Observation and Progressive Strength Training After Hip Fracture
Primary Purpose
Exercise
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Strength training
Sponsored by
About this trial
This is an interventional treatment trial for Exercise focused on measuring Strength, Function, Mobility
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Usual care
Arm Description
Subjects in the control group were asked to maintain their current lifestyle. No restrictions were placed on their exercise activities.
Outcomes
Primary Outcome Measures
Bergs Balance scale
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).
Secondary Outcome Measures
Strength
Secondary outcomes was the results on the Sit to Stand-test,which measure strength of lower limbs.
Full Information
NCT ID
NCT01129219
First Posted
May 18, 2010
Last Updated
May 21, 2010
Sponsor
Oslo University Hospital
Collaborators
Diakonhjemmet Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01129219
Brief Title
Observation and Progressive Strength Training After Hip Fracture
Official Title
Observation and Progressive Strength Training After Hip Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
Collaborators
Diakonhjemmet Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise
Keywords
Strength, Function, Mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Experimental
Arm Description
Subjects in the control group were asked to maintain their current lifestyle. No restrictions were placed on their exercise activities.
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
Strength training for 24 weeks
Primary Outcome Measure Information:
Title
Bergs Balance scale
Description
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).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Strength
Description
Secondary outcomes was the results on the Sit to Stand-test,which measure strength of lower limbs.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
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
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Observation and Progressive Strength Training After Hip Fracture
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