Recovery of Physical Functioning After Hip Fracture (HIPFRAC)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Other: Functional training program

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
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Drammen
    • Sandvika, Drammen, Norway, 3004
      • Bærum Hospital Vestre Viken, Department of medical research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in the performance-based measure Hand grip strength	Dynamometer	Change 5 days - 12 months
Descriptive performance-based measurement of physical activity, an accelerometer (activPAL)	Measurement of physical activity	Descriptive from day 5 to 19 after surgery
Pain in rest and while walking	Questionnaire	Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
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
University of California Los Angeles (UCLA) activity scale	Questionnaire	Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months
New Mobility Scale (NMS)	Questionnaire	Change 5 days - 12 months after surgery
Walking Habits	Questionnaire	Change 5 days - 3 months, change 5 days - 12 months after surgery
Fall efficacy scale (FES)	Questionnaire	Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Collaborators: Oslo Metropolitan University
• Investigators: Study Chair: Kristi E Heiberg, PhD, Bærum Hospital Vestre Viken HF

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2016
• Primary Completion (Actual): March 31, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 23, 2016

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: 2015/2147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No