Recovery of Physical Functioning After Hip Fracture

NCT ID: NCT02780076

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-30
• Study Completion Date: 2021-06-01

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.

Conditions

Femoral Neck Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Functional training program

Intervention Type: OTHER

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo Metropolitan University

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristi E Heiberg, PhD

Role: STUDY_CHAIR

Bærum Hospital Vestre Viken HF

Locations

Bærum Hospital Vestre Viken, Department of medical research

Sandvika, Drammen, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 33506973 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28095787 (View on PubMed)

Other Identifiers

2015/2147

Identifier Type: -

Identifier Source: org_study_id