Bergs Balance Scale: The Berg balance scale (BBS) measures "functional balance," which has three dimensions: maintenance of a position, postural adjustment to voluntary movements, and reaction to external disturbance, scored 0-56 (Berg K. 1995).
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength
Time Frame: 24 weeks
|
Secondary outcomes was the results on the Sit to Stand-test,which measure strength of lower limbs.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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.
- Helen H Host, David R Sinacore, Kathryn L Bohnert, Karen Steger-May, Marybeth Brown and Ellen F Binder. Training-Induced Strength and Functional Adaptations After Hip Fracture. PHYS THER Vol. 87, No. 3, March 2007, pp. 292-303 Ellen F. Binder, MD; Marybeth Brown, PT, PhD; David R. Sinacore, PT, PhD; Karen Steger-May, MA; Kevin E. Yarasheski, PhD; Kenneth B. Schechtman. Effects of Extended Outpatient Rehabilitation After Hip Fracture. A Randomized Controlled Trial JAMA. 2004;292:837-846. Kathleen K Mangione, Rebecca L Craik, Susan S Tomlinson and Kerstin M Palombaro. Can Elderly Patients Who Have Had a Hip Fracture Perform Moderate- to High-Intensity Exercise at Home? PHYS THER Vol. 85, No. 8, August 2005, pp. 727-739 Klaus Hauer, Norbert Specht, Matthias Schuler, Peter Bärtsch1 and Peter Oster. Intensive physical training in geriatric patients after severe falls and hip surgery. Age and Ageing 2002; 31: 49-57 2002. David Moher1 , Kenneth F Schulz2 and Douglas G Altman. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Medical Research Methodology 2001, 1:2doi:10.1186/1471-2288-1-2 Berg K, Wood-Dauphinee S, Williams JI. The Balance Scale: reliability assessment with elderly residents and patients with an acute stroke. Scand J Rehabil Med. 1995 Mar;27(1):27-36. Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. Podsiadlo D, Richardson S. The timed
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Anticipated)
June 1, 2010
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
May 18, 2010
First Submitted That Met QC Criteria
May 21, 2010
First Posted (Estimate)
May 24, 2010
Study Record Updates
Last Update Posted (Estimate)
May 24, 2010
Last Update Submitted That Met QC Criteria
May 21, 2010
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.2007.347
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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