Recovery of Physical Functioning After Hip Fracture

Femoral Neck Fractures Clinical Trial

— HIPFRAC  

Official title:

Recovery of Physical Functioning, Activity Level, and Quality of Life After Hip Fracture in the Fragile Elderly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02780076
• Other study ID #: 2015/2147
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 30, 2016
• Est. completion date: June 1, 2021

Study information

• Verified date: April 2021
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: June 1, 2021
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures

Intervention

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.

Locations

Country	Name	City	State
Norway	Bærum Hospital Vestre Viken, Department of medical research	Sandvika	Drammen

Sponsors (2)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the performance-based Short physical performance battery (SPPB)	Measurement of physical functioning	Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Secondary	Change in the performance-based measure Timed Up & Go (TUG)	Measurement of mobility	Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Secondary	Change in the performance-based measure Hand grip strength	Dynamometer	Change 5 days - 12 months
Secondary	Descriptive performance-based measurement of physical activity, an accelerometer (activPAL)	Measurement of physical activity	Descriptive from day 5 to 19 after surgery
Secondary	Pain in rest and while walking	Questionnaire	Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Secondary	EuroQol (European quality of life) health status measure	Questionnaire	Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Secondary	University of California Los Angeles (UCLA) activity scale	Questionnaire	Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months
Secondary	New Mobility Scale (NMS)	Questionnaire	Change 5 days - 12 months after surgery
Secondary	Walking Habits	Questionnaire	Change 5 days - 3 months, change 5 days - 12 months after surgery
Secondary	Fall efficacy scale (FES)	Questionnaire	Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery