Clinical trial NCT04804527: Intensified In-hospital Physiotherapy for Patients After Hip Fracture Surgery.
Official title: Intensified In-hospital Physiotherapy for Patients After Hip Fracture Surgery (IPPAHS). A Pragmatic, Randomized Feasibility Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: Exercise Therapy
Physical Therapy Modalities
Mobility Limitation
Feasibility Studies
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Gigtforeningen
name: Danske Fysioterapeuter
First posted: 2021-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pragmatic, randomized, controlled, unblinded feasibility trial with two parallel groups: an intervention group receiving intensified acute in-hospital physiotherapy (n=40) and a control group receiving usual care acute in-hospital physiotherapy (n=20).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Regaining basis mobility after a hip fracture surgery is an important in-hospital rehabilitation goal because patients who have regained basis mobility at pre-fracture level at discharge have lower 30-day mortality and readmission rate and are more likely to be discharged to their own home. However, at discharge only half of the patients have regained their pre-fracture basis mobility level.

Intensified acute in-hospital physiotherapy (e.g. more than once daily) highlighting weight-bearing activities and ambulation could have a positive effect on the proportion of patients who regain their pre-facture basic mobility at discharge. However, data from daily clinical practice suggest that only half of the patients are able to complete physiotherapy on the first postoperative day and that fatigue, hip fracture-related pain and habitual cognitive status are the most frequent reasons for not completing planned physiotherapy (once daily) during the first three postoperative days. Thus to undertake an RCT investigating the effect of intensified acute in-hospital physiotherapy i.e. two daily sessions of physiotherapy compared to usual care i.e. one daily session, on regained pre-facture basic mobility at discharge in patients with hip fracture raises important practical concerns regarding e.g. completion rate of planned physiotherapy. The potential positive effects of intensified physiotherapy will be hampered if too many patients are unable to complete planned physiotherapy e.g. because of fatigue or pain. Feasibility studies ask whether something can be done and are preliminary studies conducted specifically for the purposes of establishing whether or not a full trial will be feasible to conduct. Thus, the main aim of the trial is to assess the feasibility of conducting a definitive pragmatic RCT in terms of implementation, practicality and acceptability of intensified acute in-hospital physiotherapy i.e. two daily sessions of physiotherapy highlighting weight-bearing activities and ambulation on weekdays among patients with hip fracture.

The main predefined feasibility criterium is that about twice as many physiotherapy sessions are completed in the intensified physiotherapy group compared to in the usual care physiotherapy group.


Eligibility criteria: Inclusion Criteria:

A patient will be eligible for study participation if he/she meets the following criteria:

* Diagnosed with an isolated, first time hip fracture on the affected side
* Age ≥ 65 years
* Able to speak and understand Danish
* Home-dwelling with an independent pre-fracture ability to walk indoors (New Mobility Score (NMS) ≥ 2)
* Able to give written informed consent prior to physiotherapy in the first postoperative day

Exclusion Criteria:

A participant will be excluded from the study if he/she meets any of the following criteria:

* The fracture is pathological (e.g. cancer-based)
* Postoperative weight-bearing is restricted
* Multiple body fractures are present
* Serious postoperative medical complications occur
* Any other conditions that in the opinion of the investigator makes a potential participant unfit for participation

Primary outcomes:
measure: Total physiotherapy completion rate during hospitalization
timeFrame: Through hospital stay, an average of 8.82 days after admission.
Secondary outcomes:
measure: Hip-fracture-related pain at rest
timeFrame: Through hospital stay, an average of 8.82 days after admission.
measure: Hip-fracture-related pain during physiotherapy
timeFrame: Through hospital stay, an average of 8.82 days after admission.
measure: Fatigue at rest
timeFrame: Through hospital stay, an average of 8.82 days after admission.
measure: Fatigue during physiotherapy
timeFrame: Through hospital stay, an average of 8.82 days after admission.
measure: Upright time during hospitalization
timeFrame: From the second postoperative day to discharge, though for a maximum of 10 days after surgery.
measure: Upright events during hospitalization
timeFrame: From the second postoperative day to discharge, though for a maximum of 10 days after surgery.
measure: Basic mobility assessed using The Cumulated Ambulation Score (CAS)
timeFrame: Through hospital stay, an average of 8.82 days after admission.
measure: Regain of pre-fracture basic mobility level at discharge
timeFrame: Baseline (pre-fracture) and at discharge an average of 8.82 days after admission
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, Department of Physical & Occupational Therapy
Study officials:
affiliation: Bispebjerg and Frederiksberg Hospital, Dept. of Physical & Occupational Therapy
name: Theresa Bieler, PhD
role: STUDY_DIRECTOR
References: