NCT02780076

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

May 30, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

3.8 years

First QC Date

May 4, 2016

Last Update Submit

April 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change in the performance-based measure Timed Up & Go (TUG)

    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

    Change 5 days - 12 months

  • Descriptive performance-based measurement of physical activity, an accelerometer (activPAL)

    Descriptive from day 5 to 19 after surgery

  • Pain in rest and while walking

    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

    Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery

  • +4 more secondary outcomes

Study Arms (2)

Functional training group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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.

Functional training group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bærum Hospital Vestre Viken, Department of medical research

Sandvika, Drammen, 3004, Norway

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Kristi E Heiberg, PhD

    Bærum Hospital Vestre Viken HF

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 23, 2016

Study Start

May 30, 2016

Primary Completion

March 31, 2020

Study Completion

June 1, 2021

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations