- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02815254
Better Hips- Better Function
October 5, 2022 updated by: Astrid Bergland, Oslo Metropolitan University
The Effect of Exercise in Elderly Hip Fracture Patients: a Clinical Randomised Trial
The focus of this project are elderly people who have experienced hip fracture and need at least two weeks rehabilitation after discharge from hospital.
The aim is to increase the evidence-based knowledge base for planning and appropriate follow-up intervention for patients with hip fracture on short-term / rehabilitation stays.
In this study the investigators want to explore whether training High Intensity Functional Exercises (HIFE) , of short duration ie a 2- 4 week program and frequent intervention ie 5 times per week has a significant positive effect on physical function, pain and quality of life.
The main aim is to explore whether a high intensive strength and balance training program has better effect than a low intensive strength and balance training program on functional status measured by Short Physical Performance Battery (SPPB) in patients with hip fractures.
Another aims is to explore whether this high intensive strength and balance training program has better effect than a 'low intensive strength and balance training program' on pain, endurance and quality of life measured respectively Numeric Pain Rating Scale (NPR), 6-minute walk test and SF-36.
The study is a randomized controlled trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Røyken, Norway, 3440
- Braseth rehabilitation centre
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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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Fractura colli femoris, pertrochantar or subtrochantar)
- Discharged from hospital within 3 weeks since surgery.
- Need of minimum two weeks rehabilitation
- Life expectancy of more than one month
- Able to walk at least 3 m with walking aid
- Willingness to participate
- Able to follow instructions
- 65 years or older
Exclusion Criteria:
-Other reasons for gait impairment than hip fracture
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Low dose exercise intervention
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Experimental: High dose exercise intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The Short Physical Performance Battery
Time Frame: November 2015 -October 2018 (up to 3 years)
|
November 2015 -October 2018 (up to 3 years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Astrid Bergland, PhD, Oslo Metropolitan University
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.
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
November 1, 2015
Primary Completion (Actual)
October 1, 2021
Study Completion (Actual)
October 1, 2021
Study Registration Dates
First Submitted
April 21, 2015
First Submitted That Met QC Criteria
June 27, 2016
First Posted (Estimate)
June 28, 2016
Study Record Updates
Last Update Posted (Actual)
October 6, 2022
Last Update Submitted That Met QC Criteria
October 5, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/1441
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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