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

Status

Unknown

Conditions

Intervention / Treatment

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:

  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 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.

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

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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