Recovery of Physical Functioning After Hip Fracture (HIPFRAC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02780076|
Recruitment Status : Unknown
Verified May 2016 by Vestre Viken Hospital Trust.
Recruitment status was: Not yet recruiting
First Posted : May 23, 2016
Last Update Posted : May 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Femoral Neck Fractures||Other: Functional training program||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Recovery of Physical Functioning, Activity Level, and Quality of Life After Hip Fracture in the Fragile Elderly|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
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.
- Change in the performance-based Short physical performance battery (SPPB) [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months,1change 5 days - 12 months after surgery ]Measurement of physical functioning
- Change in the performance-based measure Timed Up & Go (TUG) [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery ]Measurement of mobility
- Change in the performance-based measure Hand grip strength [ Time Frame: Change 5 days - 12 months ]
- Descriptive performance-based measurement of physical activity, an accelerometer (activPAL) [ Time Frame: Descriptive from day 5 to 19 after surgery ]Measurement of physical activity
- Pain in rest and while walking [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery ]Questionnaire
- EuroQol (European quality of life) health status measure [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery ]Questionnaire
- University of California Los Angeles (UCLA) activity scale [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months ]Questionnaire
- New Mobility Scale (NMS) [ Time Frame: Change 5 days - 12 months after surgery ]Questionnaire
- Walking Habits [ Time Frame: Change 5 days - 3 months, change 5 days - 12 months after surgery ]Questionnaire
- Fall efficacy scale (FES) [ Time Frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery ]Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780076
|Contact: Kristi E Heiberg, PhDfirstname.lastname@example.org|
|Contact: Arnljot Tveit, PhDemail@example.com|
|Study Chair:||Kristi E Heiberg, PhD||Bærum Hospital Vestre Viken HF|