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Recovery of Physical Functioning After Hip Fracture (HIPFRAC)

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ClinicalTrials.gov Identifier: NCT02780076
Recruitment Status : Unknown
Verified May 2016 by Vestre Viken Hospital Trust.
Recruitment status was:  Not yet recruiting
First Posted : May 23, 2016
Last Update Posted : May 23, 2016
Sponsor:
Collaborator:
Oslo and Akershus University College of Applied Sciences
Information provided by (Responsible Party):
Vestre Viken Hospital Trust

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.

Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Other: Functional training program Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recovery of Physical Functioning, Activity Level, and Quality of Life After Hip Fracture in the Fragile Elderly
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Functional training group
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.
Other: Functional training program
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.

No Intervention: Control group
Usual care only. No participation in the functional training program while at short-term stays.



Primary Outcome Measures :
  1. Change in the performance-based Short physical performance battery (SPPB) [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months,1change 5 days - 12 months after surgery ]
    Measurement of physical functioning


Secondary Outcome Measures :
  1. Change in the performance-based measure Timed Up & Go (TUG) [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery ]
    Measurement of mobility

  2. Change in the performance-based measure Hand grip strength [ Time Frame: Change 5 days - 12 months ]
  3. Descriptive performance-based measurement of physical activity, an accelerometer (activPAL) [ Time Frame: Descriptive from day 5 to 19 after surgery ]
    Measurement of physical activity

  4. Pain in rest and while walking [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery ]
    Questionnaire

  5. EuroQol (European quality of life) health status measure [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery ]
    Questionnaire

  6. University of California Los Angeles (UCLA) activity scale [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months ]
    Questionnaire

  7. New Mobility Scale (NMS) [ Time Frame: Change 5 days - 12 months after surgery ]
    Questionnaire

  8. Walking Habits [ Time Frame: Change 5 days - 3 months, change 5 days - 12 months after surgery ]
    Questionnaire

  9. Fall efficacy scale (FES) [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery ]
    Questionnaire



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780076


Contacts
Contact: Kristi E Heiberg, PhD 004790980258 kristi.elisabeth.heiberg@vestreviken.no
Contact: Arnljot Tveit, PhD arnljot.tveit@vestreviken.no

Sponsors and Collaborators
Vestre Viken Hospital Trust
Oslo and Akershus University College of Applied Sciences
Investigators
Study Chair: Kristi E Heiberg, PhD Bærum Hospital Vestre Viken HF

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT02780076     History of Changes
Other Study ID Numbers: 2015/2147
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Femoral Neck Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries