- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02088437
High Intensity Physiotherapy for Hip Fractures (HIP4hips)
High Intensity Physiotherapy for Hip Fractures in the Acute Hospital Setting
Every day, more than 40 Australian break their hip, Most are over the age of sixty five. Hip fractures are a significant problem for the older people, the hospital system and community as a whole because of the increasing numbers of fractures and the cost of hospitalisation and ongoing care. After one year, less than half of all people with a hip fracture can walk as well as they did before the fracture. Physiotherapy in the acute hospital setting is an integral part of patient care, although the intensity of physiotherapy a patient receives is variable and the optimal number of treatment sessions per day remains unknown. Studies in other patient groups have shown that increased physiotherapy can improve patient outcomes by increasing muscle strength and mobility. It can also reduce the negative effects of bed rest such as muscle wasting, blood clots in the lungs or leg veins and chest infections such as pneumonia. This study aims to investigate the effectiveness of an intensive physiotherapy program in hip fracture patients to further understand this and the effect it has on patient function.
In this research the investigators will randomly allocate patients into 2 groups; usual care and intensive physiotherapy. The usual care group will have physiotherapy treatment daily whereas the intensive physiotherapy group will have an additional daily treatment by a physiotherapist as well as a daily treatment by an allied health assistant. The objectives are to achieve better functional outcomes in the patient's hospital stay (ie improved mobility), reduce the time for patients to be physically ready to go home, increase the number of patients able to go directly home or to fast stream rehabilitation (rather than a slow stream option).
If increased intensity of physiotherapy is found to improve patient's mobility outcomes, this research will provide the confidence to endorse a change to current clinical practice.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Victoria
-
Melbourne, Victoria, Australien, 3181
- The Alfred
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Admission to The Alfred with an isolated hip fracture and treated with internal fixation, aged 65 or above
Exclusion Criteria:
- fracture is in the sub-trochanteric region of the femur,
- if it is pathological,
- if post operative orders are for non-weight bearing on the operated hip,
- if they were unable to mobilise independently (or with gait aid) prior to admission,
- or if they were admitted from a nursing home.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Usual care
usual care physiotherapy - once daily treatment whilst inpatient in acute hospital
|
once daily physiotherapy whilst acute hospital inpatient
|
|
Experimental: Intensive physiotherapy
additional once daily physiotherapy and once daily allied health assistant intervention
|
additional once daily physiotherapy and once daily allied health assistant intervention (equals two more treatments) whilst an inpatient in acute hospital
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
modified IOWA Level of Assistance Scale
Zeitfenster: 5 days
|
Functional score measuring 6 mobility domains
|
5 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
length of stay - acute and rehabilitation
Zeitfenster: participants will be followed for duration of hospital stay - average one month
|
the length of acute hospital stay and rehabilitation stay - until discharge home or to a long term facility
|
participants will be followed for duration of hospital stay - average one month
|
|
timed up and go
Zeitfenster: 5 days
|
5 days
|
|
|
Glasgow Outcomes Score -Extended
Zeitfenster: 6 months
|
6 months
|
|
|
discharge destination
Zeitfenster: participants will be followed until discharge from the acute hospital - average 10 days
|
discharge destination from the acute hospital - options include: home, fast stream rehabilitation, slow stream rehabilitation, long term facility
|
participants will be followed until discharge from the acute hospital - average 10 days
|
|
physical readiness for discharge
Zeitfenster: average one month
|
when a patient is deemed physically ready go home - eg can access their house and mobilise within house and outdoors
|
average one month
|
|
12-Item Short Form Health Survey (SF-12)
Zeitfenster: 6 months
|
6 months
|
|
|
EuroQOL five dimensions questionnaire (EQ-5D)
Zeitfenster: 6 months
|
6 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Lara A Kimmel, B.Physio, The Alfred
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 32/14
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