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

NCT04804527 | Completed

• 1 other identifier: P-2020-828
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Keywords

Exercise Therapy; Physical Therapy Modalities; Mobility Limitation; Feasibility Studies

Outcome Measures

Primary Outcomes (1)

• Total physiotherapy completion rate during hospitalization

  The degree of completion (successful completion, partial completion or cancellation) of every physiotherapy session on weekdays from the first postoperative day to discharge will be rated by the physiotherapists and total physiotherapy completion rate during hospitalization will be calculated. The physiotherapists will also register cause of partial completion or cancellation.

  Through hospital stay, an average of 8.82 days after admission.

Secondary Outcomes (8)

• Hip-fracture-related pain at rest

  Through hospital stay, an average of 8.82 days after admission.

• Hip-fracture-related pain during physiotherapy

  Through hospital stay, an average of 8.82 days after admission.

• Fatigue at rest

  Through hospital stay, an average of 8.82 days after admission.

• Fatigue during physiotherapy

  Through hospital stay, an average of 8.82 days after admission.

• Upright time during hospitalization

  From the second postoperative day to discharge, though for a maximum of 10 days after surgery.

Study Arms (2)

Intensified physiotherapy

EXPERIMENTAL

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.

Other: Intensified physiotherapy

Usual care physiotherapy

ACTIVE COMPARATOR

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.

Other: Usual care physiotherapy

Interventions

Intensified physiotherapy OTHER

Physiotherapy x2

Intensified physiotherapy

Usual care physiotherapy OTHER

Physiotherapy x1

Usual care physiotherapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Gigtforeningen: collaborator
• Danske Fysioterapeuter: collaborator

Study Sites (1)

Bispebjerg Hospital, Department of Physical & Occupational Therapy

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Hip Fractures; Mobility Limitation

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Theresa Bieler, PhD

  Bispebjerg and Frederiksberg Hospital, Dept. of Physical & Occupational Therapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Therapist

Model Details: 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).

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 18, 2021
• Study Start: April 9, 2021
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)