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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01129219
Other study ID # 1.2007.347
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 18, 2010
Last updated May 21, 2010
Start date June 2007
Est. completion date December 2010

Study information

Verified date March 2007
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date December 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:at 12 weeks postoperative:

1. age at least 65 years

2. not living in nursing home

3. were able to undergo physical therapy for the hip fracture

4. scoring of 23 or more (out of 30) on the Mini Mental State Examination

Exclusion Criteria:

1. permanently institutionalized

2. had metastatic cancer

3. suffered from multi-trauma.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Strength training
Strength training for 24 weeks

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital Diakonhjemmet Hospital

References & Publications (1)

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; Marybet

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 24 weeks Yes
Secondary Strength Secondary outcomes was the results on the Sit to Stand-test,which measure strength of lower limbs. 24 weeks Yes
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