- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03030092
Maximal Strength Training Following Hip Fracture Surgery: Impact on Muscle Mass, Balance, Walking Efficiency and Bone Density
July 2, 2020 updated by: Molde University College
One group will receive today's standard rehabilitation program following hip fracture surgery.
The intervention group will have maximal strength training incorporated in their program.
It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over 4 sets for leg press and abduction resistance exercise at ~85% of maximal strength is carried out.
Muscle strength, balance and bone density will be compared between the groups following the 8-week rehabilitation period.
The feasibility of the intervention for the patient group will be evaluated based on compliance with training program and possible adverse events related to the operated hip.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
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 to 95 years (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age over 65, hip fracture surgery
Exclusion Criteria:
- COPD, Heart failure, Dementia
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control group
Today's standard care
|
|
EXPERIMENTAL: Intervention group
Maximal Strength Training
|
leg pres and abduction exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle strength
Time Frame: 8 weeks
|
1RM leg press, and hip abduction
|
8 weeks
|
Balance
Time Frame: 8 weeks
|
unipedal stance test
|
8 weeks
|
Bone Density
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
- Berg OK, Stutzer JM, Hoff J, Wang E. Early Maximal Strength Training Improves Leg Strength and Postural Stability in Elderly Following Hip Fracture Surgery. Geriatr Orthop Surg Rehabil. 2021 Apr 30;12:21514593211015103. doi: 10.1177/21514593211015103. eCollection 2021.
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
January 1, 2017
Primary Completion (ACTUAL)
June 1, 2019
Study Completion (ACTUAL)
June 1, 2019
Study Registration Dates
First Submitted
January 18, 2017
First Submitted That Met QC Criteria
January 20, 2017
First Posted (ESTIMATE)
January 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 7, 2020
Last Update Submitted That Met QC Criteria
July 2, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Berg10069
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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