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

Hip Fractures Clinical Trial

— IPPAHS  

Official title:

Intensified In-hospital Physiotherapy for Patients After Hip Fracture Surgery (IPPAHS). A Pragmatic, Randomized Feasibility Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04804527
• Other study ID #: P-2020-828
• Status: Completed
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: January 10, 2022

Study information

• Verified date: January 2022
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Other:
• Intensified physiotherapy
Physiotherapy x2
• Usual care physiotherapy
Physiotherapy x1

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Department of Physical & Occupational Therapy	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Danske Fysioterapeuter, Gigtforeningen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hip-fracture-related pain at rest	Measured at rest before physiotherapy using a five-point (no, slight, moderate, severe, unbearable pain) Verbal Rating Scale (VRS) on weekdays from the first postoperative day to discharge.	Through hospital stay, an average of 8.82 days after admission.
Secondary	Hip-fracture-related pain during physiotherapy	Measured during physiotherapy using a five-point (no, slight, moderate, severe, unbearable pain) Verbal Rating Scale (VRS) on weekdays from the first postoperative day to discharge.	Through hospital stay, an average of 8.82 days after admission.
Secondary	Fatigue at rest	Measured at rest before physiotherapy using a five-point (no, slight, moderate, severe, unbearable fatigue) Verbal Rating Scale (VRS) on weekdays from the first postoperative day to discharge.	Through hospital stay, an average of 8.82 days after admission.
Secondary	Fatigue during physiotherapy	Measured during physiotherapy using a five-point (no, slight, moderate, severe, unbearable fatigue) Verbal Rating Scale (VRS) on weekdays from the first postoperative day to discharge.	Through hospital stay, an average of 8.82 days after admission.
Secondary	Upright time during hospitalization	Time spend standing or walking assessed by using a body-worn accelerometer-based activity monitor (ActivePAL3c). The monitor will be attached to the thigh of the non-operated leg on the first postoperative day and the patient will wear the monitor continuously during hospitalization.	From the second postoperative day to discharge, though for a maximum of 10 days after surgery.
Secondary	Upright events during hospitalization	Transitions from sitting to standing assessed by using a body-worn accelerometer-based activity monitor (ActivePAL3c). The monitor will be attached to the thigh of the non-operated leg on the first postoperative day and the patient will wear the monitor continuously during hospitalization.	From the second postoperative day to discharge, though for a maximum of 10 days after surgery.
Secondary	Basic mobility assessed using The Cumulated Ambulation Score (CAS)	Basic mobility measured by using the Cumulated Ambulation Score (CAS) will be assessed in conjunction with every physiotherapy session on weekdays from the first postoperative day to discharge. The CAS is a tester administered score which describes the patient's independency in (1) getting in and out of bed, (2) sit to stand from a chair, and (3) walking ability (with and without walking aid). Each activity is assessed on a three-point ordinal scale from 0 to 2 (0: Not able to with human assistance and verbal cueing, 1: able to with human assistance or verbal cueing 2: Able to safely without human assistance or verbal cueing) resulting in a total CAS score between 0 and 6 (6 indicating independent ambulation).	Through hospital stay, an average of 8.82 days after admission.
Secondary	Regain of pre-fracture basic mobility level at discharge	Basic mobility measured by using the Cumulated Ambulation Score (CAS). The CAS is a tester administered score which describes the patient's independency in (1) getting in and out of bed, (2) sit to stand from a chair, and (3) walking ability (with and without walking aid). Each activity is assessed on a three-point ordinal scale from 0 to 2 (0: Not able to with human assistance and verbal cueing, 1: able to with human assistance or verbal cueing 2: Able to safely without human assistance or verbal cueing) resulting in a total CAS score between 0 and 6 (6 indicating independent ambulation).	Baseline (pre-fracture) and at discharge an average of 8.82 days after admission