Observation and Progressive Strength Training After Hip Fracture
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Oslo University Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Oslo University Hospital
Collaborator:
Diakonhjemmet Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01129219
First received: May 18, 2010
Last updated: May 21, 2010
Last verified: March 2007
| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 18, 2010 |
| Last Updated Date | May 21, 2010 |
| Start Date ICMJE | June 2007 |
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Bergs Balance scale [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ] 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). |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01129219 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Strength [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ] Secondary outcomes was the results on the Sit to Stand-test,which measure strength of lower limbs. |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Observation and Progressive Strength Training After Hip Fracture |
| Official Title ICMJE | Observation and Progressive Strength Training After Hip Fracture |
| 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Condition ICMJE | Exercise |
| Intervention ICMJE | Other: Strength training
Strength training for 24 weeks |
| Study Arm (s) | Experimental: Usual care
Subjects in the control group were asked to maintain their current lifestyle. No restrictions were placed on their exercise activities.
Intervention: Other: Strength training |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Enrollment ICMJE | 150 |
| Estimated Completion Date | December 2010 |
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:at 12 weeks postoperative:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 65 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT01129219 |
| Other Study ID Numbers ICMJE | 1.2007.347 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Mette Martinsen, Diakonhjemmet Sykehus |
| Study Sponsor ICMJE | Oslo University Hospital |
| Collaborators ICMJE | Diakonhjemmet Hospital |
| Investigators ICMJE | Not Provided |
| Information Provided By | Oslo University Hospital |
| Verification Date | March 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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