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Intensified In-hospital Physiotherapy for Patients After Hip Fracture Surgery. (IPPAHS)

B

Bispebjerg Hospital

Status

Completed

Conditions

Hip Fractures

Treatments

Other: Intensified physiotherapy
Other: Usual care physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04804527
P-2020-828

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Intensified physiotherapy
Experimental group
Description:
In addition to usual care physiotherapy patients in the intensified physiotherapy group will receive an extra physiotherapy session of up to 30 minutes on every weekday starting on the first postoperative day. The session will include progressive functional training of basic mobility and walking in the ward delivered by an experienced physiotherapist affiliated with the trial. The aim of this additional session is to improve the functional advances achieved during the earlier physiotherapy session.
Treatment:
Other: Intensified physiotherapy
Usual care physiotherapy
Active Comparator group
Description:
Patients will receive approximately 30 minutes physiotherapy once daily in the ward delivered by the ward's usual physiotherapists i.e. starting on the first postoperative day and thereafter primarily on weekdays until discharge (a mean of 8.82 days after admission). Usual care physiotherapy is individualized taking the patients ability and previous level of functioning into account and includes 1) progressive functional training of basic mobility e.g. in-out of bed, sit-to-stand and walking including progression in walking aid, stair training if possible, and advices toward better physical functional level, 2) basic bed exercises with progression to standing exercises according to a hand-out training program and recommendations on doing exercises daily and being as physical active as possible during the day.
Treatment:
Other: Usual care physiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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