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Completed

NCT Number: NCT04804527

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, Department of Physical & Occupational Therapy

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensified physiotherapy

Other

Physiotherapy x2

Usual care Physiotherapy

Other

Physiotherapy x1

Primary outcomes

  1. Total physiotherapy completion rate during hospitalization

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

    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.

Secondary outcomes

  1. Hip-fracture-related pain at rest

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

    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.

  2. Hip-fracture-related pain during physiotherapy

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

    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.

  3. Fatigue at rest

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

    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.

  4. Fatigue during physiotherapy

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

    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.

  5. Upright time during hospitalization

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

    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.

  6. Upright events during hospitalization

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

    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.

  7. Basic mobility assessed using The Cumulated Ambulation Score (CAS)

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

    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).

  8. Regain of pre-fracture basic mobility level at discharge

    Time frame: Baseline (pre-fracture) and at discharge an average of 8.82 days after admission

    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).

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Danske Fysioterapeuter
  • Gigtforeningen

Registry information

Official study title

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

Acronym: IPPAHS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2021
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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