Recovery of Physical Functioning After Hip Fracture (HIPFRAC)
Primary Purpose
Femoral Neck Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Functional training program
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fractures
Eligibility Criteria
Inclusion Criteria:
- Patients with an acute low-energy hip fracture (intracapsular, trochanteric or subtrochanteric) and treated surgically, ≥ 65 years of age, living in their own homes prior to the fracture, and able to give an informed consent.
Exclusion Criteria:
- Patients unable to walk 10 meters with or without a walking aid prior to the fracture, have a score of less than 15 points on Minimal Mental Status Evaluation (MMS-E) in the acute phase, have a pathological fracture, life expectancies of less than three months, medical contraindications for training, or are incapable of understanding and speaking the Norwegian language.
Sites / Locations
- Bærum Hospital Vestre Viken, Department of medical research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Functional training group
Control group
Arm Description
Participation in a functional training program in addition to usual care. The functional training program is initiated by the nurses and consists of walking, sit-to-stands, balance training, weight transfer training, knee squats. The program is performed 4 times a day for 3 weeks while at short-term stays.
Usual care only. No participation in the functional training program while at short-term stays.
Outcomes
Primary Outcome Measures
Change in the performance-based Short physical performance battery (SPPB)
Measurement of physical functioning
Secondary Outcome Measures
Change in the performance-based measure Timed Up & Go (TUG)
Measurement of mobility
Change in the performance-based measure Hand grip strength
Dynamometer
Descriptive performance-based measurement of physical activity, an accelerometer (activPAL)
Measurement of physical activity
Pain in rest and while walking
Questionnaire
EuroQol (European quality of life) health status measure
Questionnaire
University of California Los Angeles (UCLA) activity scale
Questionnaire
New Mobility Scale (NMS)
Questionnaire
Walking Habits
Questionnaire
Fall efficacy scale (FES)
Questionnaire
Full Information
NCT ID
NCT02780076
First Posted
May 4, 2016
Last Updated
April 14, 2021
Sponsor
Vestre Viken Hospital Trust
Collaborators
Oslo Metropolitan University
1. Study Identification
Unique Protocol Identification Number
NCT02780076
Brief Title
Recovery of Physical Functioning After Hip Fracture
Acronym
HIPFRAC
Official Title
Recovery of Physical Functioning, Activity Level, and Quality of Life After Hip Fracture in the Fragile Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2016 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vestre Viken Hospital Trust
Collaborators
Oslo Metropolitan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The survivors after hip fracture often report severe pain and loss of physical functioning. The poor outcomes cause negative impact on the person's physical functioning and quality of life and put a financial burden on society. It is important to continue and progress the functional training that already started at the hospital, while the patients are transferred to short-term stays in a nursing home before they are returning to home. The aim presently is to examine the effects of a functional training program by a RCT design, initiated by the physiotherapist and performed by the nurses, on physical functioning while the patients are at short term stays in primary health care.
Detailed Description
Functional training, such as walking and transfers, ought to be an important part of the rehabilitation after hip fracture. We have an assumption that it is of utmost importance to continue and progress the functional training that started in the acute phase at the hospital, also during the sub-acute phase while the patients are at short-term stays in nursing homes. However, there are indications of lack of resources in the nursing homes and that the nurses may be less concerned with their role and participation in the patients' rehabilitation process. Possibly, this creates a discontinuity in the rehabilitation efforts during short-term stays that may have a negative impact on the patients' recovery of physical functioning.
In this study the aim is to continue and progress the functional training started during hospital stay, such as training in walking and further on repetitive sit-to-stands, as part of the daily habitual routine during short-term stays in the nursing homes. This type of functional training may be motivational and easily recognizable to the patients, and it can also be carried out by the nursing staff with only initial guiding from a physiotherapist. There is lack of knowledge on the effect of additional functional training, incorporated as part of the habitual daily routine during short-term stays, on the patients' immediate and long term recovery of physical functioning and activity level after hip fracture, compared to usual care alone.
The study is designed as a single-blind randomized controlled trial (RCT), comparing the effects of additional functional training (functional training group)to usual care alone (control group) during short-term stays in nursing homes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional training group
Arm Type
Experimental
Arm Description
Participation in a functional training program in addition to usual care. The functional training program is initiated by the nurses and consists of walking, sit-to-stands, balance training, weight transfer training, knee squats. The program is performed 4 times a day for 3 weeks while at short-term stays.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care only. No participation in the functional training program while at short-term stays.
Intervention Type
Other
Intervention Name(s)
Functional training program
Intervention Description
Patients treated for hip fracture participate in a functional training program during their short-term stays at nursing homes. The program is initiated by the nurses 4 times a day for 3 weeks as part of the habitual routine.
Primary Outcome Measure Information:
Title
Change in the performance-based Short physical performance battery (SPPB)
Description
Measurement of physical functioning
Time Frame
Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Secondary Outcome Measure Information:
Title
Change in the performance-based measure Timed Up & Go (TUG)
Description
Measurement of mobility
Time Frame
Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Title
Change in the performance-based measure Hand grip strength
Description
Dynamometer
Time Frame
Change 5 days - 12 months
Title
Descriptive performance-based measurement of physical activity, an accelerometer (activPAL)
Description
Measurement of physical activity
Time Frame
Descriptive from day 5 to 19 after surgery
Title
Pain in rest and while walking
Description
Questionnaire
Time Frame
Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Title
EuroQol (European quality of life) health status measure
Description
Questionnaire
Time Frame
Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Title
University of California Los Angeles (UCLA) activity scale
Description
Questionnaire
Time Frame
Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months
Title
New Mobility Scale (NMS)
Description
Questionnaire
Time Frame
Change 5 days - 12 months after surgery
Title
Walking Habits
Description
Questionnaire
Time Frame
Change 5 days - 3 months, change 5 days - 12 months after surgery
Title
Fall efficacy scale (FES)
Description
Questionnaire
Time Frame
Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with an acute low-energy hip fracture (intracapsular, trochanteric or subtrochanteric) and treated surgically, ≥ 65 years of age, living in their own homes prior to the fracture, and able to give an informed consent.
Exclusion Criteria:
Patients unable to walk 10 meters with or without a walking aid prior to the fracture, have a score of less than 15 points on Minimal Mental Status Evaluation (MMS-E) in the acute phase, have a pathological fracture, life expectancies of less than three months, medical contraindications for training, or are incapable of understanding and speaking the Norwegian language.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristi E Heiberg, PhD
Organizational Affiliation
Bærum Hospital Vestre Viken HF
Official's Role
Study Chair
Facility Information:
Facility Name
Bærum Hospital Vestre Viken, Department of medical research
City
Sandvika
State/Province
Drammen
ZIP/Postal Code
3004
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33506973
Citation
Beckmann M, Bruun-Olsen V, Pripp AH, Bergland A, Smith T, Heiberg KE. Effect of an additional health-professional-led exercise programme on clinical health outcomes after hip fracture. Physiother Res Int. 2021 Apr;26(2):e1896. doi: 10.1002/pri.1896. Epub 2021 Jan 28.
Results Reference
derived
PubMed Identifier
28095787
Citation
Heiberg KE, Bruun-Olsen V, Bergland A. The effects of habitual functional training on physical functioning in patients after hip fracture: the protocol of the HIPFRAC study. BMC Geriatr. 2017 Jan 17;17(1):23. doi: 10.1186/s12877-016-0398-8.
Results Reference
derived
Learn more about this trial
Recovery of Physical Functioning After Hip Fracture
We'll reach out to this number within 24 hrs