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Maximal Strength Training Following Hip Fracture Surgery: Impact on Muscle Mass, Balance, Walking Efficiency and Bone Density

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030092
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Central Norway Regional Health Authority
Information provided by (Responsible Party):
Molde University College

Tracking Information
First Submitted Date  ICMJE January 18, 2017
First Posted Date  ICMJE January 24, 2017
Last Update Posted Date July 7, 2020
Study Start Date  ICMJE January 2017
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
  • Muscle strength [ Time Frame: 8 weeks ]
    1RM leg press, and hip abduction
  • Balance [ Time Frame: 8 weeks ]
    unipedal stance test
  • Bone Density [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • Walking efficiency [ Time Frame: 8 weeks ]
    Ergospirometry during walking on treadmill, to determine oxygen cost of a given workload
  • Muscle mass [ Time Frame: 8 weeks ]
  • Bone Density [ Time Frame: 8 weeks ]
  • Balance [ Time Frame: 8 weeks ]
    unipedal stance test
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maximal Strength Training Following Hip Fracture Surgery: Impact on Muscle Mass, Balance, Walking Efficiency and Bone Density
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rehabilitation
Intervention  ICMJE Other: Maximal Strength Training
leg pres and abduction exercises
Study Arms  ICMJE
  • No Intervention: Control group
    Today's standard care
  • Experimental: Intervention group
    Maximal Strength Training
    Intervention: Other: Maximal 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 Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2020)		 27
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2017)		 40
Actual Study Completion Date  ICMJE June 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age over 65, hip fracture surgery

Exclusion Criteria:

  • COPD, Heart failure, Dementia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 95 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03030092
Other Study ID Numbers  ICMJE Berg10069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Molde University College
Study Sponsor  ICMJE Molde University College
Collaborators  ICMJE Central Norway Regional Health Authority
Investigators  ICMJE Not Provided
PRS Account Molde University College
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP