Clinical trial NCT02780076: Recovery of Physical Functioning After Hip Fracture
Official title: Recovery of Physical Functioning, Activity Level, and Quality of Life After Hip Fracture in the Fragile Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoral Neck Fractures
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Oslo Metropolitan University
First posted: 2016-05-23
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the performance-based Short physical performance battery (SPPB)
timeFrame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Secondary outcomes:
measure: Change in the performance-based measure Timed Up & Go (TUG)
timeFrame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
measure: Change in the performance-based measure Hand grip strength
timeFrame: Change 5 days - 12 months
measure: Descriptive performance-based measurement of physical activity, an accelerometer (activPAL)
timeFrame: Descriptive from day 5 to 19 after surgery
measure: Pain in rest and while walking
timeFrame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
measure: EuroQol (European quality of life) health status measure
timeFrame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
measure: University of California Los Angeles (UCLA) activity scale
timeFrame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months
measure: New Mobility Scale (NMS)
timeFrame: Change 5 days - 12 months after surgery
measure: Walking Habits
timeFrame: Change 5 days - 3 months, change 5 days - 12 months after surgery
measure: Fall efficacy scale (FES)
timeFrame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Bærum Hospital Vestre Viken, Department of medical research
state: Drammen
Study officials:
affiliation: Bærum Hospital Vestre Viken HF
name: Kristi E Heiberg, PhD
role: STUDY_CHAIR
References:
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.
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.